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Whole grain rye bread for Imbalance of Microbes

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 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

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)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at Urbana-ChampaignLead Sponsor

191 Previous Clinical Trials

37,393 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this clinical trial?

"Individuals aged between 21 and 63 with a history of cardiovascular disease are eligible to enroll in this study. The trial is accepting approximately 50 participants."

Answered by AI

Are patients still being enrolled in this ongoing medical study?

"Indeed, information from clinicaltrials.gov indicates that this particular research study is actively seeking eligible participants. Originally shared on March 7th, 2024, the trial's most recent update was made on April 23rd of the same year. The investigation aims to enroll a total of 50 subjects at one designated site."

Answered by AI

Are participants aged 80 and above eligible for enrollment in this research study?

"Patients eligible for this research study must fall within the age range of 21 to 63 years. It is noteworthy that there are a total of 65 clinical trials tailored for individuals below 18 years old and an additional 525 studies designed for those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized GI Motility Responses to Diet

2024. "Personalized GI Motility Responses to Diet". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06386471.

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