MedPath

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

Not Applicable
Recruiting
Conditions
Sarcopenia
Dietary Exposure
Microbial Colonization
Registration Number
NCT05549622
Lead Sponsor
Tufts University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
24
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Independently living older adults (> 65y)<br><br> 2. Sedentary (Godin-Shepard Leisure Time Physical Activity Questionnaire score < 10)<br><br> 3. Non-smoking<br><br> 4. Not already consuming a high-fiber diet (> 22, 28 g/day for women, men)<br><br> 5. Free of gastrointestinal disease (gastrointestinal cancer, inflammatory bowel<br> disease, bariatric surgery, irritable bowel syndrome)<br><br> 6. Fluent in English<br><br> 7. Willing to attend three study visits (enrollment, baseline, and week-13)<br><br> 8. Willing to consume an abundance of fruits, vegetables, nuts/seeds<br><br> 9. Willing to consume an abundance of soluble fiber-rich foods (broccoli, brussels<br> sprouts, flaxseeds sweetened with dates, lima beans, butternut squash, carrots,<br> collard greens)<br><br> 10. Willing to tolerate mild gastrointestinal discomfort (bloating, belly grumbling,<br> flatulence). Note that all attempts will be made to replace foods that may trigger<br> these issues.<br><br> 11. Willing to not consume antibiotics during the 13-week study<br><br> 12. Willing to not schedule a colonoscopy during the 13-week study<br><br>Exclusion Criteria:<br><br> 1. Unwilling to visit the Tufts Human Nutrition Research Center on Aging (HNRCA)<br> 3x/week to pick up the pre-prepared study diet<br><br> 2. Unwilling to only consume the provided food (unsweetened tea and/or black coffee are<br> allowed)<br><br> 3. Food allergies related to foods that are included in the study<br><br> 4. Chewing problems<br><br> 5. Unwilling to wear a daily step counter (pedometer)<br><br> 6. Unwilling to complete a daily questionnaire that will assess gastrointestinal<br> comfort<br><br> 7. Malnutrition (BMI < 18.5 kg/m2)<br><br> 8. Use of supplemental probiotics or antibiotics, participation in an investigational<br> drug evaluation, or a recent change in habitual medication use within the 1<br> month-period prior to the screening visit<br><br> 9. > 5% weight loss or weight gain within the past 6-months<br><br> 10. A recent history of alcohol abuse (within the past 5 years)<br><br> 11. A history of any significant injury or surgery that currently affects physical<br> functioning and ability to perform physical function testing<br><br> 12. Treatment with immunosuppressive drugs<br><br> 13. A prior diagnosis of organ failure (heart, liver, renal, respiratory)<br><br> 14. Diabetes mellitus (type 1, or type 2 with insulin therapy)<br><br> 15. Chronic kidney disease (eGFR = 30 mL/min/1.73 m2)<br><br> 16. Overt disease (cancer, dementia, cardiovascular disease)<br><br> 17. Chronic use of anti-inflammatory medication (corticosteroids)<br><br> 18. Already enrolled in another research study<br><br> 19. Active infection, including Tuberculosis , HIV, malaria, hepatitis, shingles,<br> Methicillin-Resistant Staphylococcus Aureus (MRSA), SARS-CoV-2<br><br> 20. Any major illness or condition that may interfere with study outcomes at the<br> discretion of the study physician<br><br> 21. Won't remain in Boston for the 13-week study duration<br><br> 22. Unwilling to complete a daily checklist aimed at quantifying the amount of food<br> eaten on the study diet

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quantification of SCFAs in fecal samples;Quantification of whole-body lean mass with DXA;Quantification of hand grip strength;Chair stand test
Secondary Outcome Measures
NameTimeMethod
Quantification of thigh muscle composition with computed tomography;6-minute walk test;Quantification of gut bacterial metabolites in plasma;Quantification of gut bacterial composition in fecal samples;Quantification of pH in fecal samples
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