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Search / Trial NCT06054607

Effect of Short-chain Fatty Acids on Aerobic Endurance

Launched by UNITED STATES ARMY RESEARCH INSTITUTE OF ENVIRONMENTAL MEDICINE · Sep 19, 2023

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Short Chain Fatty Acid Microbiome Endurance Fiber Resistant Starch Gastrointestinal

ClinConnect Summary

This clinical trial is studying how short-chain fatty acids (SCFAs), which are special substances produced in the gut, might improve aerobic endurance in healthy adults who exercise regularly. Participants will follow two different diets for one week each, one that includes a specific type of resistant starch designed to boost SCFA levels and another with a faster-digesting starch. After each diet period, they'll complete an endurance exercise session, and researchers will collect various biological samples to understand how these diets affect metabolism and overall bodily functions.

To participate, you should be between 18 and 39 years old, in good health, and regularly engage in moderate to intense exercise at least four days a week. You also need to be willing to avoid caffeine, alcohol, and certain foods and supplements during the study. If you qualify and decide to join, you'll be part of a study that aims to learn more about the connection between diet and physical performance, and you'll receive guidance throughout the process.

Gender

ALL

Eligibility 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.

About United States Army Research Institute Of Environmental Medicine

The United States Army Research Institute of Environmental Medicine (USARIEM) is a premier military research organization dedicated to enhancing the health and performance of soldiers through innovative scientific investigation. With a focus on environmental physiology, nutrition, and injury prevention, USARIEM conducts rigorous clinical trials and studies aimed at optimizing soldier readiness and resilience in diverse operational conditions. By integrating advanced research methodologies and interdisciplinary collaboration, USARIEM plays a crucial role in informing military policies and practices, ultimately contributing to the well-being and effectiveness of military personnel.

Locations

Natick, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

J. Philip Karl, PhD

Principal Investigator

United States Army Research Institute of Environmental Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported