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Fiber Supplement
Dietary Fibers for Aerobic Endurance
N/A
Recruiting
Led By J. Philip Karl, PhD
Research Sponsored by United States Army Research Institute of Environmental Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Self-reports a usual bowel movement frequency of every other day or more often
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phases 1 and 2, day 8. measured fasted (-300minutes) and before (0minutes), during (40minutes) and at the end (80minutes) of steady state endurance exercise.
Awards & highlights
Study Summary
This trial will study how adding certain fibers to diets affects exercise performance & how biological changes may explain results.
Who is the study for?
This trial is for healthy, active-duty adults aged 18-39 who exercise regularly and meet Army body composition standards. Women must have normal menstrual cycles or be on low-dose hormonal contraceptives. Participants must avoid caffeine, alcohol, nicotine, dietary supplements, and certain foods before and during the study. Exclusions include GI issues, recent colonoscopy, pregnancy/breastfeeding, metabolic/cardiovascular abnormalities, anemia/sickle cell trait/disease.Check my eligibility
What is being tested?
The study tests how short-chain fatty acids (SCFAs) from high amylose maize starch affect aerobic endurance compared to a placebo of low amylose maize starch in physically active adults. It's a randomized double-blind crossover trial with two one-week diet periods separated by at least two weeks. Endurance exercises are performed post-diet; biological samples are collected to analyze metabolism and gut health.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort due to changes in fiber intake from the SCFA-enriched diets or allergic reactions to ingredients in the provided foods. However, as this is a nutrition-based intervention involving commonly consumed substances rather than novel drugs or treatments, significant side effects are not typically expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My menstrual cycles are regular, between 26-32 days, or I am on a specific birth control.
Select...
I usually have bowel movements every other day or more frequently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phases 1 and 2, day 8. measured fasting (-300minutes) and before (0minutes) and at the end (80minutes) of steady state endurance exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phases 1 and 2, day 8. measured fasting (-300minutes) and before (0minutes) and at the end (80minutes) of steady state endurance exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Run time
Secondary outcome measures
Fecal short-chain fatty acid concentrations
Intestinal pH
Intestinal permeability
+4 moreOther outcome measures
Appetite
Breath hydrogen and methane
Circulating biomarkers of gut barrier function
+13 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: High-amylose maize starch+acetate/butyrateActive Control1 Intervention
High-amylose maize starch, (Hylon VII; Ingredion, Inc.) to which the SCFA acetate or butyrate has been chemically added.
Group II: Low-amylose maize starchPlacebo Group1 Intervention
Low-amylose maize starch (AMIOCA; Ingredion, Inc).
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Who is running the clinical trial?
United States Army Research Institute of Environmental MedicineLead Sponsor
59 Previous Clinical Trials
3,418 Total Patients Enrolled
J. Philip Karl, PhDPrincipal InvestigatorUnited States Army Research Institute of Environmental Medicine
1 Previous Clinical Trials
33 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to participate in this scientific experiment?
"To be eligible to partake in this research, individuals must have a healthy metabolism and fit the age criteria of between 17 to 39 years old. Ultimately, 12 participants are needed for the trial."
Answered by AI
Does this research study still have open enrollment?
"As per the clinicaltrials.gov listing, this research is currently recruiting participants. First posted on July 21st 2023 and last updated September 19th of the same year."
Answered by AI
How many participants are being assessed for this research project?
"Affirmative, according to clinicaltrials.gov this investigation is still in the process of searching for suitable candidates. The trial was first distributed on July 21st 2023 and has since been amended as recently as September 19th 2023. 12 people are required from one centre for participation."
Answered by AI
Does this research study accommodate participants over the age of forty?
"This clinical trial is accepting patients aged 17 to 39 as participants. For those that are under the legal age of consent, there are 3 trials they may be eligible for while individuals over 65 have access to 9 applicable studies."
Answered by AI
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