Effects of Sourdough Fermentation Duration and Acid Development on Postprandial Blood Glucose in Prediabetic Adults

NCT ID: NCT06925451

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Sourdough bread has been proven to have higher fiber content and contains beneficial microorganisms from the fermentation process and has been linked to reduced risk of various diseases like diabetes, cardiovascular disease, and dyslipidemia. The fermentation of sourdough bread products converts starch and sugar in the dough into resistant starches and other slower digesting compounds. Sourdough bread products also have a lower glycemic index value, meaning they do not cause the blood sugar to rise as quickly, thus slowing the release of insulin in the body, leading to reduced risk of insulin resistance. However, very few studies exist studying the effects of naturally fermented sourdough products in individuals with prediabetes. It is worth exploring if increasing the fermentation time of naturally fermented sourdough bread increases the effects on relevant biomarkers relating to postprandial glycemia and insulinemia in prediabetic adults.

This study examined the acute effect of varying lengths of sourdough fermentation times on postprandial blood glucose levels over a 4-week period in adults with prediabetes (as evidenced by fasting glucose ≥100 or diagnosis by physician), but not taking diabetic medications. For each trial, the sourdough bread was ingested after an overnight fasting period in order to evaluate the effects of the bread when incorporated into the diet in place of breads made with baker's yeast. The goal of this crossover randomized trial was to assess the relationship between lengthened fermentation time, meaning an increased amount of lactic acid and acetic acid in the bread product, and glycemic and insulinemic response.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The day prior to testing is standardized: no vigorous activity or alcohol consumption, and two bagels are to be consumed between 3 pm and 8 pm. Participants will begin an overnight fast starting around 10 pm (only water is to be consumed). The bagels will be provided at no charge. For each of the 4 test visits, participants arrive in a fasted state and a blood drop will be collected via finger prick to measure glucose. The 'test meal' will be consumed under observation within 8 minutes. The three fermented versions on the sourdough bread and the control bread will be fed using a four-block randomization process. Finger pricks will take place at 30, 60, 90, and 120 minutes post meal. The participant will be asked to complete hunger measures and report on the acceptability of the bread at the completion of testing.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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sourdough bread 24

24 hours fermentation

Group Type EXPERIMENTAL

sourdough bread 24

Intervention Type OTHER

fermentation time=24 hours

Control bread

12 hours fermentation

Group Type ACTIVE_COMPARATOR

yeast bread

Intervention Type OTHER

no fermentation

sourdough bread 48

48 hours fermentation

Group Type EXPERIMENTAL

sourdough bread 48

Intervention Type OTHER

fermentation time=48 hours

sourdough bread 72

72 hours fermentation

Group Type EXPERIMENTAL

sourdough bread 72

Intervention Type OTHER

fermentation time=72 hours

Interventions

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sourdough bread 24

fermentation time=24 hours

Intervention Type OTHER

sourdough bread 48

fermentation time=48 hours

Intervention Type OTHER

sourdough bread 72

fermentation time=72 hours

Intervention Type OTHER

yeast bread

no fermentation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* prediabetes; not on metformin; no known food allergies or sensitivities; not supplementing pre/post biotics

Exclusion Criteria

* following diet that restricts carbohydrates; medication use affecting blood glucose; acute illness; smoker; pregnant; lactating; GI tract surgery; not willing to follow protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Carol Johnston

Professor and Senior Associate Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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850 PBC

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carol Johnston, PhD

Role: CONTACT

6024962539

Facility Contacts

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Carol Johnston

Role: primary

602-496-2539

Other Identifiers

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STUDY00021470

Identifier Type: -

Identifier Source: org_study_id

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