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Whole Grains vs Refined Grains for Metabolic Health

N/A

Recruiting

Research Sponsored by University of Illinois at Urbana-Champaign

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy men and women

Be between 18 and 65 years old

Must not have

Physician-Diagnosed: Stenosis

Physician-Diagnosed: Diabetes Mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8 hours post bread and smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)

Awards & highlights

Summary

This trial aims to study how eating whole grains versus refined grains affects gut movement and the production of beneficial substances by gut bacteria that are important for heart and metabolic health. Participants will be asked to eat whole

Who is the study for?

This trial is for individuals with cardiovascular or metabolic diseases, an imbalance of gut microbes, nutritional issues, or gastrointestinal dysfunction. Participants will need to be comfortable consuming different types of rye bread and using a Smartpill device to monitor their digestive system.

What is being tested?

The study tests how whole grain and refined grain rye bread affect the digestive system's movement patterns, the production of certain substances by gut microbes, and levels of blood sugar, fats like triglycerides and cholesterol after eating.

What are the potential side effects?

There may not be significant side effects from eating rye bread; however, swallowing the Smartpill monitoring device could cause discomfort or complications if one has difficulty swallowing pills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy man or woman.

Exclusion Criteria

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

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My doctor diagnosed me with stenosis.

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I have been diagnosed with diabetes by a doctor.

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I have a bleeding disorder diagnosed by a doctor.

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I am currently taking medication to lower my cholesterol.

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I have been diagnosed with a psychological disorder by a doctor.

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I have undergone hormone therapy in the past.

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I have had weight loss surgery in the past.

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I am currently taking statins.

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I have had my gallbladder removed.

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I am currently taking prescription fiber.

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I have been diagnosed with IBD by a doctor.

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I am currently taking medication for diabetes.

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I have been diagnosed with difficulty swallowing.

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I am currently pregnant, breastfeeding, or have gone through menopause.

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I am currently taking anti-histamines.

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I am currently taking medication for stomach acid.

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I am currently taking antacids.

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I am currently taking nutritional supplements beyond a daily multivitamin.

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I have a condition that prevents my body from absorbing nutrients properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8 hours post bread and smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 8 hours post bread and smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 hours post bread and smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Blood Glucose

Gastrointestinal Pressure (mmHg)

Gastrointestinal Transit Time (hours:minutes)

+7 more

Secondary study objectives

Metabolomics

Microbiome

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Whole grain rye breadExperimental Treatment1 Intervention

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

Group II: Refined grain rye breadPlacebo Group1 Intervention

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

0 / 20Eligibility criteria met

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Who is running the clinical trial?

University of Illinois at Urbana-ChampaignLead Sponsor

196 Previous Clinical Trials

38,153 Total Patients Enrolled

~33 spots leftby Sep 2025

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