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Whole grain rye bread for Nutritional and Metabolic Disorders

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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am a healthy man or woman.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Glucose
Gastrointestinal Pressure (mmHg)
Gastrointestinal Transit Time (hours:minutes)
+7 more
Secondary outcome measures
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)

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Who is running the clinical trial?

University of Illinois at Urbana-ChampaignLead Sponsor
193 Previous Clinical Trials
37,478 Total Patients Enrolled
~33 spots leftby Jun 2025
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