Pub Date : 2024-09-20DOI: 10.1016/j.ajcnut.2024.09.020
Carla Wunderle, Sandra S Suter, Nele Endner, Eliane Haenggi, Nina Kaegi-Braun, Pascal Tribolet, Zeno Stanga, Beat Mueller, Philipp Schuetz
Background: Considering sex-specific factors has become an increasingly recognized area for research and practice. In the field of clinical nutrition, there is insufficient evidence regarding differences in clinical presentation, treatment response, and side effects of nutritional therapy among female and male patients.
Methods: This secondary analysis investigated differences among female and male patients at risk for malnutrition regarding initial presentation, clinical outcomes, and treatment response in patients included in the Effect of Early NutritionalSupporton Frailty, Functional Outcomes, and Recovery of Malnourished Medical Inpatients Trial (EFFORT), a randomized controlled trial comparing individualized nutritional support to usual care.
Results: Of 2,028 patients included in the trial 964 were female and 1,064 were male. The nutritional history and clinical presentation of female patients was different: they consumed less food and had a greater loss of appetite than the male population. Male patients had higher risk for mortality at 180 days (27% compared to 19%, adjusted HR 1.35 [95%CI 1.12, 1.63]) and further adverse clinical outcomes. However, there was no difference in the effect of nutritional support on mortality among female and male patients (HR 0.76 [95%CI 0.45, 1.27] compared to 0.81 [95%CI 0.54, 1.21]; p for interaction =0.939).
Conclusion: Results of this multicenter randomized trial suggest that multimorbid female inpatients, have a different clinical presentation and are more prone to loss of appetite and reduced daily dietary intake compared to male inpatients. Importantly, the favorable response to nutritional interventions was similar in both sexes.
{"title":"Sex differences in clinical presentation, treatment response, and side effects of nutritional therapy among patients at nutritional risk A secondary analysis of the randomized clinical trial EFFORT.","authors":"Carla Wunderle, Sandra S Suter, Nele Endner, Eliane Haenggi, Nina Kaegi-Braun, Pascal Tribolet, Zeno Stanga, Beat Mueller, Philipp Schuetz","doi":"10.1016/j.ajcnut.2024.09.020","DOIUrl":"https://doi.org/10.1016/j.ajcnut.2024.09.020","url":null,"abstract":"<p><strong>Background: </strong>Considering sex-specific factors has become an increasingly recognized area for research and practice. In the field of clinical nutrition, there is insufficient evidence regarding differences in clinical presentation, treatment response, and side effects of nutritional therapy among female and male patients.</p><p><strong>Methods: </strong>This secondary analysis investigated differences among female and male patients at risk for malnutrition regarding initial presentation, clinical outcomes, and treatment response in patients included in the Effect of Early NutritionalSupporton Frailty, Functional Outcomes, and Recovery of Malnourished Medical Inpatients Trial (EFFORT), a randomized controlled trial comparing individualized nutritional support to usual care.</p><p><strong>Results: </strong>Of 2,028 patients included in the trial 964 were female and 1,064 were male. The nutritional history and clinical presentation of female patients was different: they consumed less food and had a greater loss of appetite than the male population. Male patients had higher risk for mortality at 180 days (27% compared to 19%, adjusted HR 1.35 [95%CI 1.12, 1.63]) and further adverse clinical outcomes. However, there was no difference in the effect of nutritional support on mortality among female and male patients (HR 0.76 [95%CI 0.45, 1.27] compared to 0.81 [95%CI 0.54, 1.21]; p for interaction =0.939).</p><p><strong>Conclusion: </strong>Results of this multicenter randomized trial suggest that multimorbid female inpatients, have a different clinical presentation and are more prone to loss of appetite and reduced daily dietary intake compared to male inpatients. Importantly, the favorable response to nutritional interventions was similar in both sexes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02517476.</p>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-20DOI: 10.1016/j.ajcnut.2024.09.018
Minsoo Son, Marie L Laury, Kevin B Stephenson, Thaddaeus May, D Taylor Hendrixson, Aminata Shamit Koroma, Amara Stevens Ngegbai, Jong Hee Song, Nino Naskidashvili, Young Ah Goo, Mark J Manary
Background & aims: Our objectives were to determine the effect of dietary milk protein and milk carbohydrate on the intestinal permeability, fecal 16S rRNA gene configuration, and fecal metabolomics of children with moderate malnutrition.
Methods: This was a randomized, double-blind, controlled trial among 413 children with wasting in rural Sierra Leone who received one of four supplementary foods. The foods differed in sources of protein and carbohydrate: milk protein and milk carbohydrate (MPMC), milk protein and vegetable carbohydrate (MPVC), vegetable protein and milk carbohydrate (VPMC), or a control group consuming entirely vegetable-based food (VPVC). After 4 weeks, urine and stool were collected from participants enrolled with mid-upper arm circumference < 12.1 cm. Urine was analyzed for lactulose excretion (%L). Stools underwent both 16S rRNA gene analysis to assess β diversity and untargeted metabolomic abundance.
Results: Among the 386 children who completed permeability testing, the mean difference (95% CI) in %L excretion as compared with VPVC was 0.01 (-0.05, 0.07) for MPMC, 0.05 (-0.01, 0.11) for MPVC, and 0.01 (-0.05, 0.07) for VPMC. Of the 374 children who provided a stool sample that was analyzed , the β diversity among bacterial taxa was similar between dietary groups (P>0.05 for all comparisons). No significant differences between dietary groups were seen among the 20 most abundant bacterial taxa. Among the 5,769 unique metabolomic features identified, greater flavonoid levels in VPVC were seen.
Conclusions: Abnormal intestinal permeability did not improve with 4 weeks of supplementary feeding. Fecal rRNA did not differ with consumption of different diets. Trial registration ClinicalTrials.gov (NCT04216043).
Trial registration: Clinicaltrails.gov NCT04216043URL of registration: https://clinicaltrials.gov/study/NCT04216043?id=NCT04216043&rank=1.
{"title":"The impact of milk on gut permeability, fecal 16S rRNA gene microbiota profiling and fecal metabolomics in children with moderate malnutrition in Sierra Leone: a double-blind, randomized controlled trial.","authors":"Minsoo Son, Marie L Laury, Kevin B Stephenson, Thaddaeus May, D Taylor Hendrixson, Aminata Shamit Koroma, Amara Stevens Ngegbai, Jong Hee Song, Nino Naskidashvili, Young Ah Goo, Mark J Manary","doi":"10.1016/j.ajcnut.2024.09.018","DOIUrl":"https://doi.org/10.1016/j.ajcnut.2024.09.018","url":null,"abstract":"<p><strong>Background & aims: </strong>Our objectives were to determine the effect of dietary milk protein and milk carbohydrate on the intestinal permeability, fecal 16S rRNA gene configuration, and fecal metabolomics of children with moderate malnutrition.</p><p><strong>Methods: </strong>This was a randomized, double-blind, controlled trial among 413 children with wasting in rural Sierra Leone who received one of four supplementary foods. The foods differed in sources of protein and carbohydrate: milk protein and milk carbohydrate (MPMC), milk protein and vegetable carbohydrate (MPVC), vegetable protein and milk carbohydrate (VPMC), or a control group consuming entirely vegetable-based food (VPVC). After 4 weeks, urine and stool were collected from participants enrolled with mid-upper arm circumference < 12.1 cm. Urine was analyzed for lactulose excretion (%L). Stools underwent both 16S rRNA gene analysis to assess β diversity and untargeted metabolomic abundance.</p><p><strong>Results: </strong>Among the 386 children who completed permeability testing, the mean difference (95% CI) in %L excretion as compared with VPVC was 0.01 (-0.05, 0.07) for MPMC, 0.05 (-0.01, 0.11) for MPVC, and 0.01 (-0.05, 0.07) for VPMC. Of the 374 children who provided a stool sample that was analyzed , the β diversity among bacterial taxa was similar between dietary groups (P>0.05 for all comparisons). No significant differences between dietary groups were seen among the 20 most abundant bacterial taxa. Among the 5,769 unique metabolomic features identified, greater flavonoid levels in VPVC were seen.</p><p><strong>Conclusions: </strong>Abnormal intestinal permeability did not improve with 4 weeks of supplementary feeding. Fecal rRNA did not differ with consumption of different diets. Trial registration ClinicalTrials.gov (NCT04216043).</p><p><strong>Trial registration: </strong>Clinicaltrails.gov NCT04216043URL of registration: https://clinicaltrials.gov/study/NCT04216043?id=NCT04216043&rank=1.</p>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-19DOI: 10.1016/j.ajcnut.2024.09.014
Rebecca J Moon, Stefania D' Angelo, Elizabeth M Curtis, Kate A Ward, Sarah R Crozier, Inez Schoenmakers, M Kassim Javaid, Nicholas J Bishop, Keith M Godfrey, Cyrus Cooper, Nicholas C Harvey
Background: Findings from the MAVIDOS trial demonstrated a positive effect of gestational cholecalciferol supplementation on offspring bone mineral density (BMD) at age 4 years. Demonstrating persistence of this effect is important to understanding whether maternal vitamin D supplementation could be a useful public health strategy to improving bone health.
Objective: We investigated whether gestational vitamin D supplementation increases offspring BMD at 6-7 years in an exploratory post-hoc analysis of an existing trial.
Methods: In the MAVIDOS randomised controlled trial, pregnant females <14 weeks' gestation with a singleton pregnancy and serum 25-hydroxyvitamin D [25(OH)D] 25-100nmol/l at three UK hospitals (Southampton, Sheffield and Oxford) were randomised to either 1000 IU/day cholecalciferol or placebo from 14-17 weeks gestation until delivery. Offspring born at term to participants recruited in Southampton were invited to the childhood follow-up at 4 and 6-7 years. The children had a dual-energy X-ray absorptiometry (DXA, Hologic discovery) scan of whole-body-less-head (WBLH) and lumbar spine, from which bone area [BA], bone mineral content [BMC], BMD and bone mineral apparent density [BMAD]) were derived. Linear regression was used to compare the two groups adjusting for age, sex, height, weight, duration of consumption of human milk and vitamin D use at 6-7 years.
Results: 454 children were followed up at age 6-7 years, of whom 447 had a usable DXA scan. Gestational cholecalciferol supplementation resulted in higher WBLH BMC (0.15 SD, 95%CI 0.04, 0.26), BMD (0.18 SD, 95%CI 0.06,0.31), BMAD (0.18 SD, 95%CI 0.04,0.32) and lean mass (0.09 SD, 95%CI 0.00,0.17) compared to placebo. The effect of pregnancy cholecalciferol on bone outcomes was similar at ages 4 and 6-7 years.
Conclusions and relevance: Supplementation with cholecalciferol 1000 IU/day during pregnancy resulted in greater offspring BMD and lean mass in mid-childhood versus placebo in this exploratory post-hoc analysis. These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health.
{"title":"Pregnancy vitamin D supplementation and offspring bone mineral density in childhood Follow-up of a randomised controlled trial.","authors":"Rebecca J Moon, Stefania D' Angelo, Elizabeth M Curtis, Kate A Ward, Sarah R Crozier, Inez Schoenmakers, M Kassim Javaid, Nicholas J Bishop, Keith M Godfrey, Cyrus Cooper, Nicholas C Harvey","doi":"10.1016/j.ajcnut.2024.09.014","DOIUrl":"https://doi.org/10.1016/j.ajcnut.2024.09.014","url":null,"abstract":"<p><strong>Background: </strong>Findings from the MAVIDOS trial demonstrated a positive effect of gestational cholecalciferol supplementation on offspring bone mineral density (BMD) at age 4 years. Demonstrating persistence of this effect is important to understanding whether maternal vitamin D supplementation could be a useful public health strategy to improving bone health.</p><p><strong>Objective: </strong>We investigated whether gestational vitamin D supplementation increases offspring BMD at 6-7 years in an exploratory post-hoc analysis of an existing trial.</p><p><strong>Methods: </strong>In the MAVIDOS randomised controlled trial, pregnant females <14 weeks' gestation with a singleton pregnancy and serum 25-hydroxyvitamin D [25(OH)D] 25-100nmol/l at three UK hospitals (Southampton, Sheffield and Oxford) were randomised to either 1000 IU/day cholecalciferol or placebo from 14-17 weeks gestation until delivery. Offspring born at term to participants recruited in Southampton were invited to the childhood follow-up at 4 and 6-7 years. The children had a dual-energy X-ray absorptiometry (DXA, Hologic discovery) scan of whole-body-less-head (WBLH) and lumbar spine, from which bone area [BA], bone mineral content [BMC], BMD and bone mineral apparent density [BMAD]) were derived. Linear regression was used to compare the two groups adjusting for age, sex, height, weight, duration of consumption of human milk and vitamin D use at 6-7 years.</p><p><strong>Results: </strong>454 children were followed up at age 6-7 years, of whom 447 had a usable DXA scan. Gestational cholecalciferol supplementation resulted in higher WBLH BMC (0.15 SD, 95%CI 0.04, 0.26), BMD (0.18 SD, 95%CI 0.06,0.31), BMAD (0.18 SD, 95%CI 0.04,0.32) and lean mass (0.09 SD, 95%CI 0.00,0.17) compared to placebo. The effect of pregnancy cholecalciferol on bone outcomes was similar at ages 4 and 6-7 years.</p><p><strong>Conclusions and relevance: </strong>Supplementation with cholecalciferol 1000 IU/day during pregnancy resulted in greater offspring BMD and lean mass in mid-childhood versus placebo in this exploratory post-hoc analysis. These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health.</p><p><strong>Trial registration: </strong>ISRCTN:82927713 https://doi.org/10.1186/ISRCTN82927713; EUDRACT:2007-001716-23 https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001716-23/results.</p>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-14DOI: 10.1016/j.ajcnut.2024.09.007
Elizabeth F Racine, Lilian O Ademu, Alicia Anne Dahl, Stacy M Fandetti, Lisa Schulkind
Background: The Patient Protection US Affordable Care Act (ACA) energy posting mandate requires restaurant chains to disclose information on the energy content of their food items. Assessments of the effect of menu energy labeling on dietary choices have reported inconsistent findings.
Objectives: This study examined the impact of menu energy labeling on food items purchased by college students after the mandate was enacted nationally.
Methods: Student food sales data from purchases made at 3 fast-food restaurants during the 2017/2018 and 2018/2019 academic years at a university campus were used for the analysis. The total sample included 1662 students on the university meal plan; these students generated 145,295 food transactions at the restaurants over the study period. We utilized a difference-in-differences (DiD) empirical strategy, comparing changes in transaction-level energy purchases at 2 fast-food restaurants B and C (FFRB and FFRC - treatment groups) that posted energy information in the summer of 2018 with another fast-food restaurant A (FFRA - control group) that began posting energy information before the study period.
Results: We observed increases in the mean energy content per transaction after implementing the menu-labeling policy. The DiD estimates found an increase of 20.6 in the mean calories of energy purchased per transaction at the treatment restaurants relative to the control restaurant. In the subgroup analyses, the DiD estimates indicated calories of energy increased: 18.7 for female students, 20.5 for male students, 23.5 for non-Hispanic Black students, 30.2 for students eligible for federal financial aid, and 19.9 for students not eligible for federal financial aid.
Conclusions: The results suggest that the ACA energy menu-labeling policy led to an increase in the energy content per transaction by students at a public university. This paper highlights the need for more research to better understand the determinants of food choice among college students.
{"title":"The impact of fast-food energy posting on college students' food purchases.","authors":"Elizabeth F Racine, Lilian O Ademu, Alicia Anne Dahl, Stacy M Fandetti, Lisa Schulkind","doi":"10.1016/j.ajcnut.2024.09.007","DOIUrl":"10.1016/j.ajcnut.2024.09.007","url":null,"abstract":"<p><strong>Background: </strong>The Patient Protection US Affordable Care Act (ACA) energy posting mandate requires restaurant chains to disclose information on the energy content of their food items. Assessments of the effect of menu energy labeling on dietary choices have reported inconsistent findings.</p><p><strong>Objectives: </strong>This study examined the impact of menu energy labeling on food items purchased by college students after the mandate was enacted nationally.</p><p><strong>Methods: </strong>Student food sales data from purchases made at 3 fast-food restaurants during the 2017/2018 and 2018/2019 academic years at a university campus were used for the analysis. The total sample included 1662 students on the university meal plan; these students generated 145,295 food transactions at the restaurants over the study period. We utilized a difference-in-differences (DiD) empirical strategy, comparing changes in transaction-level energy purchases at 2 fast-food restaurants B and C (FFRB and FFRC - treatment groups) that posted energy information in the summer of 2018 with another fast-food restaurant A (FFRA - control group) that began posting energy information before the study period.</p><p><strong>Results: </strong>We observed increases in the mean energy content per transaction after implementing the menu-labeling policy. The DiD estimates found an increase of 20.6 in the mean calories of energy purchased per transaction at the treatment restaurants relative to the control restaurant. In the subgroup analyses, the DiD estimates indicated calories of energy increased: 18.7 for female students, 20.5 for male students, 23.5 for non-Hispanic Black students, 30.2 for students eligible for federal financial aid, and 19.9 for students not eligible for federal financial aid.</p><p><strong>Conclusions: </strong>The results suggest that the ACA energy menu-labeling policy led to an increase in the energy content per transaction by students at a public university. This paper highlights the need for more research to better understand the determinants of food choice among college students.</p>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-14DOI: 10.1016/j.ajcnut.2024.09.013
Dafna Pachter, Alon Kaplan, Gal Tsaban, Hila Zelicha, Anat Yaskolka Meir, Ehud Rinott, Gidon Levakov, Moti Salti, Yoram Yovell, Sebastian Huhn, Frauke Beyer, Veronica Witte, Peter Kovacs, Martin von Bergen, Uta Ceglarek, Matthias Blüher, Michael Stumvoll, Frank B Hu, Meir J Stampfer, Alon Friedman, Ilan Shelef, Galia Avidan, Iris Shai
Background: We recently reported that Mediterranean (MED) and green-MED diets significantly attenuated age-related brain atrophy by ∼50% within 18 mo.
Objective: The objective of this study was to explore the contribution of specific diet-induced parameters to brain-volume deviation from chronologic age.
Methods: A post hoc analysis of the 18-mo DIRECT-PLUS trial, where participants were randomly assigned to the following groups: 1) healthy dietary guidelines, 2) MED diet, or 3) green-MED diet, high in polyphenols, and low in red meat. Both MED groups consumed 28 g walnuts/d (+440 mg/d polyphenols). The green-MED group further consumed green tea (3-4 cups/d) and Mankai green shake (Wolffia globosa aquatic plant) (+800 mg/d polyphenols). We collected blood samples through the intervention and followed brain structure volumes by magnetic resonance imaging (MRI). We used hippocampal occupancy (HOC) score (hippocampal and inferior lateral-ventricle volumes ratio) as a neurodegeneration marker and brain-age proxy. We applied multivariate linear regression models.
Results: Of 284 participants [88% male; age = 51.1 y; body mass index = 31.2 kg/m2; hemoglobin A1c (HbA1c) = 5.48%; APOE-ε4 genotype = 15.7%], 224 completed the trial with eligible whole-brain MRIs. Individuals with higher HOC deviations (i.e., younger brain age) presented lower body weight [r = -0.204; 95% confidence interval (CI): -0.298, -0.101], waist circumference (r = -0.207; 95% CI: -0.310, -0.103), diastolic (r = -0.186; 95% CI: -0.304, -0.072), systolic blood pressure (r = -0.189; 95% CI: -0.308, -0.061), insulin (r = -0.099; 95% CI: -0.194, -0.004), and HbA1c (r = -0.164; 95% CI: -0.337, -0.006) concentrations. After 18 mo, greater changes in HOC deviations (i.e., brain-age decline attenuation) were independently associated with improved HbA1c (β = -0.254; 95% CI: -0.392, -0.117), HOMA-IR (β = -0.200; 95% CI: -0.346, -0.055), fasting glucose (β = -0.155; 95% CI: -0.293, -0.016), and s-reactive protein (β = -0.153; 95% CI: -0.296, -0.010). Improvement in diabetes status was associated with greater HOC deviation changes than either no change in diabetes status (0.010; 95% CI: 0.002, 0.019) or with an unfavorable change (0.012; 95% CI: 0.002, 0.023). A decline in HbA1c is further associated with greater deviation changes in the thalamus, caudate nucleus, and cerebellum (P < 0.05). Greater consumption of Mankai and green tea (green-MED diet components) were associated with greater HOC deviation changes beyond weight loss.
Conclusions: Glycemic control contributes to the neuroprotective effects of the MED and green-MED diets on brain age. Polyphenols-rich diet components as Mankai and green tea may contribute to a more youthful brain age. This trial was registered at clinicaltrials.gov at clinicaltrials.gov as NCT03020186.
{"title":"Glycemic control contributes to the neuroprotective effects of Mediterranean and green Mediterranean diets on brain age: the DIRECT-PLUS brain-magnetic resonance imaging randomized controlled trial.","authors":"Dafna Pachter, Alon Kaplan, Gal Tsaban, Hila Zelicha, Anat Yaskolka Meir, Ehud Rinott, Gidon Levakov, Moti Salti, Yoram Yovell, Sebastian Huhn, Frauke Beyer, Veronica Witte, Peter Kovacs, Martin von Bergen, Uta Ceglarek, Matthias Blüher, Michael Stumvoll, Frank B Hu, Meir J Stampfer, Alon Friedman, Ilan Shelef, Galia Avidan, Iris Shai","doi":"10.1016/j.ajcnut.2024.09.013","DOIUrl":"10.1016/j.ajcnut.2024.09.013","url":null,"abstract":"<p><strong>Background: </strong>We recently reported that Mediterranean (MED) and green-MED diets significantly attenuated age-related brain atrophy by ∼50% within 18 mo.</p><p><strong>Objective: </strong>The objective of this study was to explore the contribution of specific diet-induced parameters to brain-volume deviation from chronologic age.</p><p><strong>Methods: </strong>A post hoc analysis of the 18-mo DIRECT-PLUS trial, where participants were randomly assigned to the following groups: 1) healthy dietary guidelines, 2) MED diet, or 3) green-MED diet, high in polyphenols, and low in red meat. Both MED groups consumed 28 g walnuts/d (+440 mg/d polyphenols). The green-MED group further consumed green tea (3-4 cups/d) and Mankai green shake (Wolffia globosa aquatic plant) (+800 mg/d polyphenols). We collected blood samples through the intervention and followed brain structure volumes by magnetic resonance imaging (MRI). We used hippocampal occupancy (HOC) score (hippocampal and inferior lateral-ventricle volumes ratio) as a neurodegeneration marker and brain-age proxy. We applied multivariate linear regression models.</p><p><strong>Results: </strong>Of 284 participants [88% male; age = 51.1 y; body mass index = 31.2 kg/m<sup>2</sup>; hemoglobin A1c (HbA1c) = 5.48%; APOE-ε4 genotype = 15.7%], 224 completed the trial with eligible whole-brain MRIs. Individuals with higher HOC deviations (i.e., younger brain age) presented lower body weight [r = -0.204; 95% confidence interval (CI): -0.298, -0.101], waist circumference (r = -0.207; 95% CI: -0.310, -0.103), diastolic (r = -0.186; 95% CI: -0.304, -0.072), systolic blood pressure (r = -0.189; 95% CI: -0.308, -0.061), insulin (r = -0.099; 95% CI: -0.194, -0.004), and HbA1c (r = -0.164; 95% CI: -0.337, -0.006) concentrations. After 18 mo, greater changes in HOC deviations (i.e., brain-age decline attenuation) were independently associated with improved HbA1c (β = -0.254; 95% CI: -0.392, -0.117), HOMA-IR (β = -0.200; 95% CI: -0.346, -0.055), fasting glucose (β = -0.155; 95% CI: -0.293, -0.016), and s-reactive protein (β = -0.153; 95% CI: -0.296, -0.010). Improvement in diabetes status was associated with greater HOC deviation changes than either no change in diabetes status (0.010; 95% CI: 0.002, 0.019) or with an unfavorable change (0.012; 95% CI: 0.002, 0.023). A decline in HbA1c is further associated with greater deviation changes in the thalamus, caudate nucleus, and cerebellum (P < 0.05). Greater consumption of Mankai and green tea (green-MED diet components) were associated with greater HOC deviation changes beyond weight loss.</p><p><strong>Conclusions: </strong>Glycemic control contributes to the neuroprotective effects of the MED and green-MED diets on brain age. Polyphenols-rich diet components as Mankai and green tea may contribute to a more youthful brain age. This trial was registered at clinicaltrials.gov at clinicaltrials.gov as NCT03020186.</p>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.ajcnut.2024.06.009
Background
Computed tomography (CT) has an underutilized potential for evaluating body composition in clinical settings. Often conducted with intravenous contrast (IVC), CT scans yield unused body composition data due to unclear effects on skeletal muscle area (SMA), skeletal muscle index (SMI), and muscle density (SMD).
Objectives
This study investigates whether weight-adjusted IVC influences SMA, SMI, and SMD differently in females and males compared with noncontrast abdominal CT. In addition, the study explores associations between contrast and noncontrast-assessed SMA, SMI, SMD, and demographic factors.
Methods
A comparative observational retrospective study was conducted on Danish patients who underwent consecutive 4-phased contrast-enhanced abdominal CT scans (noncontrast, arterial, venous, and late venous phases). Muscle measures were evaluated using validated semiautomated threshold-based software by 3 independent raters.
Results
The study included 72 patients (51 males and 21 females) with a mean age of 59 (55 and 62) y. Weight-adjusted IVC increased SMA by ≤3.28 cm2 (95% confidence interval [CI]: 2.58, 3.98) corresponding to 2.4% (1.8, 2.9) in the late venous phase compared with noncontrast CT. Analysis between sexes showed no difference in the effects of IVC on SMA and SMI between females and males. However, females exhibited a higher increase in SMD during the venous by a mean of 1.7 HU (0.9; 2.5) and late venous phases with a mean HU of 1.80 (1.0; 2.6) compared with males. Multivariate regression analysis indicated an association between the differences in SMD and sex during venous (–1.38, 95% CI: –2.48, –0.48) and late venous phases (–1.23, 95% CI: –2.27, –0.19).
Conclusions
Weight-adjusted IVC leads to increased SMA, SMI, and SMD. Although SMA and SMI differences were consistent across the sexes, females exhibited a significantly higher SMD increase than males in the venous and late venous phases. Further investigations are necessary to determine the applicability of SMD as a muscle quality proxy in IVC CT scans.
{"title":"Influence of weight-adjusted contrast enhancement on computed tomography-derived skeletal muscle measures: a retrospective proof-of-concept comparative study between Danish females and males","authors":"","doi":"10.1016/j.ajcnut.2024.06.009","DOIUrl":"10.1016/j.ajcnut.2024.06.009","url":null,"abstract":"<div><h3>Background</h3><p>Computed tomography (CT) has an underutilized potential for evaluating body composition in clinical settings. Often conducted with intravenous contrast (IVC), CT scans yield unused body composition data due to unclear effects on skeletal muscle area (SMA), skeletal muscle index (SMI), and muscle density (SMD).</p></div><div><h3>Objectives</h3><p>This study investigates whether weight-adjusted IVC influences SMA, SMI, and SMD differently in females and males compared with noncontrast abdominal CT. In addition, the study explores associations between contrast and noncontrast-assessed SMA, SMI, SMD, and demographic factors.</p></div><div><h3>Methods</h3><p>A comparative observational retrospective study was conducted on Danish patients who underwent consecutive 4-phased contrast-enhanced abdominal CT scans (noncontrast, arterial, venous, and late venous phases). Muscle measures were evaluated using validated semiautomated threshold-based software by 3 independent raters.</p></div><div><h3>Results</h3><p>The study included 72 patients (51 males and 21 females) with a mean age of 59 (55 and 62) y. Weight-adjusted IVC increased SMA by ≤3.28 cm<sup>2</sup> (95% confidence interval [CI]: 2.58, 3.98) corresponding to 2.4% (1.8, 2.9) in the late venous phase compared with noncontrast CT. Analysis between sexes showed no difference in the effects of IVC on SMA and SMI between females and males. However, females exhibited a higher increase in SMD during the venous by a mean of 1.7 HU (0.9; 2.5) and late venous phases with a mean HU of 1.80 (1.0; 2.6) compared with males. Multivariate regression analysis indicated an association between the differences in SMD and sex during venous (–1.38, 95% CI: –2.48, –0.48) and late venous phases (–1.23, 95% CI: –2.27, –0.19).</p></div><div><h3>Conclusions</h3><p>Weight-adjusted IVC leads to increased SMA, SMI, and SMD. Although SMA and SMI differences were consistent across the sexes, females exhibited a significantly higher SMD increase than males in the venous and late venous phases. Further investigations are necessary to determine the applicability of SMD as a muscle quality proxy in IVC CT scans.</p></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002916524005781/pdfft?md5=36b6bf063a5d61cbbb9742cd645d2b27&pid=1-s2.0-S0002916524005781-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141472232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.ajcnut.2024.06.014
Background
The influence of adherence to a planetary health diet (PHD) proposed by the EAT-Lancet Commission on cardiovascular disease (CVD) is inconclusive. Besides, whether genetic susceptibility to CVD can modify the association of PHD with CVD remains unknown.
Objective
We aimed to investigate the association between adherence to PHD and CVD, and to evaluate the interaction between PHD and genetic predisposition to CVD.
Methods
This study included 114,165 participants who completed at least two 24-h dietary recalls and were initially free of CVD from the UK Biobank. PHD score was calculated to assess adherence to PHD. Genetic risk was evaluated using the polygenic risk score. Incidence of total CVD, ischemic heart disease (IHD), atrial fibrillation (AF), heart failure (HF), and stroke were identified via electronic health records. Cox proportional hazard regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).
Results
During a median follow-up of 9.9 y, 10,071 (8.8%) incident CVD cases were documented. Compared with participants with the lowest adherence to PHD, HRs (95% CIs) for total CVD, IHD, AF, HF, and stroke among those with the highest adherence were 0.79 (0.74, 0.84), 0.73 (0.67, 0.79), 0.90 (0.82, 0.99), 0.69 (0.59, 0.82), and 0.88 (0.75, 1.04), respectively. No significant interaction between the genetic risk of CVD and PHD was observed. Participants with high genetic risk and low PHD score, as compared with those with low genetic risk and high PHD score, had a 48% (95% CI: 40%, 56%) higher risk of CVD. The population-attributable risk (95% CI) of CVD for poor adherence to PHD ranged from 8.79% (5.36%, 12.51%) to 14.00% (9.00%, 18.88%).
Conclusions
These findings suggest that higher adherence to PHD was associated with lower risk of total CVD, IHD, AF, and HF in populations across all genetic risk categories.
{"title":"Adherence to a planetary health diet, genetic susceptibility, and incident cardiovascular disease: a prospective cohort study from the UK Biobank","authors":"","doi":"10.1016/j.ajcnut.2024.06.014","DOIUrl":"10.1016/j.ajcnut.2024.06.014","url":null,"abstract":"<div><h3>Background</h3><p>The influence of adherence to a planetary health diet (PHD) proposed by the EAT-Lancet Commission on cardiovascular disease (CVD) is inconclusive. Besides, whether genetic susceptibility to CVD can modify the association of PHD with CVD remains unknown.</p></div><div><h3>Objective</h3><p>We aimed to investigate the association between adherence to PHD and CVD, and to evaluate the interaction between PHD and genetic predisposition to CVD.</p></div><div><h3>Methods</h3><p><span><span>This study included 114,165 participants who completed at least two 24-h dietary recalls and were initially free of CVD from the UK Biobank. PHD score was calculated to assess adherence to PHD. Genetic risk was evaluated using the polygenic risk score. Incidence of total CVD, </span>ischemic heart disease (IHD), </span>atrial fibrillation<span> (AF), heart failure (HF), and stroke were identified via electronic health records<span>. Cox proportional hazard regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).</span></span></p></div><div><h3>Results</h3><p>During a median follow-up of 9.9 y, 10,071 (8.8%) incident CVD cases were documented. Compared with participants with the lowest adherence to PHD, HRs (95% CIs) for total CVD, IHD, AF, HF, and stroke among those with the highest adherence were 0.79 (0.74, 0.84), 0.73 (0.67, 0.79), 0.90 (0.82, 0.99), 0.69 (0.59, 0.82), and 0.88 (0.75, 1.04), respectively. No significant interaction between the genetic risk of CVD and PHD was observed. Participants with high genetic risk and low PHD score, as compared with those with low genetic risk and high PHD score, had a 48% (95% CI: 40%, 56%) higher risk of CVD. The population-attributable risk (95% CI) of CVD for poor adherence to PHD ranged from 8.79% (5.36%, 12.51%) to 14.00% (9.00%, 18.88%).</p></div><div><h3>Conclusions</h3><p>These findings suggest that higher adherence to PHD was associated with lower risk of total CVD, IHD, AF, and HF in populations across all genetic risk categories.</p></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.ajcnut.2024.06.010
Background
Although high ultraprocessed food (UPF) consumption has been linked with increased mortality risk in the general population, whether UPFs harm participants with a history of cancer remains unclear.
Objectives
This study aimed to evaluate the association of UPF consumption with mortality among participants with a history of cancer.
Methods
Prospective cohort analysis was conducted on 13,640 participants with a history of cancer from the UK Biobank. UPFs were defined by the Nova classification. UPF consumption was calculated as the weight proportion of UPFs in the total food consumption. Cox proportional hazard models were used to assess the association between UPF consumption and mortality among participants with a history of cancer.
Results
The median UPF consumption was 29.25% (interquartile range [IQR]: 19.46%–40.62%) for males and 25.81% (IQR: 16.61%–36.35%) for females in the total diet among participants with a history of cancer. During a median follow-up of 10.77 years, 1611 deaths were documented. Multivariable-adjusted hazard ratios (95% confidence intervals) among participants in the highest quartile of UPF consumption relative to the lowest were 1.17 (1.02, 1.35) for all-cause mortality and 1.22 (1.03, 1.44) for cancer-related mortality.
Conclusions
Higher UPF consumption after the diagnosis among participants with a history of cancer is associated with higher risk of mortality.
{"title":"Associations of ultraprocessed food consumption with mortality among participants with a history of cancer: a prospective cohort analysis","authors":"","doi":"10.1016/j.ajcnut.2024.06.010","DOIUrl":"10.1016/j.ajcnut.2024.06.010","url":null,"abstract":"<div><h3>Background</h3><p>Although high ultraprocessed food (UPF) consumption has been linked with increased mortality risk in the general population, whether UPFs harm participants with a history of cancer remains unclear.</p></div><div><h3>Objectives</h3><p>This study aimed to evaluate the association of UPF consumption with mortality among participants with a history of cancer.</p></div><div><h3>Methods</h3><p><span>Prospective cohort analysis was conducted on 13,640 participants with a history of cancer from the </span>UK Biobank<span>. UPFs were defined by the Nova<span> classification. UPF consumption was calculated as the weight proportion of UPFs in the total food consumption. Cox proportional hazard models were used to assess the association between UPF consumption and mortality among participants with a history of cancer.</span></span></p></div><div><h3>Results</h3><p>The median UPF consumption was 29.25% (interquartile range [IQR]: 19.46%–40.62%) for males and 25.81% (IQR: 16.61%–36.35%) for females in the total diet among participants with a history of cancer. During a median follow-up of 10.77 years, 1611 deaths were documented. Multivariable-adjusted hazard ratios (95% confidence intervals) among participants in the highest quartile of UPF consumption relative to the lowest were 1.17 (1.02, 1.35) for all-cause mortality and 1.22 (1.03, 1.44) for cancer-related mortality.</p></div><div><h3>Conclusions</h3><p>Higher UPF consumption after the diagnosis among participants with a history of cancer is associated with higher risk of mortality.</p></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141472230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.ajcnut.2024.06.016
Background
Algae-derived nutraceuticals, such as spirulina, have been reported to have biological activities that may minimize clinical consequences to COVID-19 infections.
Objectives
This study aimed to determine whether spirulina is an effective treatment for high-risk patients with early COVID-19 in an outpatient setting.
Methods
The TOGETHER trial is a placebo-controlled, randomized, platform trial conducted in Brazil. Eligible participants were symptomatic adults with a positive rapid test for SARS-CoV-2 older than 50 y or with a known risk factor for disease severity. Patients were randomly assigned to receive placebo or spirulina (1 g twice daily for 14 d). The primary end point was hospitalization defined as either retention in a COVID-19 emergency setting for >6 h or transfer to tertiary hospital owing to COVID-19 at 28 d. Secondary outcomes included time-to-hospitalization, mortality, and adverse drug reactions. We used a Bayesian framework to compare spirulina with placebo.
Results
We recruited 1126 participants, 569 randomly assigned to spirulina and 557 to placebo. The median age was 49.0 y, and 65.3% were female. The primary outcome occurred in 11.2% in the spirulina group and 8.1% in the placebo group (odds ratio [OR]: 1.24; 95% credible interval: 0.84, 1.86). There were no differences in emergency department visit (OR: 1.21; 95% credible interval: 0.81, 1.83), nor time to symptom relief (hazard ratio: 0.90; 95% credible interval: 0.79, 1.03). Spirulina also not demonstrate important treatment effects in the prespecified subgroups defined by age, sex, BMI, days since symptom onset, or vaccination status.
Conclusions
Spirulina has no any clinical benefits as an outpatient therapy for COVID-19 compared with placebo with respect to reducing the retention in an emergency setting or COVID-19–related hospitalization. There are no differences between spirulina and placebo for other secondary outcomes.
This trial was registered at clinicaltrials.gov as NCT04727424.
{"title":"Effect of spirulina on risk of hospitalization among patients with COVID-19: the TOGETHER randomized trial","authors":"","doi":"10.1016/j.ajcnut.2024.06.016","DOIUrl":"10.1016/j.ajcnut.2024.06.016","url":null,"abstract":"<div><h3>Background</h3><p>Algae-derived nutraceuticals, such as spirulina, have been reported to have biological activities that may minimize clinical consequences to COVID-19 infections.</p></div><div><h3>Objectives</h3><p>This study aimed to determine whether spirulina is an effective treatment for high-risk patients with early COVID-19 in an outpatient setting.</p></div><div><h3>Methods</h3><p>The TOGETHER trial is a placebo-controlled, randomized, platform trial conducted in Brazil. Eligible participants were symptomatic adults with a positive rapid test for SARS-CoV-2 older than 50 y or with a known risk factor for disease severity. Patients were randomly assigned to receive placebo or spirulina (1 g twice daily for 14 d). The primary end point was hospitalization defined as either retention in a COVID-19 emergency setting for >6 h or transfer to tertiary hospital owing to COVID-19 at 28 d. Secondary outcomes included time-to-hospitalization, mortality, and adverse drug reactions. We used a Bayesian framework to compare spirulina with placebo.</p></div><div><h3>Results</h3><p>We recruited 1126 participants, 569 randomly assigned to spirulina and 557 to placebo. The median age was 49.0 y, and 65.3% were female. The primary outcome occurred in 11.2% in the spirulina group and 8.1% in the placebo group (odds ratio [OR]: 1.24; 95% credible interval: 0.84, 1.86). There were no differences in emergency department visit (OR: 1.21; 95% credible interval: 0.81, 1.83), nor time to symptom relief (hazard ratio: 0.90; 95% credible interval: 0.79, 1.03). Spirulina also not demonstrate important treatment effects in the prespecified subgroups defined by age, sex, BMI, days since symptom onset, or vaccination status.</p></div><div><h3>Conclusions</h3><p>Spirulina has no any clinical benefits as an outpatient therapy for COVID-19 compared with placebo with respect to reducing the retention in an emergency setting or COVID-19–related hospitalization. There are no differences between spirulina and placebo for other secondary outcomes.</p><p>This trial was registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> as NCT04727424.</p></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142122352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.ajcnut.2024.06.008
Background
Maternal undernutrition is a direct risk factor for infant growth faltering.
Objectives
We evaluated the effect of postnatal balanced energy protein (BEP) supplementation in lactating women and azithromycin (AZ) in infants on infant growth outcomes.
Methods
A randomized controlled superiority trial of lactating mother–newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of <23 cm and live infants between 0 and 6 d of life were randomly assigned to 1 of 3 arms in a 1:1:1 ratio. Lactating mothers in the control arm received standard-of-care counseling on exclusive breastfeeding, nutrition, infant immunization, and health promotion plus iron-folate supplementation until the infant was 6 mo old. In intervention arm 1, mothers additionally received two 75-g sachets of BEP per day. In intervention arm 2, along with the standard-of-care and BEP to the mother, the infant also received 1 dose of azithromycin (20 mg/kg) at the age of 42 d . The primary outcome was infant length velocity at 6 mo. The total sample size was 957 (319 in each arm).
Results
From 1 August, 2018 to 19 May, 2020, 319 lactating mother–newborn dyads were randomly assigned in each arm, and the last follow-up was completed on 20 November, 2020. The mean difference in length velocity (cm/mo) between BEP alone and control was 0.01 (95% confidence interval [CI]: −0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI: 0.03, 0.13), and between BEP + AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) nonfatal events (injectable treatment and/or hospitalizations) were recorded.
Conclusions
Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 mo, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.
This trial was registered at clinicaltrials.gov as NCT03564652.
{"title":"Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial","authors":"","doi":"10.1016/j.ajcnut.2024.06.008","DOIUrl":"10.1016/j.ajcnut.2024.06.008","url":null,"abstract":"<div><h3>Background</h3><p>Maternal undernutrition is a direct risk factor for infant growth faltering.</p></div><div><h3>Objectives</h3><p>We evaluated the effect of postnatal balanced energy protein (BEP) supplementation in lactating women and azithromycin (AZ) in infants on infant growth outcomes.</p></div><div><h3>Methods</h3><p>A randomized controlled superiority trial of lactating mother–newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of <23 cm and live infants between 0 and 6 d of life were randomly assigned to 1 of 3 arms in a 1:1:1 ratio. Lactating mothers in the control arm received standard-of-care counseling on exclusive breastfeeding, nutrition, infant immunization, and health promotion plus iron-folate supplementation until the infant was 6 mo old. In intervention arm 1, mothers additionally received two 75-g sachets of BEP per day. In intervention arm 2, along with the standard-of-care and BEP to the mother, the infant also received 1 dose of azithromycin (20 mg/kg) at the age of 42 d . The primary outcome was infant length velocity at 6 mo. The total sample size was 957 (319 in each arm).</p></div><div><h3>Results</h3><p>From 1 August, 2018 to 19 May, 2020, 319 lactating mother–newborn dyads were randomly assigned in each arm, and the last follow-up was completed on 20 November, 2020. The mean difference in length velocity (cm/mo) between BEP alone and control was 0.01 (95% confidence interval [CI]: −0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI: 0.03, 0.13), and between BEP + AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) nonfatal events (injectable treatment and/or hospitalizations) were recorded.</p></div><div><h3>Conclusions</h3><p>Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 mo, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.</p><p>This trial was registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> as NCT03564652.</p></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":null,"pages":null},"PeriodicalIF":6.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002916524005422/pdfft?md5=e540365782939bfadf9d20373d41c186&pid=1-s2.0-S0002916524005422-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}