R T Mankowski, K T Sibille, C Leeuwenburgh, Y Lin, F-C Hsu, P Qiu, B Sandesara, S D Anton
{"title":"Effects of Curcumin C3 Complex® on Physical Function in Moderately Functioning Older Adults with Low-Grade Inflammation - A Pilot Trial.","authors":"R T Mankowski, K T Sibille, C Leeuwenburgh, Y Lin, F-C Hsu, P Qiu, B Sandesara, S D Anton","doi":"10.14283/jfa.2022.47","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Natural dietary compounds that can modulate the inflammation process have the potential to improve physical function through a number of biological pathways, and thus may represent an alternative approach to avert functional decline compared to more time-burdening lifestyle interventions. In this pilot trial, we tested the feasibility and explored the effect of a nutritional compound, Curcumin C3 Complex® for improving physical function and muscle strength in moderately functioning older adults with low-grade inflammation.</p><p><strong>Methods: </strong>Moderately functioning (short physical performance battery, SPPB <10) and sedentary older adults (>65 years) with low-grade systemic inflammation (c-reactive protein >1mg/dL) were randomized to receive Curcumin C3 Complex® (n=9) (1000mg/day) or placebo (n=8) groups for 12 weeks. All participants (age range: 66-94 years, 8 females and 9 males) underwent functional testing (SPPB and walking speed by the 400-meter walk test) and lower-limb strength (knee flexion and extension peak torque by the Biodex test) at baseline and 12 weeks. Venous blood was collected at baseline, 4, 8 and 12 weeks for safety blood chemistry analyses and biomarkers of inflammation.</p><p><strong>Results: </strong>A total of 17 participants were randomized and completed the study. Adherence was high (> 90%) and there were no adverse events reported or abnormal blood chemistries reported. Based on effect sizes, participants in the Curcumin C3 Complex® group demonstrated large effect sizes in the SPPB (Cohen's effect size d=0.75) and measures of knee extension (d=0.69) and flexion peak torque (d=0.82). Effect sizes for galectin-3 (d=-0.31) (larger decrease) and interleukin-6 (d=0.38) (smaller increase) were small in the Curcumin C3 Complex® group compared to placebo.</p><p><strong>Conclusion: </strong>This pilot trial suggests that there were no difficulties with recruitment, adherence and safety specific to the study protocol. Preliminary findings warrant a Phase IIb clinical trial to test the effect of Curcumin C3 Complex® on physical function and muscle strength in older adults at risk for mobility disability.</p>","PeriodicalId":51629,"journal":{"name":"Journal of Frailty & Aging","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Frailty & Aging","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14283/jfa.2022.47","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GERIATRICS & GERONTOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Natural dietary compounds that can modulate the inflammation process have the potential to improve physical function through a number of biological pathways, and thus may represent an alternative approach to avert functional decline compared to more time-burdening lifestyle interventions. In this pilot trial, we tested the feasibility and explored the effect of a nutritional compound, Curcumin C3 Complex® for improving physical function and muscle strength in moderately functioning older adults with low-grade inflammation.
Methods: Moderately functioning (short physical performance battery, SPPB <10) and sedentary older adults (>65 years) with low-grade systemic inflammation (c-reactive protein >1mg/dL) were randomized to receive Curcumin C3 Complex® (n=9) (1000mg/day) or placebo (n=8) groups for 12 weeks. All participants (age range: 66-94 years, 8 females and 9 males) underwent functional testing (SPPB and walking speed by the 400-meter walk test) and lower-limb strength (knee flexion and extension peak torque by the Biodex test) at baseline and 12 weeks. Venous blood was collected at baseline, 4, 8 and 12 weeks for safety blood chemistry analyses and biomarkers of inflammation.
Results: A total of 17 participants were randomized and completed the study. Adherence was high (> 90%) and there were no adverse events reported or abnormal blood chemistries reported. Based on effect sizes, participants in the Curcumin C3 Complex® group demonstrated large effect sizes in the SPPB (Cohen's effect size d=0.75) and measures of knee extension (d=0.69) and flexion peak torque (d=0.82). Effect sizes for galectin-3 (d=-0.31) (larger decrease) and interleukin-6 (d=0.38) (smaller increase) were small in the Curcumin C3 Complex® group compared to placebo.
Conclusion: This pilot trial suggests that there were no difficulties with recruitment, adherence and safety specific to the study protocol. Preliminary findings warrant a Phase IIb clinical trial to test the effect of Curcumin C3 Complex® on physical function and muscle strength in older adults at risk for mobility disability.
期刊介绍:
The Journal of Frailty & Aging is a peer-reviewed international journal aimed at presenting articles that are related to research in the area of aging and age-related (sub)clinical conditions. In particular, the journal publishes high-quality papers describing and discussing social, biological, and clinical features underlying the onset and development of frailty in older persons. The Journal of Frailty & Aging is composed by five different sections: - Biology of frailty and aging In this section, the journal presents reports from preclinical studies and experiences focused at identifying, describing, and understanding the subclinical pathophysiological mechanisms at the basis of frailty and aging. - Physical frailty and age-related body composition modifications Studies exploring the physical and functional components of frailty are contained in this section. Moreover, since body composition plays a major role in determining physical frailty and, at the same time, represents the most evident feature of the aging process, special attention is given to studies focused on sarcopenia and obesity at older age. - Neurosciences of frailty and aging The section presents results from studies exploring the cognitive and neurological aspects of frailty and age-related conditions. In particular, papers on neurodegenerative conditions of advanced age are welcomed. - Frailty and aging in clinical practice and public health This journal’s section is devoted at presenting studies on clinical issues of frailty and age-related conditions. This multidisciplinary section particularly welcomes reports from clinicians coming from different backgrounds and specialties dealing with the heterogeneous clinical manifestations of advanced age. Moreover, this part of the journal also contains reports on frailty- and age-related social and public health issues. - Clinical trials and therapeutics This final section contains all the manuscripts presenting data on (pharmacological and non-pharmacological) interventions aimed at preventing, delaying, or treating frailty and age-related conditions.The Journal of Frailty & Aging is a quarterly publication of original papers, review articles, case reports, controversies, letters to the Editor, and book reviews. Manuscripts will be evaluated by the editorial staff and, if suitable, by expert reviewers assigned by the editors. The journal particularly welcomes papers by researchers from different backgrounds and specialities who may want to share their views and experiences on the common themes of frailty and aging.The abstracting and indexing of the Journal of Frailty & Aging is covered by MEDLINE (approval by the National Library of Medicine in February 2016).