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High-Soluble Fiber Diet for Sarcopenia

N/A
Recruiting
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Free of gastrointestinal disease (gastrointestinal cancer, inflammatory bowel disease, bariatric surgery, irritable bowel syndrome)
Willing to not schedule a colonoscopy during the 13-week study
Must not have
Diabetes mellitus (type 1, or type 2 with insulin therapy)
Treatment with immunosuppressive drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline when compared with the week-13 visit
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve muscle health in older adults by targeting the gut with a diet enriched in fiber to feed beneficial bacteria.

Who is the study for?
This trial is for non-smoking, English-speaking older adults over 65 who live independently and lead a sedentary lifestyle. They should be free of gastrointestinal diseases, willing to eat high-soluble fiber foods without major dietary restrictions or allergies, and not planning significant weight changes or medical procedures that could affect the study.
What is being tested?
The study tests how diets with different levels of soluble fiber affect gut bacteria and muscle health in older adults. Participants will follow either a low-soluble fiber diet or a high-soluble fiber diet for 13 weeks to see if there's an impact on their muscle-related measures.
What are the potential side effects?
Participants may experience mild gastrointestinal discomfort such as bloating, belly grumbling, and flatulence due to the high intake of soluble-fiber-rich foods. The study aims to minimize these side effects by adjusting food choices when possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any gastrointestinal diseases.
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I agree not to have a colonoscopy during the 13-week study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes and use insulin.
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I am currently taking drugs that suppress my immune system.
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My BMI is under 18.5, indicating malnutrition.
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I have lost or gained more than 5% of my weight in the last 6 months.
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I have a diagnosed condition like cancer, dementia, or heart disease.
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My kidney function is severely reduced.
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I am unable to visit the Tufts HNRCA 3 times a week for my diet.
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I do not have any active infections like TB, HIV, malaria, hepatitis, shingles, MRSA, or COVID-19.
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I have had organ failure in the past (heart, liver, kidney, or lungs).
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I have had an injury or surgery that affects my physical abilities.
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I regularly take anti-inflammatory medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline when compared with the week-13 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline when compared with the week-13 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chair stand test
Fatty Acids, Volatile
Quantification of hand grip strength
+1 more
Secondary study objectives
Walk Test
Quantification of gut bacterial composition in fecal samples
Bacteria
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low-soluble fiber dietExperimental Treatment1 Intervention
Group II: High-soluble fiber dietActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Tufts UniversityLead Sponsor
270 Previous Clinical Trials
594,867 Total Patients Enrolled
9 Trials studying Sarcopenia
700 Patients Enrolled for Sarcopenia
Michael S Lustgarten, PhDStudy DirectorScientist II, NEPS Laboratory

Media Library

High-soluble fiber diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05549622 — N/A
Sarcopenia Research Study Groups: Low-soluble fiber diet, High-soluble fiber diet
Sarcopenia Clinical Trial 2023: High-soluble fiber diet Highlights & Side Effects. Trial Name: NCT05549622 — N/A
High-soluble fiber diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05549622 — N/A
~4 spots leftby Apr 2025
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