NCT06925451

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 23, 2026

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

April 6, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

fermentationpre-diabetessourdough breadpost-prandial glycemia

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    blood glucose will be measured using a glucometer and capillary blood from finger prick

    conducted at fasting and 30, 60, 90, and 120 minutes post-meal

Secondary Outcomes (2)

  • hunger rating

    conducted at 120 minutes post-meal

  • bread palatability

    conducted at 120 minutes post-meal

Study Arms (4)

sourdough bread 24

EXPERIMENTAL

24 hours fermentation

Other: sourdough bread 24

Control bread

ACTIVE COMPARATOR

12 hours fermentation

Other: yeast bread

sourdough bread 48

EXPERIMENTAL

48 hours fermentation

Other: sourdough bread 48

sourdough bread 72

EXPERIMENTAL

72 hours fermentation

Other: sourdough bread 72

Interventions

fermentation time=24 hours

sourdough bread 24

fermentation time=48 hours

sourdough bread 48

fermentation time=72 hours

sourdough bread 72

no fermentation

Control bread

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

850 PBC

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Insulin ResistanceGlucose Intolerance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Senior Associate Dean

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 13, 2025

Study Start

April 4, 2025

Primary Completion

August 15, 2025

Study Completion

December 15, 2025

Last Updated

January 23, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

We do not plan to publish in ICMJE journals

Locations