Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline when compared with the week-13 visit
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I do not have any gastrointestinal diseases.
Select...
I agree not to have a colonoscopy during the 13-week study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline when compared with the week-13 visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline when compared with the week-13 visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chair stand test
Fatty Acids, Volatile
Quantification of hand grip strength
+1 moreSecondary outcome measures
Walk Test
Quantification of gut bacterial composition in fecal samples
Bacteria
+2 moreTrial 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
265 Previous Clinical Trials
661,850 Total Patients Enrolled
9 Trials studying Sarcopenia
700 Patients Enrolled for Sarcopenia
Michael S Lustgarten, PhDStudy DirectorScientist II, NEPS Laboratory
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes and use insulin.I am currently taking drugs that suppress my immune system.My BMI is under 18.5, indicating malnutrition.I have lost or gained more than 5% of my weight in the last 6 months.I am over 65 years old and live independently.My kidney function is severely reduced.You don't do much physical activity in your free time.You have allergies to any of the foods used in the study.I am unable to visit the Tufts HNRCA 3 times a week for my diet.I haven't taken probiotics, antibiotics, new drugs, or changed my medication in the last month.You are not currently eating a lot of high-fiber foods.I do not have any active infections like TB, HIV, malaria, hepatitis, shingles, MRSA, or COVID-19.I have a diagnosed condition like cancer, dementia, or heart disease.I have had organ failure in the past (heart, liver, kidney, or lungs).I do not have any gastrointestinal diseases.I agree not to have a colonoscopy during the 13-week study.I have had an injury or surgery that affects my physical abilities.Difficulty chewingYou have had a problem with drinking too much alcohol in the past 5 years.I regularly take anti-inflammatory medication.You are okay with feeling a little discomfort in your stomach, like bloating or gas, and we will try to give you different foods if needed.Willing to eat a lot of foods that are high in soluble fiber, like broccoli, brussels sprouts, flaxseeds sweetened with dates, lima beans, butternut squash, carrots, and collard greens.I am unwilling to wear a step counter daily.You do not smoke cigarettes.
Research Study Groups:
This trial has the following groups:- Group 1: Low-soluble fiber diet
- Group 2: High-soluble fiber diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities presently available for participants in this trial?
"With confirmation from clinicaltrials.gov, this trial is actively seeking qualified individuals to participate in the study. The research was initially posted on March 1st 2023 and has been revised once since then - on April 10th of the same year."
Answered by AI
What is the highest capacity for participants involved in this medical research?
"Yes, the records posted on clinicaltrials.gov suggests that this medical study is actively enrolling patients. It was first shared on March 1st 2023 and was recently updated April 10th 2023. The researchers are currently looking for 24 trial participants at one location."
Answered by AI
What outcome is this experimentation seeking to accomplish?
"This research project aims to evaluate the change in Fecal SCFAs from baseline when compared with Week-13. Secondary outcomes include Quantification of gut bacterial metabolites in plasma, Gut bacterial composition and Thigh muscle composition which will all be determined at both the beginning and end of the study."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger