Effects of short-chain fatty acids on aerobic endurance
Effect of Short-chain Fatty Acids on Aerobic Endurance
This study is testing whether adding short-chain fatty acids to the diet can help healthy adults improve their aerobic endurance during exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 17 Years to 39 Years |
| Sex | All |
| Sponsor | United States Army Research Institute of Environmental Medicine Federal |
| Locations | 1 site (Natick, Massachusetts) |
| Trial ID | NCT06054607 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled crossover study aims to evaluate how increasing colonic short-chain fatty acid (SCFA) content affects aerobic endurance in healthy adults. Participants will consume diets supplemented with SCFA-enriched high amylose maize starch or low amylose maize starch over two separate one-week periods, with a washout phase in between. After each dietary intervention, participants will undergo an endurance exercise bout and a time trial, while biological samples will be collected to analyze metabolism, gut microbiota, inflammation, and gastrointestinal function.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18-39 who regularly engage in moderate to high-intensity aerobic exercise.
Not a fit: Patients who do not meet the exercise frequency criteria or have underlying health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance aerobic endurance in physically active individuals through dietary modifications.
How similar studies have performed: While the specific approach of using SCFAs for enhancing endurance is novel, related studies on dietary fibers and gut health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 18 - 39 years (active-duty personnel who are 17 yr of age will also be allowed to participate). * In good health. * Routinely participate in moderate or higher intensity aerobic and/or resistance exercise at least 4 days per week for ≥20 min/d. * Meet Army weight for height and body composition standards as defined in Army Regulation 600-9. * Self-reports a usual bowel movement frequency of every other day or more often. * Willing to refrain from the use of caffeine, alcohol, and nicotine while consuming study diets. * Willing to refrain from all dietary supplements beginning 2 weeks prior to study start and throughout study participation. * 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. * Willing to participate in all study procedures. * 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). Exclusion Criteria: * Females who are pregnant, expecting to become pregnant during the study, or breastfeeding. * Any of the following medical conditions: Cardiac disease (including arrhythmia or fast or skipped heart beats) Hypertension Musculoskeletal injuries that compromise exercise capability Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, etc.) Disease of the GI tract including, but not limited to diverticulitis, inflammatory bowel disease, irritable bowel syndrome, peptic ulcer disease, Crohn's disease, and ulcerative colitis Allergy to skin adhesive or Lidocaine (or other local anesthetic being used in place of Lidocaine) Suspected or known strictures, fistulas, or physiological/mechanical GI obstruction History of gastric bezoar Swallowing disorders; severe dysphagia to food or pills Implanted or portable electro-mechanical medical devices (e.g., pacemaker) * Colonoscopy within 3 months of study participation. * Any use of antibiotics or antimycotics, except topical antibiotics/antimycotics, within 3 months of study participation. * 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. * Use of medication (i.e., diabetes medications, statins, corticosteroids, etc.) that affects macronutrient utilization and/or the ability to participate in strenuous exercise. * Anemia (HCT \<38 for men and \<34 for women) or Sickle Cell Anemia/Trait. * Not willing or able to follow all study procedures and diet/exercise restrictions. * Allergies, intolerances, unwillingness or inability to eat provided foods and beverages. * Following vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet, etc.). * 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.
Where this trial is running
Natick, Massachusetts
- United States Army Research Institute of Environmental Medicine — Natick, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: J. Philip Karl, PhD — United States Army Research Institute of Environmental Medicine
- Study coordinator: J. Philip Karl, PhD
- Email: james.p.karl.civ@health.mil
- Phone: 508-206-2318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.