Whole Wheat Bread for Prediabetes

Overseen By Richard Bruno, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Hyperglycemia, Dyslipidemia, Antibiotics, Antifungals

Disqualifiers: Liver disease, Cardiovascular disease, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how whole wheat bread affects the gut health of people with prediabetes. Participants will consume both whole wheat and white bread to determine any health differences. The researchers aim to discover if whole wheat bread offers a healthier option for those with prediabetes. Ideal candidates for this trial have a fasting blood sugar level between 100-125 mg/dL and a BMI (a measure of body fat) of 30-35. As an unphased trial, participants contribute to valuable research that may enhance dietary recommendations for prediabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications for high blood sugar or cholesterol.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that whole wheat bread helped lower blood sugar and cholesterol levels in people with type 2 diabetes. This finding suggests it might also be safe and beneficial for those with prediabetes. Research has shown that whole wheat bread generally has positive health effects and is safe for most people. No major reports of serious side effects from consuming it have emerged. This makes it a well-tolerated choice for many, especially compared to refined grains, which can increase the risk of type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whole wheat bread as a treatment for prediabetes because it offers a natural, dietary approach that may improve blood sugar control. Unlike standard medications for prediabetes, which often include drugs like metformin, whole wheat bread could provide an easier, more accessible option for individuals looking to manage their condition through diet. Whole wheat bread is rich in fiber, which helps slow down the digestion and absorption of carbohydrates, leading to more stable blood sugar levels. This simple dietary change might offer benefits with fewer side effects and a more straightforward integration into daily life.

What evidence suggests that whole wheat bread might be an effective treatment for prediabetes?

Research has shown that eating whole wheat bread might help manage blood sugar levels. One study found that consuming whole grain wheat bread for three months lowered blood sugar and a marker of long-term blood sugar control. Another study demonstrated that whole wheat can improve blood sugar levels in various individuals. Additionally, consuming 50 grams of whole grains daily has been linked to a lower risk of developing type 2 diabetes. In this trial, participants will consume either whole wheat bread or white bread as a control to evaluate the effects on prediabetes. These findings suggest that whole wheat bread could be helpful for managing prediabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

Richard Bruno, PhD, RD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your blood sugar level when you haven't eaten is between 100-125 mg/dL.

Your body mass index (BMI) is between 30 and 35.

Exclusion Criteria

You smoke cigarettes.

I haven't had chronic inflammation or cancer in the last 3 years.

I have a chronic stomach or blood clotting problem, or I take medicine that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants consume either whole wheat bread or white bread daily for two weeks in a randomized, controlled crossover trial

2 weeks per intervention arm

2 visits (in-person) per arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• White Bread (control)
• Whole Wheat Bread

Trial Overview 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.

How Is the Trial Designed?

Group I: Whole Wheat Bread Experimental Treatment 1 Intervention

Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks

Group II: White Bread (control) Placebo Group 1 Intervention

Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

USDA Beltsville Human Nutrition Research Center

Collaborator

Trials

56

Recruited

5,300+

Published Research Related to This Trial

In a study involving 121 type 2 diabetic patients, whole wheat, wheat bran, and rye breads did not significantly differ in their effects on blood glucose and insulin levels compared to white wheat bread.

All four types of bread led to similar increases in blood glucose levels, indicating that these alternative breads may not be effective substitutes for white bread in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary breads: myth or reality? Mesci, B., Oguz, A., Sagun, HG., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8531422/

Effect of Consumption of Whole-Wheat Breads on FBS, HbA1c ... In general, this study showed that consuming 180 g/d wholegrain wheat bread for 3 months can control blood sugar levels, and reduce glycosylated hemoglobin, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531724001246

Intestinal-level anti-inflammatory bioactivities of whole ... Randomized controlled trials (RCT) demonstrate that whole wheat consumption improves glycemia. However, substantial inter-individual variation is often ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11044462/

Effects of whole grains on glycemic control: a systematic ... Cohort studies suggested a 50 g/day whole grain intake reduced the risk of type 2 diabetes (RR = 0.761, 95% CI: 0.700 to 0.828, I2 = 72.39%, P < ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(25)00370-3/fulltext

Effectiveness of regular oat β-glucan–enriched bread ... This study aims to assess the long-term effectiveness of daily consumption of β-glucan–enriched bread, compared with whole-grain wheat bread, on glycated ...

5. withpower.com withpower.com/trial/phase-glucose-intolerance-3-2022-344b7

Whole Wheat Bread for Prediabetes · Info for Participants Research shows that whole wheat bread can help lower blood sugar levels and improve cholesterol in people with type 2 diabetes, which suggests it might also be ...

6. bmj.com bmj.com/content/370/bmj.m2206

Intake of whole grain foods and risk of type 2 diabetes A meta-analysis of prospective cohort studies showed that total whole grain consumption was associated with a lower risk of type 2 diabetes.43 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10102991/

The Effect of Regular Consumption of Reformulated Breads ... High intakes of refined grains, low in dietary fiber and high in glycemic index, are linked with increased risk for type 2 diabetes mellitus (T2DM) and other ...