CompletedNot Applicable

Impact of Diet on the Gut-Muscle Axis in Older Adults

United States31 participantsStarted 2023-03-01

Plain-language summary

Muscle health declines during aging. One factor that may impact muscle health is the community of bacteria that live in our intestines, but studies aimed at improving muscle health by targeting the gut in older adults are sparse. The primary goal of this study is to use a diet that is enriched in soluble fiber, which is exclusively utilized by gut bacteria to make substances that can impact muscle health, to improve muscle-related measures in older adults.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Independently living older adults (\> 65y)
✓. Sedentary (Godin-Shepard Leisure Time Physical Activity Questionnaire score \< 10)
✓. Non-smoking
✓. Not already consuming a high-fiber diet (\> 22, 28 g/day for women, men)
✓. Free of gastrointestinal disease (gastrointestinal cancer, inflammatory bowel disease, bariatric surgery, irritable bowel syndrome)
✓. Fluent in English
✓. Willing to attend three study visits (enrollment, baseline, and week-13)
✓. Willing to consume an abundance of fruits, vegetables, nuts/seeds

Exclusion criteria

✕. Unwilling to visit the Tufts Human Nutrition Research Center on Aging (HNRCA) 3x/week to pick up the pre-prepared study diet
✕. Unwilling to only consume the provided food (unsweetened tea and/or black coffee are allowed)
✕. Food allergies related to foods that are included in the study
✕. Chewing problems
✕. Unwilling to wear a daily step counter (pedometer)
✕

What they're measuring

Quantification of SCFAs in fecal samples

Timeframe: Change from baseline when compared with the Week-13 visit

Quantification of whole-body lean mass with DXA

Timeframe: Change from baseline when compared with the Week-13 visit

Quantification of hand grip strength

Timeframe: Change from baseline when compared with the Week-13 visit

Chair stand test

Timeframe: Change from baseline when compared with the Week-13 visit

Trial details

NCT IDNCT05549622

SponsorTufts University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Sarcopenia trials

Plain-language summary

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Independently living older adults (\> 65y)
✓. Sedentary (Godin-Shepard Leisure Time Physical Activity Questionnaire score \< 10)
✓. Non-smoking
✓. Not already consuming a high-fiber diet (\> 22, 28 g/day for women, men)
✓. Free of gastrointestinal disease (gastrointestinal cancer, inflammatory bowel disease, bariatric surgery, irritable bowel syndrome)
✓. Fluent in English
✓. Willing to attend three study visits (enrollment, baseline, and week-13)
✓. Willing to consume an abundance of fruits, vegetables, nuts/seeds

Exclusion criteria

✕. Unwilling to visit the Tufts Human Nutrition Research Center on Aging (HNRCA) 3x/week to pick up the pre-prepared study diet
✕. Unwilling to only consume the provided food (unsweetened tea and/or black coffee are allowed)
✕. Food allergies related to foods that are included in the study
✕. Chewing problems
✕. Unwilling to wear a daily step counter (pedometer)
✕

What they're measuring

Quantification of SCFAs in fecal samples

Timeframe: Change from baseline when compared with the Week-13 visit

Quantification of whole-body lean mass with DXA

Timeframe: Change from baseline when compared with the Week-13 visit

Quantification of hand grip strength

Timeframe: Change from baseline when compared with the Week-13 visit

Chair stand test

Timeframe: Change from baseline when compared with the Week-13 visit