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

Completed · Not applicable

Conditions studied: Sarcopenia, Dietary Exposure, Microbial Colonization

In brief

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.

Key facts

Study ID

NCT05549622

Run by

Tufts University

People needed

31

Starts

2023-03-01

Expected to finish

2025-04-30

Last updated by the study team

2025-07-18

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Willing to consume an abundance of soluble fiber-rich foods (broccoli, brussels sprouts, flaxseeds sweetened with dates, lima beans, butternut squash, carrots, collard greens)
• Willing to tolerate mild gastrointestinal discomfort (bloating, belly grumbling, flatulence). Note that all attempts will be made to replace foods that may trigger these issues.
• Willing to not consume antibiotics during the 13-week study
• Willing to not schedule a colonoscopy during the 13-week study

You may not qualify if…

• 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
• > 5% weight loss or weight gain within the past 6-months
• A recent history of alcohol abuse (within the past 5 years)
• A history of any significant injury or surgery that currently affects physical functioning and ability to perform physical function testing
• Treatment with immunosuppressive drugs
• A prior diagnosis of organ failure (heart, liver, renal, respiratory)
• Diabetes mellitus (type 1, or type 2 with insulin therapy)
• Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
• Overt disease (cancer, dementia, cardiovascular disease)
• Chronic use of anti-inflammatory medication (corticosteroids)
• Already enrolled in another research study
• Active infection, including Tuberculosis , HIV, malaria, hepatitis, shingles, Methicillin-Resistant Staphylococcus Aureus (MRSA), SARS-CoV-2
• Any major illness or condition that may interfere with study outcomes at the discretion of the study physician
• Won't remain in Boston for the 13-week study duration
• Unwilling to complete a daily checklist aimed at quantifying the amount of food eaten on the study diet

Where it is running

• Jean Mayer Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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