Aerobic EnduranceNCT06054607
Effect of Short-chain Fatty Acids on Aerobic Endurance
A study testing High-amylose maize starch+acetate/butyrate and Low-amylose maize starch in people with Aerobic Endurance and Metabolism, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Endurance, Metabolism
- What is being tested?
- High-amylose maize starch+acetate/butyrate and Low-amylose maize starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
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.
- Conditions
- Aerobic Endurance, Metabolism
- Being tested
- High-amylose maize starch+acetate/butyrate, Low-amylose maize starch
- Keywords
- short-chain fatty acid, microbiome, endurance, fiber, resistant starch, gastrointestinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-amylose maize starch+acetate/butyrateDietary supplement
High-amylose maize starch (HAMS), commercially available as Hylon VII (Ingredion, Inc.), to which the SCFA acetate or butyrate has been chemically added. Hylon VII is a HAMS containing ~70% amylose and used in a variety of food products. To produce SCFA-enriched HAMS, Hylon VII is chemically modified through esterification with the SCFA acetate or butyrate.
Low-amylose maize starchOther
Rapidly digestible low-amylose maize starch (0% amylose, 100% amylopectin) sold commercially as AMIOCA (Ingredion, Inc).
| Study group | Role | What they receive |
|---|---|---|
| Low-amylose maize starch | Placebo comparator | Low-amylose maize starch (AMIOCA; Ingredion, Inc). Receives: Other: Low-amylose maize starch |
| High-amylose maize starch+acetate/butyrate | Active comparator | High-amylose maize starch, (Hylon VII; Ingredion, Inc.) to which the SCFA acetate or butyrate has been chemically added. Receives: Dietary Supplement: High-amylose maize starch+acetate/butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Run time
Time to complete a 5km treadmill run
Measured: Phases 1 and 2, day 8
Secondary outcomes (6)
Muscle glycogen content
Muscle glycogen content
Measured: Phases 1 and 2, day 8
Plasma glucose turnover
Glucose production, utilization and metabolic clearance rate measured during endurance steady state exercise using 6,6-[2H2] glucose tracer
Measured: Phases 1 and 2, day 8
Whole body substrate oxidation
Carbohydrate and fat oxidation rates measured during endurance steady state exercise using indirect calorimetry
Measured: Phase 1 and 2, day 8
Serum short-chain fatty acid concentrations
Serum acetate, butyrate and propionate concentrations
Measured: Phases 1 and 2, day 8. Measured fasted (-300 minutes) and before (0 minutes) and at the end (80 minutes) of steady state endurance exercise
Fecal short-chain fatty acid concentrations
Fecal acetate, butyrate and propionate concentrations
Measured: Phases 1 and 2, days 1 and 7
Intestinal permeability
Small and large intestine permeability measured by saccharide excretion in urine
Measured: Phases 1 and 2, day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start21 Jul 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic EnduranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- J. Philip Karl, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054607
- Sponsor's protocol ID
- 23-13H
- Other IDs
- M-11031
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data and samples will remain under the control of the Principal Investigator and may be shared with outside collaborators for future research with appropriate data sharing agreements and legal/ethical approvals. De-identified microbiome sequencing data may be posted in a publicly available data repository.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-chain Fatty Acids on Aerobic Endurance
- ClinicalTrials.gov ID
- NCT06054607
- Acronym / sponsor ID
- 23-13H
- Conditions
- Aerobic Endurance, Metabolism
- Keywords
- short-chain fatty acid, microbiome, endurance, fiber, resistant starch, gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-amylose maize starch | Placebo comparator | Other: Low-amylose maize starchLow-amylose maize starch (AMIOCA; Ingredion, Inc). |
| High-amylose maize starch+acetate/butyrate | Active comparator | Dietary Supplement: High-amylose maize starch+acetate/butyrateHigh-amylose maize starch, (Hylon VII; Ingredion, Inc.) to which the SCFA acetate or butyrate has been chemically added. |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-amylose maize starch+acetate/butyrateHigh-amylose maize starch (HAMS), commercially available as Hylon VII (Ingredion, Inc.), to which the SCFA acetate or butyrate has been chemically added. Hylon VII is a HAMS containing ~70% amylose and used in a variety of food products. To produce SCFA-enriched HAMS, Hylon VII is chemically modified through esterification with the SCFA acetate or butyrate. | Dietary supplement | High-amylose maize starch+acetate/butyrate |
| Low-amylose maize starchRapidly digestible low-amylose maize starch (0% amylose, 100% amylopectin) sold commercially as AMIOCA (Ingredion, Inc). | Other | Low-amylose maize starch |
Primary outcome
Run time
Time frame: Phases 1 and 2, day 8
Time to complete a 5km treadmill run
6 secondary outcomes
Muscle glycogen content
Time frame: Phases 1 and 2, day 8
Plasma glucose turnover
Time frame: Phases 1 and 2, day 8
Whole body substrate oxidation
Time frame: Phase 1 and 2, day 8
Serum short-chain fatty acid concentrations
Time frame: Phases 1 and 2, day 8. Measured fasted (-300 minutes) and before (0 minutes) and at the end (80 minutes) of steady state endurance exercise
Fecal short-chain fatty acid concentrations
Time frame: Phases 1 and 2, days 1 and 7
Intestinal permeability
Time frame: Phases 1 and 2, day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Undecided. De-identified data and samples will remain under the control of the Principal Investigator and may be shared with outside collaborators for future research with appropriate data sharing agreements and legal/ethical approvals. De-identified microbiome sequencing data may be posted in a publicly available data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Philip Karl, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-amylose maize starch+acetate/butyrate and Low-amylose maize starch in people with Aerobic Endurance and Metabolism, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Run time (time frame: Phases 1 and 2, day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.