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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
Be older than 18 years old
Must not have
History of chronically active inflammatory or neoplastic disease in 3 years prior to enrollment
History of chronic gastrointestinal disorder including diarrhea, inflammatory bowel disease, celiac disease; coagulation disorders, chronic immunosuppressive medication usage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14

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.
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.
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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had chronic inflammation or cancer in the last 3 years.
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I have a chronic stomach or blood clotting problem, or I take medicine that weakens my immune system.
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I have a history of liver, heart disease, diabetes, or another type of cancer.
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I take medication for high blood sugar or cholesterol.
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I have not taken antibiotics or anti-fungals in the last 3 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in fasting plasma glucose
Secondary study objectives
Change in insulin sensitivity
Change in plasma insulin
Colonic gastrointestinal permeability
+24 more
Other study objectives
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
866 Previous Clinical Trials
655,084 Total Patients Enrolled
4 Trials studying Endotoxemia
134 Patients Enrolled for Endotoxemia
USDA Beltsville Human Nutrition Research CenterFED
54 Previous Clinical Trials
5,241 Total Patients Enrolled
2 Trials studying Endotoxemia
46 Patients Enrolled for Endotoxemia
Richard Bruno, PhD, RDPrincipal InvestigatorOhio State University
5 Previous Clinical Trials
126 Total Patients Enrolled
2 Trials studying Endotoxemia
70 Patients Enrolled for Endotoxemia

Media Library

Whole Wheat Bread (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05318183 — N/A
Endotoxemia Research Study Groups: White Bread (control), Whole Wheat Bread
Endotoxemia 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
~0 spots leftby Dec 2024
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