COMPLETED

Effect of Short-chain Fatty Acids on Aerobic Endurance

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

Randomized, double-blind, placebo-controlled crossover study designed to determine the effects of increasing colonic short-chain fatty acid (SCFA) content on aerobic endurance in healthy adults, and to identify underpinning mechanisms. In random order, healthy physically active adults will consume provided diets low in fiber and supplemented with SCFA-enriched high amylose maize starch (a poorly digested resistant starch considered a fermentable fiber) or low amylose maize starch (a rapidly digestible starch) for 1-week separated by a ≥2-week washout. At the end of each intervention period, participants will complete an endurance exercise bout followed by a time trial. Biological samples will be collected to assess muscle and whole body metabolism, gut microbiota, inflammation, and gastrointestinal function.

Official Title

Effect of Short-chain Fatty Acids on Aerobic Endurance

Quick Facts

Study Start:2023-07-21
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06054607

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:17 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women aged 18 - 39 years (active-duty personnel who are 17 yr of age will also be allowed to participate).
  2. * In good health.
  3. * Routinely participate in moderate or higher intensity aerobic and/or resistance exercise at least 4 days per week for ≥20 min/d.
  4. * Meet Army weight for height and body composition standards as defined in Army Regulation 600-9.
  5. * Self-reports a usual bowel movement frequency of every other day or more often.
  6. * Willing to refrain from the use of caffeine, alcohol, and nicotine while consuming study diets.
  7. * Willing to refrain from all dietary supplements beginning 2 weeks prior to study start and throughout study participation.
  8. * Willing to refrain from consumption of any foods containing live microorganisms (e.g., yogurt, kefir, kombucha) or added prebiotics (e.g. Fiber One products) beginning 2 weeks prior to study start and throughout study participation.
  9. * Willing to participate in all study procedures.
  10. * Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or be using an oral/hormonal contraceptive which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos).
  1. * Females who are pregnant, expecting to become pregnant during the study, or breastfeeding.
  2. * Any of the following medical conditions:
  3. * Colonoscopy within 3 months of study participation.
  4. * Any use of antibiotics or antimycotics, except topical antibiotics/antimycotics, within 3 months of study participation.
  5. * Regular (i.e., weekly or more frequent) use of over-the-counter medications (including antacids, laxatives, stool softeners, and anti-diarrheals) unless approved by study PI.
  6. * Use of medication (i.e., diabetes medications, statins, corticosteroids, etc.) that affects macronutrient utilization and/or the ability to participate in strenuous exercise.
  7. * Anemia (HCT \<38 for men and \<34 for women) or Sickle Cell Anemia/Trait.
  8. * Not willing or able to follow all study procedures and diet/exercise restrictions.
  9. * Allergies, intolerances, unwillingness or inability to eat provided foods and beverages.
  10. * Following vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet, etc.).
  11. * Any previous blood donation within the previous 8 weeks that when combined with the volume of blood collected for the study within any 8-week period would exceed 550mL.

Contacts and Locations

Principal Investigator

J. Philip Karl, PhD
PRINCIPAL_INVESTIGATOR
United States Army Research Institute of Environmental Medicine

Study Locations (Sites)

United States Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
United States

Collaborators and Investigators

Sponsor: United States Army Research Institute of Environmental Medicine

  • J. Philip Karl, PhD, PRINCIPAL_INVESTIGATOR, United States Army Research Institute of Environmental Medicine

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 Date2023-07-21
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2023-07-21
Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

  • short-chain fatty acid
  • microbiome
  • endurance
  • fiber
  • resistant starch
  • gastrointestinal

Additional Relevant MeSH Terms

  • Aerobic Endurance
  • Metabolism