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Dietary Intervention

Whole Wheat Bread for Prediabetes

N/A
Waitlist Available
Led By Richard Bruno, PhD, RD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI of 30-35 kg/m2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14
Awards & highlights

Study Summary

This trial will study the effects of whole wheat consumption on gut microbiota and human health in adults with pre-diabetes.

Who is the study for?
This trial is for adults with pre-diabetes who have a BMI of 30-35 and fasting blood glucose levels between 100-125 mg/dL. It's not for those who drink more than two alcoholic drinks daily, are pregnant, have liver or heart disease, diabetes, cancer, take certain medications or supplements for blood sugar or cholesterol issues, exercise intensely over five hours weekly, smoke, recently used antibiotics or anti-fungals, or have chronic gut disorders.Check my eligibility
What is being tested?
The study tests how whole wheat bread affects the balance of gut microbes and health in people with pre-diabetes compared to white bread. Participants will eat either whole wheat (4 servings) or white bread daily for two weeks in random order before providing stool and blood samples to see if there are any changes.See study design
What are the potential side effects?
Potential side effects from changing diet to include whole wheat might be digestive discomfort such as bloating or gas. White bread is unlikely to cause new side effects unless participants have an intolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 30 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fasting plasma glucose
Secondary outcome measures
Change in insulin sensitivity
Change in plasma insulin
Colonic gastrointestinal permeability
+24 more
Other outcome measures
Gut microbiota alpha-diversity indices
Gut microbiota beta-diversity indices
Gut microbiota relative abundance
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whole Wheat BreadExperimental Treatment1 Intervention
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks
Group II: White Bread (control)Placebo Group1 Intervention
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
821 Previous Clinical Trials
501,080 Total Patients Enrolled
USDA Beltsville Human Nutrition Research CenterFED
54 Previous Clinical Trials
5,240 Total Patients Enrolled
Richard Bruno, PhD, RDPrincipal InvestigatorOhio State University
5 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Whole Wheat Bread (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05318183 — N/A
Prediabetes Research Study Groups: Whole Wheat Bread, White Bread (control)
Prediabetes Clinical Trial 2023: Whole Wheat Bread Highlights & Side Effects. Trial Name: NCT05318183 — N/A
Whole Wheat Bread (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318183 — N/A

Frequently Asked Questions

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

Are there any spots left in this research trial at the present time?

"Affirmative. Records published on clinicaltrials.gov demonstrate that this healthcare investigation, which was initially submitted to the website on April 1st 2022, is actively seeking volunteers. The research requires 40 individuals at a single medical centre."

Answered by AI

Are individuals over the age of 80 precluded from participating in this research study?

"This clinical trial's entry requirements necessitate that participants are between 18 to 65 years of age. Younger individuals can participate in 45 other trials, while those over the age of 65 have access to 462 different studies."

Answered by AI

What criteria must a participant fulfill to be included in this experiment?

"This medical trial requires 40 participants with inflammation of ages 18 and 65 to meet the following criteria: Fasting blood glucose between 100-125 mg/dL, BMI from 30-35 kg/m2."

Answered by AI

What is the enrollment capacity of this clinical trial?

"Affirmative, the information on clinicaltrials.gov attests to this medical trial's current recruitment status. The study went live on April 1st 2022 and has lately been updated in late April 2021; it is targeting 40 participants across a single site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Dec 2024