What is the mechanism of action of this treatment?

SCFA-enriched high amylose maize starch increases colonic SCFA content through the fermentation of resistant starch by gut microbiota. SCFAs, such as acetate, propionate, and butyrate, regulate energy homeostasis, improve gut health, and modulate inflammation. They enhance insulin sensitivity, reduce fat accumulation, and provide energy for colonocytes. This is crucial for metabolism patients as it helps manage metabolic disorders like obesity, type 2 diabetes, and metabolic syndrome by improving metabolic health and reducing associated risks.

What side effects are associated with this type of intervention?

Treatments that increase colonic short-chain fatty acids (SCFAs) through the fermentation of resistant starch, such as SCFA-enriched high amylose maize starch, commonly cause gastrointestinal side effects. These include bloating, gas, and abdominal discomfort due to increased fermentation in the colon. Changes in bowel habits, such as diarrhea or constipation, may also occur. These side effects are typically mild and often decrease as the body adapts to the higher fiber intake.

What prior FDA approvals exist?

The FDA has approved several treatments for metabolic conditions, including medications like metformin for diabetes and various statins for dyslipidemia. While specific FDA approvals for treatments that increase colonic SCFA content through fermentation of resistant starch are not detailed, dietary interventions and probiotics that modulate gut microbiota are commonly recommended for metabolic health. These approaches aim to improve metabolic outcomes by enhancing gut health and influencing metabolic pathways.

What other types of research exist?

Promising alternatives to SCFA-enriched high amylose maize starch for metabolism patients include other resistant starches (e.g., potato starch, green banana flour), fermentable fibers such as inulin, and prebiotic supplements like fructooligosaccharides (FOS) and galactooligosaccharides (GOS). These alternatives can also enhance colonic SCFA production through fermentation and have shown potential benefits for metabolic health.

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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

Must not have

Swallowing disorders; severe dysphagia to food or pills

Females who are pregnant, expecting to become pregnant during the study, or breastfeeding

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.

Summary

This trial tests if special diets with different types of starch can improve exercise endurance in healthy, active adults by producing beneficial substances in the gut.

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.

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.

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 below

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My menstrual cycles are regular, between 26-32 days, or I am on a specific birth control.

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I usually have bowel movements every other day or more frequently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe difficulty swallowing food or pills.

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I am not pregnant, planning to become pregnant, or breastfeeding.

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I have a condition like kidney disease or diabetes.

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I have injuries that prevent me from exercising.

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I have a gastrointestinal condition like IBS or Crohn's disease.

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I have anemia or carry sickle cell trait.

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I have had a gastric bezoar in the past.

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I might have blockages or abnormal connections in my digestive system.

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I have a heart condition, including irregular heartbeats.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and phases 1 and 2, day 8. measured fasting (-300minutes) and before (0minutes) and at the end (80minutes) of steady state endurance exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Run time

Secondary study objectives

Fecal short-chain fatty acid concentrations

Intestinal pH

Intestinal permeability

+4 more

Other study objectives

Appetite

Breath hydrogen and methane

Circulating biomarkers of gut barrier function

+13 more

Trial 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).

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

SCFA-enriched high amylose maize starch increases colonic SCFA content through the fermentation of resistant starch by gut microbiota. SCFAs, such as acetate, propionate, and butyrate, regulate energy homeostasis, improve gut health, and modulate inflammation. They enhance insulin sensitivity, reduce fat accumulation, and provide energy for colonocytes. This is crucial for metabolism patients as it helps manage metabolic disorders like obesity, type 2 diabetes, and metabolic syndrome by improving metabolic health and reducing associated risks.