COMPLETED

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

Conditions

Sarcopenia Dietary Exposure Microbial Colonization skeletal muscle soluble fiber gut-muscle axis microbiome SCFA Uremic metabolites

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of a High-Soluble Fiber Diet on the Gut-Muscle Axis in Older Adults

Quick Facts

Study Start:2023-03-01

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05549622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

1. Independently living older adults (\> 65y)
2. Sedentary (Godin-Shepard Leisure Time Physical Activity Questionnaire score \< 10)
3. Non-smoking
4. Not already consuming a high-fiber diet (\> 22, 28 g/day for women, men)
5. Free of gastrointestinal disease (gastrointestinal cancer, inflammatory bowel disease, bariatric surgery, irritable bowel syndrome)
6. Fluent in English
7. Willing to attend three study visits (enrollment, baseline, and week-13)
8. Willing to consume an abundance of fruits, vegetables, nuts/seeds
9. Willing to consume an abundance of soluble fiber-rich foods (broccoli, brussels sprouts, flaxseeds sweetened with dates, lima beans, butternut squash, carrots, collard greens)
10. 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.
11. Willing to not consume antibiotics during the 13-week study
12. Willing to not schedule a colonoscopy during the 13-week study

1. Unwilling to visit the Tufts Human Nutrition Research Center on Aging (HNRCA) 3x/week to pick up the pre-prepared study diet
2. Unwilling to only consume the provided food (unsweetened tea and/or black coffee are allowed)
3. Food allergies related to foods that are included in the study
4. Chewing problems
5. Unwilling to wear a daily step counter (pedometer)
6. Unwilling to complete a daily questionnaire that will assess gastrointestinal comfort
7. Malnutrition (BMI \< 18.5 kg/m2)
8. 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
9. \> 5% weight loss or weight gain within the past 6-months
10. A recent history of alcohol abuse (within the past 5 years)
11. A history of any significant injury or surgery that currently affects physical functioning and ability to perform physical function testing
12. Treatment with immunosuppressive drugs
13. A prior diagnosis of organ failure (heart, liver, renal, respiratory)
14. Diabetes mellitus (type 1, or type 2 with insulin therapy)
15. Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
16. Overt disease (cancer, dementia, cardiovascular disease)
17. Chronic use of anti-inflammatory medication (corticosteroids)
18. Already enrolled in another research study
19. Active infection, including Tuberculosis , HIV, malaria, hepatitis, shingles, Methicillin-Resistant Staphylococcus Aureus (MRSA), SARS-CoV-2
20. Any major illness or condition that may interfere with study outcomes at the discretion of the study physician
21. Won't remain in Boston for the 13-week study duration
22. Unwilling to complete a daily checklist aimed at quantifying the amount of food eaten on the study diet

Contacts and Locations

Principal Investigator

Michael S Lustgarten, PhD

STUDY_DIRECTOR

Scientist II, NEPS Laboratory

Study Locations (Sites)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111

United States

Collaborators and Investigators

Sponsor: Tufts University

Michael S Lustgarten, PhD, STUDY_DIRECTOR, Scientist II, NEPS Laboratory

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

skeletal muscle
soluble fiber
gut-muscle axis
microbiome
SCFA
Uremic metabolites

Additional Relevant MeSH Terms

Sarcopenia
Dietary Exposure
Microbial Colonization