Sourdough Bread for Prediabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Metformin

Disqualifiers: Carb-restricted diet, Smoker, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

15 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are using medications that affect blood glucose.

What data supports the effectiveness of the treatment Sourdough Bread for prediabetes?

Research shows that sourdough bread can help lower blood sugar and insulin levels after meals in people with impaired glucose tolerance, which is a condition similar to prediabetes. This effect is likely due to the lactic acid produced during the bread-making process and the reduced availability of simple carbohydrates. ^{1 2 3 4 5}

Is sourdough bread safe for human consumption?

Sourdough bread is generally considered safe for human consumption, and studies suggest it may have benefits like improved blood sugar and insulin responses. However, some people may have adverse reactions to certain cereal components in sourdough, depending on the specific ingredients and fermentation process used. ^{1 2 3 6 7}

How does sourdough bread differ from other treatments for prediabetes?

Sourdough bread is unique because it is leavened with lactobacilli, which produce lactic acid, leading to a lower blood sugar and insulin response compared to bread made with regular baker's yeast. This makes it potentially beneficial for people with impaired glucose metabolism, as it may help manage blood sugar levels more effectively than traditional bread. ^{1 2 3 6 8}

What is the purpose of this trial?

The primary intervention for management of prediabetes is lifestyle changes. Eating healthier and increasing physical activity was found to slow the progression of prediabetes into diabetes, reduce the risk of other diseases like cardiovascular disease and hypertension, and have a lasting impact even after the intervention is discontinued. Studies found that increasing the intake of fiber, pre- and probiotics, and fermented foods have been linked to improved glycemic biomarkers. The goal of this crossover randomized trial is to assess the relationship between lengthened fermentation time of sourdough bread, e.g., an increased amount of lactic acid and acetic acid in the bread product, and postprandial glycemic response in healthy adults with prediabetes.

Eligibility Criteria

This trial is for adults with prediabetes who aren't on metformin, have no food allergies or sensitivities, and aren't taking pre/postbiotic supplements. It's not for those on low-carb diets, using meds that affect blood sugar, currently ill, smoking, pregnant or lactating women, anyone with GI tract surgery history, or unwilling to follow the study protocol.

Inclusion Criteria

I have prediabetes and am not taking metformin.

No known food allergies or sensitivities

Not supplementing pre/post biotics

Exclusion Criteria

Lactation

Acute illness

Smoking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume sourdough bread with varying fermentation times to assess postprandial glycemic response

4 weeks

Multiple visits for each bread type

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sourdough Bread

Trial Overview The trial is testing how different durations of sourdough bread fermentation (24h, 48h & 72h) affect blood sugar levels after eating in prediabetic adults. Participants will try various types of sourdough to see if longer fermentation improves glycemic response compared to regular yeast bread.

Participant Groups

Group I: sourdough bread 72 Experimental Treatment 1 Intervention

Group II: sourdough bread 48 Experimental Treatment 1 Intervention

Group III: sourdough bread 24 Experimental Treatment 1 Intervention

Group IV: Control bread Active Control 1 Intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

References

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

The acute impact of ingestion of sourdough and whole-grain breads on blood glucose, insulin, and incretins in overweight and obese men. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Sourdough-leavened bread improves postprandial glucose and insulin plasma levels in subjects with impaired glucose tolerance. [2013]

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

Consumption of Sourdough Breads Improves Postprandial Glucose Response and Produces Sourdough-Specific Effects on Biochemical and Inflammatory Parameters and Mineral Absorption. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Multifunctional Bread Rich in Beta Glucans and Low in Starch Improves Metabolic Control in Type 2 Diabetes: A Controlled Trial. [2022]

5. 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]

6. Canada pubmed.ncbi.nlm.nih.gov

The acute impact of the intake of four types of bread on satiety and blood concentrations of glucose, insulin, free fatty acids, triglyceride and acylated ghrelin. A randomized controlled cross-over trial. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Does sourdough bread provide clinically relevant health benefits? [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Distinct Characteristics of Rye and Wheat Breads Impact on Their in Vitro Gastric Disintegration and in Vivo Glucose and Insulin Responses. [2020]