Undernutrition in adults increases mortality and impairs immunity and quality of life. Gut microbiota influences metabolism, suggesting potential for probiotic-based weight-gain strategies. This study aimed to assess the efficacy of a probiotic supplement combined with a weight-gain diet on anthropometric indices, appetite, and calorie intake in underweight adults. In this 8-week, double-blind, randomized, placebo-controlled trial, 95 underweight adults (aged 18-60 years) from Mashhad, Iran, were randomized to receive a probiotic supplement (Lacticaseibacillus rhamnosus GG, Lactobacillus acidophilus, Lacticaseibacillus casei; 109 CFU/capsule) or placebo with a 500-kcal surplus diet. Primary outcomes included anthropometric measures, including body weight and BMI. Secondary outcomes included appetite (via visual analog scales), caloric intake, and stool consistency. The probiotic group (n = 47) showed greater increases than the placebo group (n = 48) in body weight (2.41 vs 0.44 kg, p < 0.001), BMI (0.83 vs 0.24 kg/m², p < 0.001), body fat percentage (3.23% vs 1.03%, p < 0.001), fat mass (1.90 vs 0.89 kg, p = 0.002), and caloric intake (263.55 vs 30.75 kcal/day, p < 0.001). The probiotic group showed significant increases in hunger (p < 0.001) and desire to eat (p < 0.001), with reduced satiety and fullness before meals (p < 0.001), as assessed by VAS. Stool consistency in the probiotic group shifted significantly toward softer, more regular stools, as evidenced by a one-unit increase in the Bristol Stool Score (p = 0.01), compared to no change in the control group (p = 0.97). Probiotic supplementation with a weight-gain diet significantly enhances anthropometric measures, appetite, and calorie intake in underweight adults, offering a novel strategy for managing undernutrition.
Clinical trial registration: Iranian Registry of Clinical Trials, IRCT20230310057667N1 (Issue date 30 March 2023), https://irct.behdasht.gov.ir/trial/69130.
成人营养不良会增加死亡率,损害免疫力和生活质量。肠道菌群影响新陈代谢,提示基于益生菌的增重策略的潜力。本研究旨在评估益生菌补充剂结合增重饮食对体重过轻成人人体测量指标、食欲和卡路里摄入的影响。在这项为期8周的双盲、随机、安慰剂对照试验中,来自伊朗马什哈德的95名体重不足的成年人(18-60岁)被随机分为两组,一组接受益生菌补充剂(鼠李糖乳杆菌GG、嗜酸乳杆菌、干酪乳杆菌;109 CFU/胶囊),另一组接受500千卡剩余饮食的安慰剂。主要结局包括人体测量指标,包括体重和BMI。次要结果包括食欲(通过视觉模拟量表)、热量摄入和大便一致性。益生菌组(n = 47)在体重(2.41 vs 0.44 kg, p < 0.001)、BMI (0.83 vs 0.24 kg/m²,p < 0.001)、体脂率(3.23% vs 1.03%, p < 0.001)、脂肪量(1.90 vs 0.89 kg, p = 0.002)和热量摄入(263.55 vs 30.75 kcal/d, p < 0.001)方面均比安慰剂组(n = 48)有更大的增加。根据VAS评估,益生菌组的饥饿感(p < 0.001)和食欲(p < 0.001)显著增加,餐前饱腹感和饱腹感降低(p < 0.001)。与对照组没有变化(p = 0.97)相比,益生菌组的粪便稠度明显转向更柔软、更规律的粪便,布里斯托尔粪便评分增加了一个单位(p = 0.01)就是证据。在体重增加的饮食中补充益生菌可以显著提高体重不足的成年人的人体测量、食欲和卡路里摄入量,为治疗营养不良提供了一种新的策略。临床试验注册:伊朗临床试验注册中心,IRCT20230310057667N1(发布日期2023年3月30日),https://irct.behdasht.gov.ir/trial/69130。
{"title":"Effects of a Novel Probiotic Supplement with Weight Gain Intervention on Anthropometry, Body Composition, and Appetite in Underweight Adults: A Randomized Controlled Trial.","authors":"Alireza Hatami, Maryam Ahmadi-Khorram, Reza Rahmanian, Ali Jafarzadeh Esfehani, Elyas Nattagh-Eshtivani, Asma Afshari, Mohsen Nematy","doi":"10.1080/19390211.2025.2561132","DOIUrl":"10.1080/19390211.2025.2561132","url":null,"abstract":"<p><p>Undernutrition in adults increases mortality and impairs immunity and quality of life. Gut microbiota influences metabolism, suggesting potential for probiotic-based weight-gain strategies. This study aimed to assess the efficacy of a probiotic supplement combined with a weight-gain diet on anthropometric indices, appetite, and calorie intake in underweight adults. In this 8-week, double-blind, randomized, placebo-controlled trial, 95 underweight adults (aged 18-60 years) from Mashhad, Iran, were randomized to receive a probiotic supplement (Lacticaseibacillus rhamnosus GG, Lactobacillus acidophilus, Lacticaseibacillus casei; 10<sup>9</sup> CFU/capsule) or placebo with a 500-kcal surplus diet. Primary outcomes included anthropometric measures, including body weight and BMI. Secondary outcomes included appetite (via visual analog scales), caloric intake, and stool consistency. The probiotic group (n = 47) showed greater increases than the placebo group (n = 48) in body weight (2.41 vs 0.44 kg, p < 0.001), BMI (0.83 vs 0.24 kg/m², p < 0.001), body fat percentage (3.23% vs 1.03%, p < 0.001), fat mass (1.90 vs 0.89 kg, p = 0.002), and caloric intake (263.55 vs 30.75 kcal/day, p < 0.001). The probiotic group showed significant increases in hunger (p < 0.001) and desire to eat (p < 0.001), with reduced satiety and fullness before meals (p < 0.001), as assessed by VAS. Stool consistency in the probiotic group shifted significantly toward softer, more regular stools, as evidenced by a one-unit increase in the Bristol Stool Score (p = 0.01), compared to no change in the control group (p = 0.97). Probiotic supplementation with a weight-gain diet significantly enhances anthropometric measures, appetite, and calorie intake in underweight adults, offering a novel strategy for managing undernutrition.</p><p><p><b>Clinical trial registration:</b> Iranian Registry of Clinical Trials, IRCT20230310057667N1 (Issue date 30 March 2023), https://irct.behdasht.gov.ir/trial/69130.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"958-976"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-04-01DOI: 10.1080/19390211.2024.2335573
Alexander J Layman, Scott M Alsbrook, Igor K Koturbash, Mitchell R McGill
Acetaminophen (APAP) overdose is one of the most common causes of acute liver injury. The current standard-of-care treatment for APAP hepatotoxicity, N-acetyl-l-cysteine, is highly effective when administered early after overdose, but loses efficacy in later-presenting patients. As a result, there is interest in the identification of new treatments for APAP overdose patients. Natural products are a promising source of new treatments because many are purported to have hepatoprotective effects. In fact, a great deal of research has been done to identify natural products that can protect against APAP-induced liver injury. However, serious concerns have been raised about the rigor and human relevance of these studies. Here, we systematically reviewed the APAP-natural product literature from 2013 to 2023 to determine the veracity of these concerns and the scope of the potential problem. The results substantiate the concerns that have been previously raised and point to concrete steps that can be taken to improve APAP-natural product research.
{"title":"Natural Products That Protect Against Acetaminophen Hepatotoxicity: A Call for Increased Rigor in Preclinical Studies of Dietary Supplements.","authors":"Alexander J Layman, Scott M Alsbrook, Igor K Koturbash, Mitchell R McGill","doi":"10.1080/19390211.2024.2335573","DOIUrl":"10.1080/19390211.2024.2335573","url":null,"abstract":"<p><p>Acetaminophen (APAP) overdose is one of the most common causes of acute liver injury. The current standard-of-care treatment for APAP hepatotoxicity, <i>N</i>-acetyl-<i>l</i>-cysteine, is highly effective when administered early after overdose, but loses efficacy in later-presenting patients. As a result, there is interest in the identification of new treatments for APAP overdose patients. Natural products are a promising source of new treatments because many are purported to have hepatoprotective effects. In fact, a great deal of research has been done to identify natural products that can protect against APAP-induced liver injury. However, serious concerns have been raised about the rigor and human relevance of these studies. Here, we systematically reviewed the APAP-natural product literature from 2013 to 2023 to determine the veracity of these concerns and the scope of the potential problem. The results substantiate the concerns that have been previously raised and point to concrete steps that can be taken to improve APAP-natural product research.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"105-122"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11442681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140335846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-10-25DOI: 10.1080/19390211.2024.2419434
Taylor C Wallace, Igor Koturbash
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA's statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as 'outdated' regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction.
{"title":"DSHEA 1994 - Celebrating 30 Years of Dietary Supplement Regulation in the United States.","authors":"Taylor C Wallace, Igor Koturbash","doi":"10.1080/19390211.2024.2419434","DOIUrl":"10.1080/19390211.2024.2419434","url":null,"abstract":"<p><p>The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA's statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as 'outdated' regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"1-8"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142501632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-01-08DOI: 10.1080/19390211.2024.2449023
Michelle Gimbar, Hamed Samavat, Kristen P Hamilton, Jane Ziegler, Floris Wardenaar, Carrie Esopenko, Laura Byham-Gray
Nutritional supplements (NS) are linked to adverse events and unintentional doping among college-athletes. The use of third-party tested (TPT) NS can increase safety and reduce the risk of inadvertent consumption of banned substances. The purpose of this study was to examine self-reported use of TPT supplements between the National Collegiate Athletic Association (NCAA) Division I (DI) and Division III (DIII) college-athletes and explore the potential predictors of TPT use. This cross-sectional study used data from a web-based, 50-question survey on supplement use, behaviors, and knowledge. A total of 271 individuals completed the survey, 118 athletes (66.9% DI, 33.1% DIII) were included in the analysis due to completion of TPT NS questions. Among this sample, 80.5% of student-athletes reported use of TPT NS, however, only 17.8% of students reported consistent use of TPT NS. In the multivariable model adjusted for athletic division, sex, and sport-type, student-athletes who preferred information from a strength and conditioning coach or athletic trainer were 69% less likely to report consistent use of TPT NS across all categories when compared to those who preferred going to a registered dietitian nutritionist (RDN). Student-athletes with limited access to an RD/RDN were more likely to use an athletic trainer or strength and conditioning coach for supplement information. Having dedicated RDNs within athletic departments may benefit athletes when it comes to safe NS use. Programs should also consider additional supplement education to athletic trainers and strength and conditioning coaches to help ensure safe and effective use of NS.
{"title":"Predictors of Third-Party Tested Nutritional Supplementation Use Among DI and DIII Student-Athletes at A Northeast University.","authors":"Michelle Gimbar, Hamed Samavat, Kristen P Hamilton, Jane Ziegler, Floris Wardenaar, Carrie Esopenko, Laura Byham-Gray","doi":"10.1080/19390211.2024.2449023","DOIUrl":"10.1080/19390211.2024.2449023","url":null,"abstract":"<p><p>Nutritional supplements (NS) are linked to adverse events and unintentional doping among college-athletes. The use of third-party tested (TPT) NS can increase safety and reduce the risk of inadvertent consumption of banned substances. The purpose of this study was to examine self-reported use of TPT supplements between the National Collegiate Athletic Association (NCAA) Division I (DI) and Division III (DIII) college-athletes and explore the potential predictors of TPT use. This cross-sectional study used data from a web-based, 50-question survey on supplement use, behaviors, and knowledge. A total of 271 individuals completed the survey, 118 athletes (66.9% DI, 33.1% DIII) were included in the analysis due to completion of TPT NS questions. Among this sample, 80.5% of student-athletes reported use of TPT NS, however, only 17.8% of students reported consistent use of TPT NS. In the multivariable model adjusted for athletic division, sex, and sport-type, student-athletes who preferred information from a strength and conditioning coach or athletic trainer were 69% less likely to report consistent use of TPT NS across all categories when compared to those who preferred going to a registered dietitian nutritionist (RDN). Student-athletes with limited access to an RD/RDN were more likely to use an athletic trainer or strength and conditioning coach for supplement information. Having dedicated RDNs within athletic departments may benefit athletes when it comes to safe NS use. Programs should also consider additional supplement education to athletic trainers and strength and conditioning coaches to help ensure safe and effective use of NS.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"310-328"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-08-01DOI: 10.1080/19390211.2025.2533889
M Ashwini, Ajit Antony, H S Shilpa, S V V S Ravi Mangu, Kunal Sharan, Mukesh Kapoor
Gut dysbiosis is a key feature in ulcerative colitis, a globally prevalent subtype of inflammatory bowel disease. Microbiota-directed dietary supplements can restore the dysbiotic gut and alleviate ulcerative colitis. We aimed to delineate whether prebiotic guar gum β-manno-oligosaccharides [GG-β-MOS(i) 500 mg/kg, (ii) 1000 mg/kg] favors gut microflora and microflora associated characteristics (MACs) and can prevent dextran sodium sulfate (DSS) induced ulcerative colitis in mice model. DSS challenged adult male C57BL/6 mice were used as model for colon inflammation evaluation. Food and water consumption, disease activity index (DAI), histopathological changes, cytokines in sera and colonic tissues, microflora associated characteristics (MACs; post-fermentation metabolites, short-chain fatty acids, etc.) and gut microflora profiles were studied. We found that GG-β-MOS successfully attenuated colonic inflammation, reduced inflammatory proteins, improved the ratio of Firmicutes to Bacteroidetes and promoted the colonization of probiotics like Lactobacillus and Bifidobacteria. Furthermore, GG-β-MOS enriched beneficial bacteria viz., Lactobacillus, Bifidobacteria, Bacillus and Enterococcus showed positive correlation with anti-inflammatory metabolites like D-mannose, coprostanol, pentadecane, alpha-linolenic acid, dihomo-γ-linolenic acid, D-ribose, L-fucose, D-arabinose, N-acetyl-D-glucosamine, acetate and butyrate and negative correlation with oxalate, palmitic acid, arachidonic acid and erythritol. Overall, GG-β-MOS supplementation restored altered gut microflora and metabolome leading to improved mucosal repair and reduced intestinal inflammation in DSS induced ulcerative colitis mice model.
肠道生态失调是溃疡性结肠炎的一个关键特征,溃疡性结肠炎是一种全球流行的炎症性肠病亚型。以微生物群为导向的膳食补充剂可以恢复肠道的益生菌失调,减轻溃疡性结肠炎。我们旨在确定益生元瓜尔胶β-甘露寡糖[GG-β-MOS(i) 500 mg/kg, (ii) 1000 mg/kg]是否有利于肠道微生物群和微生物群相关特征(MACs),并可以预防小鼠模型中葡聚糖硫酸钠(DSS)诱导的溃疡性结肠炎。以DSS攻激的成年雄性C57BL/6小鼠为模型进行结肠炎症评价。食物和水的消耗、疾病活动指数(DAI)、组织病理学变化、血清和结肠组织中的细胞因子、微生物群相关特征(MACs);研究了发酵后代谢产物、短链脂肪酸等)和肠道菌群特征。我们发现GG-β-MOS成功地减轻了结肠炎症,降低了炎症蛋白,提高了厚壁菌门与拟杆菌门的比例,促进了乳酸杆菌和双歧杆菌等益生菌的定植。此外,GG-β- mos富集有益菌、乳杆菌、双歧杆菌、芽孢杆菌和肠球菌与d -甘露糖、coprostanol、pentadecane、α -亚麻酸、二homo-γ-亚麻酸、d -核糖、L-焦糖、d -阿拉伯糖、n -乙酰- d -葡萄糖胺、乙酸和丁酸呈正相关,与草酸、棕榈酸、花生四烯酸和赤藓糖醇呈负相关。总体而言,在DSS诱导的溃疡性结肠炎小鼠模型中,补充GG-β-MOS可以恢复改变的肠道菌群和代谢组,从而改善粘膜修复并减少肠道炎症。
{"title":"Guar Gum β-Manno-Oligosaccharides Alleviate Ulcerative Colitis in Mice Models <i>via</i> Gut Microflora Modulation.","authors":"M Ashwini, Ajit Antony, H S Shilpa, S V V S Ravi Mangu, Kunal Sharan, Mukesh Kapoor","doi":"10.1080/19390211.2025.2533889","DOIUrl":"10.1080/19390211.2025.2533889","url":null,"abstract":"<p><p>Gut dysbiosis is a key feature in ulcerative colitis, a globally prevalent subtype of inflammatory bowel disease. Microbiota-directed dietary supplements can restore the dysbiotic gut and alleviate ulcerative colitis. We aimed to delineate whether prebiotic guar gum β-manno-oligosaccharides [GG-β-MOS(i) 500 mg/kg, (ii) 1000 mg/kg] favors gut microflora and microflora associated characteristics (MACs) and can prevent dextran sodium sulfate (DSS) induced ulcerative colitis in mice model. DSS challenged adult male C57BL/6 mice were used as model for colon inflammation evaluation. Food and water consumption, disease activity index (DAI), histopathological changes, cytokines in sera and colonic tissues, microflora associated characteristics (MACs; post-fermentation metabolites, short-chain fatty acids, etc.) and gut microflora profiles were studied. We found that GG-β-MOS successfully attenuated colonic inflammation, reduced inflammatory proteins, improved the ratio of Firmicutes to Bacteroidetes and promoted the colonization of probiotics like <i>Lactobacillus</i> and <i>Bifidobacteria</i>. Furthermore, GG-β-MOS enriched beneficial bacteria <i>viz.</i>, <i>Lactobacillus</i>, <i>Bifidobacteria</i>, <i>Bacillus</i> and <i>Enterococcus</i> showed positive correlation with anti-inflammatory metabolites like D-mannose, coprostanol, pentadecane, alpha-linolenic acid, dihomo-γ-linolenic acid, D-ribose, L-fucose, D-arabinose, N-acetyl-D-glucosamine, acetate and butyrate and negative correlation with oxalate, palmitic acid, arachidonic acid and erythritol. Overall, GG-β-MOS supplementation restored altered gut microflora and metabolome leading to improved mucosal repair and reduced intestinal inflammation in DSS induced ulcerative colitis mice model.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"750-774"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144760233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This retrospective study examines dietary supplement recalls in Greece from 2015 to 2024, focusing on seasonal trends, reasons for recalls, and dosage forms. A total of 602 recalls were analyzed, with sexual enhancement products (39%), weight management supplements (21%), and bodybuilding supplements (10%) representing the majority of cases. Recalls were primarily attributed to adulterants (62%), quality control issues (15%), and violations related to novel food ingredients (9%). The most commonly recalled dosage forms were capsules (56%) and powders (16%). Capsules and powders are prevalent due to their cost-effective manufacturing processes and simpler formulation requirements, while notable was the presence of honeys and pastes which often appeal to consumers seeking 'natural' remedies. Products sold exclusively online accounted for 63% of recalls, highlighting the risks associated with unregulated e-commerce channels. Seasonal patterns revealed increasing trends in recalls during winter, attributed to consumer demand and regulatory focus. The three major product categories showed seasonal trends, though these were not statistically significant. Specifically, sexual dysfunction products exhibited seasonal variation, with peaks in January and April associated with adulterants such as sildenafil and tadalafil. Weight management product recalls were higher in January and December, reflecting post-holiday and pre-New Year health trends, while bodybuilding supplements showed steady activity with slight increases in late summer. These findings underscore the importance of targeted regulatory enforcement during high-risk periods, enhanced consumer awareness campaigns, and strengthened international collaboration to address safety violations. Special attention to online marketplaces and tailored strategies addressing specific product categories and dosage forms are critical to improving public health outcomes and supplement safety.
{"title":"Trends, Patterns, and Public Health Implications of Dietary Supplement Recalls: A Decade-Long Analysis from the Greek National Organization for Medicines (2015-2024).","authors":"Athanasios Skouras, Minas Μ Stylianakis, Vasileios Tzatzadakis, Emmanouela Magripli, Apostolos Vantarakis, Evangelia E Ntzani","doi":"10.1080/19390211.2025.2529844","DOIUrl":"10.1080/19390211.2025.2529844","url":null,"abstract":"<p><p>This retrospective study examines dietary supplement recalls in Greece from 2015 to 2024, focusing on seasonal trends, reasons for recalls, and dosage forms. A total of 602 recalls were analyzed, with sexual enhancement products (39%), weight management supplements (21%), and bodybuilding supplements (10%) representing the majority of cases. Recalls were primarily attributed to adulterants (62%), quality control issues (15%), and violations related to novel food ingredients (9%). The most commonly recalled dosage forms were capsules (56%) and powders (16%). Capsules and powders are prevalent due to their cost-effective manufacturing processes and simpler formulation requirements, while notable was the presence of honeys and pastes which often appeal to consumers seeking 'natural' remedies. Products sold exclusively online accounted for 63% of recalls, highlighting the risks associated with unregulated e-commerce channels. Seasonal patterns revealed increasing trends in recalls during winter, attributed to consumer demand and regulatory focus. The three major product categories showed seasonal trends, though these were not statistically significant. Specifically, sexual dysfunction products exhibited seasonal variation, with peaks in January and April associated with adulterants such as sildenafil and tadalafil. Weight management product recalls were higher in January and December, reflecting post-holiday and pre-New Year health trends, while bodybuilding supplements showed steady activity with slight increases in late summer. These findings underscore the importance of targeted regulatory enforcement during high-risk periods, enhanced consumer awareness campaigns, and strengthened international collaboration to address safety violations. Special attention to online marketplaces and tailored strategies addressing specific product categories and dosage forms are critical to improving public health outcomes and supplement safety.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"722-749"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-06-23DOI: 10.1080/19390211.2025.2522463
Vishal P Dubey, Jignesh J Kansagra, Varun P Sureja, Dharmeshkumar B Kheni
Insulin resistance leads to increased glucose and insulin levels. Probiotics can reduce insulin resistance, but the presence of different probiotic strains and doses prevents the generalization to real-world scenario. The current systematic review and meta-analysis study investigated the efficacy of a triple probiotic combination (Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum) on glycemic index and insulin resistance parameters in adults. Randomized controlled trials evaluating the efficacy of the probiotics combination on glycemic index and insulin resistance parameters were identified. Physiotherapy Evidence Database scale and the Cochrane Risk of Bias tool were used for risk of bias assessment and RevMan for meta-analysis. Fourteen good-quality clinical trials were included in the current study. Low-to-moderate risk of bias was observed. Data from 823 participants were included. Probiotics supplementation significantly reduced insulin resistance (MD: -1.05 HOMA-IR score, p < 0.00001), serum glucose (MD: -3.99 mg/dl, p = 0.0003) and insulin levels (MD: -3.79 µIU/ml, p < 0.00001), while significantly improved insulin sensitivity (MD: +0.02 QUICKI score, p < 0.00001) and pancreatic β-cell functioning (MD: -14.71 HOMA-B score, p < 0.00001) compared to the control group. Significant heterogeneity was observed for all evaluation parameters (except the HOMA-B score) while no significant publication bias was observed. The current study suggests that the probiotic combination of Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum is effective in reducing insulin resistance, improving glycemic index parameters, and improving pancreatic β-cell functioning in adults by improving the gastrointestinal microbiome.
{"title":"Efficacy of a Probiotic Combination on Glycemic Index and Insulin Resistance in Adults: A Systematic Review and Meta-Analysis.","authors":"Vishal P Dubey, Jignesh J Kansagra, Varun P Sureja, Dharmeshkumar B Kheni","doi":"10.1080/19390211.2025.2522463","DOIUrl":"10.1080/19390211.2025.2522463","url":null,"abstract":"<p><p>Insulin resistance leads to increased glucose and insulin levels. Probiotics can reduce insulin resistance, but the presence of different probiotic strains and doses prevents the generalization to real-world scenario. The current systematic review and meta-analysis study investigated the efficacy of a triple probiotic combination (<i>Lactobacillus acidophilus</i>, <i>Lactobacillus casei</i>, and <i>Bifidobacterium bifidum</i>) on glycemic index and insulin resistance parameters in adults. Randomized controlled trials evaluating the efficacy of the probiotics combination on glycemic index and insulin resistance parameters were identified. Physiotherapy Evidence Database scale and the Cochrane Risk of Bias tool were used for risk of bias assessment and RevMan for meta-analysis. Fourteen good-quality clinical trials were included in the current study. Low-to-moderate risk of bias was observed. Data from 823 participants were included. Probiotics supplementation significantly reduced insulin resistance (MD: -1.05 HOMA-IR score, <i>p</i> < 0.00001), serum glucose (MD: -3.99 mg/dl, <i>p</i> = 0.0003) and insulin levels (MD: -3.79 µIU/ml, <i>p</i> < 0.00001), while significantly improved insulin sensitivity (MD: +0.02 QUICKI score, <i>p</i> < 0.00001) and pancreatic β-cell functioning (MD: -14.71 HOMA-B score, <i>p</i> < 0.00001) compared to the control group. Significant heterogeneity was observed for all evaluation parameters (except the HOMA-B score) while no significant publication bias was observed. The current study suggests that the probiotic combination of <i>Lactobacillus acidophilus</i>, <i>Lactobacillus casei</i>, and <i>Bifidobacterium bifidum</i> is effective in reducing insulin resistance, improving glycemic index parameters, and improving pancreatic β-cell functioning in adults by improving the gastrointestinal microbiome.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"641-663"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144475499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-04-12DOI: 10.1080/19390211.2025.2488811
Joel Puente-Fernández, Eneko Larumbe-Zabala, Justin Roberts, Fernando Naclerio
The aim of the current parallel randomized controlled trial was to compare the effects of ingesting a dietary supplement admixture providing carbohydrates, leucine-fortified whey protein, creatine, β-hydroxy-β-methylbutyrate, and vitamin D3 (Master Recovery 1:1, Crown Sport Nutrition, Spain), versus an isoenergetic carbohydrate-only comparator on body composition, muscle thickness, muscle strength, and performance over a 6-week resistance training program, performed three times per week, in aging, physically active individuals. Twenty participants (10 peri- and post-menopausal females and 10 males) -completed the study after being randomly assigned to one of the following groups: post-workout multi-ingredient (PWS: n = 10, 52.0 ± 5 years, body mass 82.0 ± 18.0 kg) or a comparator (COM: n = 10, 51 ± 3 years, body mass 85.9 ± 17.0 kg). Treatment consisted of ingesting 60.0 g of the assigned supplement immediately after each workout. Compared to baseline, only PWS increased fat-free mass (+1.34 ± 1.2 kg, p = 0.003), reduced fat mass (-1.09 ± 0.7 kg, p < 0.001), waist circumference (-2.5 ± 1.8 cm, p < 0.001), and waist-to-hip ratio (-0.03 ± 0.03 cm, p = 0.007). At post-intervention, waist circumference reduction was different between groups (p = 0.02, d = 1.19). Both treatments similarly improved vastus lateralis and elbow flexor thickness, medicine ball throw, and endurance performance. Although countermovement jump improved for both treatments, the PWS group showed a significantly higher performance increase compared to COM (p < 0.01, d = 1.47). Compared to ingesting carbohydrates only, the use of a targeted multi-ingredient promoted noticeable body composition outcomes and better vertical jump improvements with no further effects on hypertrophy, upper body, and endurance performance. The study was registered as a clinical trial at ClinicalTrials.gov (NCT05769088).
目前的平行随机对照试验的目的是比较摄入一种膳食补充剂混合物提供碳水化合物、增强型乳清蛋白、肌酸、β-羟基-β-甲基丁酸盐和维生素D3的影响(Master Recovery 1:1, Crown Sport Nutrition,西班牙),与只摄入等能碳水化合物的比较物在身体组成、肌肉厚度、肌肉力量和表现方面的影响,在为期6周的阻力训练计划中,每周进行三次。在老年人中,身体活跃的人。20名参与者(10名绝经前后女性和10名男性)在被随机分配到以下一组后完成了研究:运动后多成分组(PWS: n = 10, 52.0±5岁,体重82.0±18.0 kg)或比较组(COM: n = 10, 51±3岁,体重85.9±17.0 kg)。治疗包括在每次锻炼后立即摄入60.0 g指定的补充剂。与基线相比,只有PWS增加了无脂质量(+1.34±1.2 kg, p = 0.003),减少脂肪质量(-1.09±0.7 kg, p p = 0.007)。干预后,两组腰围缩小差异有统计学意义(p = 0.02, d = 1.19)。两种治疗方法同样改善了股外侧肌和肘关节屈肌厚度、实心球投掷和耐力表现。虽然两种处理都改善了反向运动跳跃,但PWS组的性能提高明显高于COM组(p d = 1.47)。与只摄入碳水化合物相比,使用有针对性的多种成分促进了显著的身体组成结果和更好的垂直跳跃改善,而对肥厚、上半身和耐力表现没有进一步的影响。该研究已在ClinicalTrials.gov注册为临床试验(NCT05769088)。
{"title":"Effect of a Multi-Ingredient Post-Workout Dietary Supplement on Body Composition and Muscle Strength - A Randomized Controlled Trial.","authors":"Joel Puente-Fernández, Eneko Larumbe-Zabala, Justin Roberts, Fernando Naclerio","doi":"10.1080/19390211.2025.2488811","DOIUrl":"https://doi.org/10.1080/19390211.2025.2488811","url":null,"abstract":"<p><p>The aim of the current parallel randomized controlled trial was to compare the effects of ingesting a dietary supplement admixture providing carbohydrates, leucine-fortified whey protein, creatine, <i>β</i>-hydroxy-<i>β</i>-methylbutyrate, and vitamin D3 (Master Recovery 1:1, Crown Sport Nutrition, Spain), versus an isoenergetic carbohydrate-only comparator on body composition, muscle thickness, muscle strength, and performance over a 6-week resistance training program, performed three times per week, in aging, physically active individuals. Twenty participants (10 peri- and post-menopausal females and 10 males) -completed the study after being randomly assigned to one of the following groups: post-workout multi-ingredient (PWS: <i>n</i> = 10, 52.0 ± 5 years, body mass 82.0 ± 18.0 kg) or a comparator (COM: <i>n</i> = 10, 51 ± 3 years, body mass 85.9 ± 17.0 kg). Treatment consisted of ingesting 60.0 g of the assigned supplement immediately after each workout. Compared to baseline, only PWS increased fat-free mass (+1.34 ± 1.2 kg, <i>p</i> = 0.003), reduced fat mass (-1.09 ± 0.7 kg, <i>p</i> < 0.001), waist circumference (-2.5 ± 1.8 cm, <i>p</i> < 0.001), and waist-to-hip ratio (-0.03 ± 0.03 cm, <i>p</i> = 0.007). At post-intervention, waist circumference reduction was different between groups (<i>p</i> = 0.02, <i>d</i> = 1.19). Both treatments similarly improved vastus lateralis and elbow flexor thickness, medicine ball throw, and endurance performance. Although countermovement jump improved for both treatments, the PWS group showed a significantly higher performance increase compared to COM (<i>p</i> < 0.01, <i>d</i> = 1.47). Compared to ingesting carbohydrates only, the use of a targeted multi-ingredient promoted noticeable body composition outcomes and better vertical jump improvements with no further effects on hypertrophy, upper body, and endurance performance. The study was registered as a clinical trial at ClinicalTrials.gov (NCT05769088).</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":"22 3","pages":"445-462"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Data on a mushroom based prebiotic supplementation in patients with Crohn's disease (CD) in western population is scarce. In this pilot trial, we aimed to assess the clinical efficacy and fecal microbial compositional and functional alterations associated with 'Mycodigest,' a commercial prebiotic supplement composed of three mushroom extracts. Patients with mild to moderate CD were recruited to a single center, randomized, double-blind, placebo-controlled pilot induction trial. Clinical efficacy using the Harvey-Bradshaw index and biochemical response using C-reactive protein and fecal calprotectin were assessed at week 8 post-intervention. Fecal samples were assessed by DNA shotgun metagenomic sequencing. A multivariable linear mixed effects model was used to assess alteration in fecal microbiome composition and function pre- and post-'Mycodigest' intervention. Clinical response was higher in the 'Mycodigest' intervention (N = 10) compared to the placebo (N = 6) group (80 vs. 16.7%, respectively, p = 0.035). There were no differences in terms of biochemical response within each group pre- and post-intervention. Post-'Mycodigest' intervention, 25 species were found to be differentially abundant compared to baseline, including increase in short chain fatty acid producing bacteria, such as Parabacteroides distasonis (Beta coefficient 0.92, 95% Confidence interval [CI] 0.36-1.47) and Faecalimonas umbilicata (Beta coefficient 0.57, 95% CI 0.23-0.90). Two microbial pathways related to the metabolism of isoprenoid compounds were increased post-'Mycodigest' intervention. Mushroom based prebiotic supplementation in subjects with CD resulted in clinical improvement which may be related to post-intervention favorable compositional and functional microbial alterations.
{"title":"A Mushroom Based Prebiotic Supplement Pilot Study Among Patients with Crohn's Disease.","authors":"Haim Leibovitzh, Naomi Fliss Isakov, Lael Werner, Tamar Thurm, Ayal Hirsch, Nathaniel Aviv Cohen, Nitsan Maharshak","doi":"10.1080/19390211.2025.2498127","DOIUrl":"10.1080/19390211.2025.2498127","url":null,"abstract":"<p><p>Data on a mushroom based prebiotic supplementation in patients with Crohn's disease (CD) in western population is scarce. In this pilot trial, we aimed to assess the clinical efficacy and fecal microbial compositional and functional alterations associated with 'Mycodigest,' a commercial prebiotic supplement composed of three mushroom extracts. Patients with mild to moderate CD were recruited to a single center, randomized, double-blind, placebo-controlled pilot induction trial. Clinical efficacy using the Harvey-Bradshaw index and biochemical response using C-reactive protein and fecal calprotectin were assessed at week 8 post-intervention. Fecal samples were assessed by DNA shotgun metagenomic sequencing. A multivariable linear mixed effects model was used to assess alteration in fecal microbiome composition and function pre- and post-'Mycodigest' intervention. Clinical response was higher in the 'Mycodigest' intervention (<i>N</i> = 10) compared to the placebo (<i>N</i> = 6) group (80 <i>vs.</i> 16.7%, respectively, <i>p</i> = 0.035). There were no differences in terms of biochemical response within each group pre- and post-intervention. Post-'Mycodigest' intervention, 25 species were found to be differentially abundant compared to baseline, including increase in short chain fatty acid producing bacteria, such as <i>Parabacteroides distasonis</i> (Beta coefficient 0.92, 95% Confidence interval [CI] 0.36-1.47) and <i>Faecalimonas umbilicata</i> (Beta coefficient 0.57, 95% CI 0.23-0.90). Two microbial pathways related to the metabolism of isoprenoid compounds were increased post-'Mycodigest' intervention. Mushroom based prebiotic supplementation in subjects with CD resulted in clinical improvement which may be related to post-intervention favorable compositional and functional microbial alterations.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"511-524"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144020785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}