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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).

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.

What data supports the effectiveness of whole wheat bread as a treatment for prediabetes?

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 beneficial for those with prediabetes. ^{1 2 3 4 5}

Is whole wheat bread safe for human consumption?

Whole wheat bread is generally safe for human consumption and has been shown to have positive effects on blood sugar and cholesterol levels in people with type 2 diabetes, without causing physical discomfort. ^{1 2 4 6 7}

How does whole wheat bread differ from other treatments for prediabetes?

Whole wheat bread is unique because it is a natural food product that can help manage blood sugar levels due to its low glycemic index (a measure of how quickly foods raise blood sugar). Unlike medications, it is consumed as part of a regular diet and can improve blood sugar control and lipid profiles without the need for pharmaceutical intervention. ^{1 2 4 7 8}

Research Team

Richard Bruno, PhD, RD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

USDA Beltsville Human Nutrition Research Center

Collaborator

Trials

56

Recruited

5,300+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of Regular Consumption of Reformulated Breads on Glycemic Control: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Consumption of Whole-Wheat Breads on FBS, HbA1c, and Blood Lipids in Patients with Type 2 Diabetes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Sixteen-week multicentre randomised controlled trial to study the effect of the consumption of an oat beta-glucan-enriched bread versus a whole-grain wheat bread on glycaemic control among persons with pre-diabetes: a study protocol of the CarbHealth study. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Dietary breads: myth or reality? [2017]

5. England pubmed.ncbi.nlm.nih.gov

Epidemiological support for the protection of whole grains against diabetes. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Organoleptic and glycemic properties of chickpea-wheat composite breads. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Glycaemic responses to different types of bread in insulin-dependent diabetic subjects (IDDM): studies at constant insulinaemia. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Low glycemic response to traditionally processed wheat and rye products: bulgur and pumpernickel bread. [2018]