Impact of Diet on the Gut-Muscle Axis in Older Adults (NCT05549622) | Clinical Trial Compass
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 range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Willing to attend three study visits (enrollment, baseline, and week-13)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of SCFAs in fecal samples
Timeframe: Change from baseline when compared with the Week-13 visit
2
Quantification of whole-body lean mass with DXA
Timeframe: Change from baseline when compared with the Week-13 visit
3
Quantification of hand grip strength
Timeframe: Change from baseline when compared with the Week-13 visit
4
Chair stand test
Timeframe: Change from baseline when compared with the Week-13 visit
. 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)
. Unwilling to complete a daily questionnaire that will assess gastrointestinal comfort
. Malnutrition (BMI \< 18.5 kg/m2)
. Use of supplemental probiotics or antibiotics, participation in an investigational drug evaluation, or a recent change in habitual medication use within the 1 month-period prior to the screening visit