Personalized GI Motility Responses to Diet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2025-06-02

Brief Summary

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The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.

Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses.

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Detailed Description

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Conditions

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Nutritional and Metabolic Diseases Gastrointestinal Dysfunction Cardiovascular Diseases Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, controlled, crossover

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Appearance, flavor, and texture of whole grain vs refined bread could not be masked

Study Groups

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Whole grain rye bread

4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours)

Group Type EXPERIMENTAL

Whole grain rye bread

Intervention Type OTHER

Single consumption of 4.3 oz of whole grain rye bread

Refined grain rye bread

4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours)

Group Type PLACEBO_COMPARATOR

Refined grain rye bread

Intervention Type OTHER

Single consumption of 4.3 oz of refined grain rye bread

Interventions

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Whole grain rye bread

Single consumption of 4.3 oz of whole grain rye bread

Intervention Type OTHER

Refined grain rye bread

Single consumption of 4.3 oz of refined grain rye bread

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women

Exclusion Criteria

Physician-Diagnosed:

* Diabetes Mellitus
* Nutrient-malabsorption disorders
* Intestinal Bowel Syndrome (IBS)
* Intestinal Bowel Disease (IBD)
* Bleeding-related disorders
* Grain allergy
* Psychological Disorders
* Stenosis
* Dysphasia

History of:

* Bariatric Surgery
* Gallbladder removal
* Eating disorders
* Antibiotic administration (within the past three months)
* Hormone therapy

Currently:

* Using statins
* Pregnant, lactating, or postmenopausal
* Taking oral hypoglycemic agents or insulin
* Ingesting prescription fiber
* Using cholesterol and bile acid absorption inhibitors
* Ingesting nutrition supplements, not including a daily multivitamin (i.e. herbs, tinctures, and extracts) •Using recreational drugs or alcohol (within the past week)
* Taking anti-histamines
* Taking proton pump inhibitors
* Taking antacids

Minimum Eligible Age

21 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes