Personalized GI Motility Responses to Diet

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: Dysbiosis; Gastrointestinal Dysfunction; Cardiovascular Diseases; Nutritional and Metabolic Diseases

Treatments: Other: Refined grain rye bread; Other: Whole grain rye bread

Study type: Interventional

Funder types: Other

Identifiers

NCT06386471

24093

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 63 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Whole grain rye bread

Experimental group

Description:

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

Treatment:

Other: Whole grain rye bread

Refined grain rye bread

Placebo Comparator group

Description:

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

Treatment:

Other: Refined grain rye bread