- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925451
Effects of Sourdough Fermentation Duration and Acid Development on Postprandial Blood Glucose in Prediabetic Adults
Effects of Natural Sourdough Fermentation Duration and Acid Development on Postprandial Blood Glucose in Prediabetic Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- 850 PBC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: sourdough bread 24
24 hours fermentation
|
fermentation time=24 hours
|
|
Active Comparator: Control bread
12 hours fermentation
|
no fermentation
|
|
Experimental: sourdough bread 48
48 hours fermentation
|
fermentation time=48 hours
|
|
Experimental: sourdough bread 72
72 hours fermentation
|
fermentation time=72 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood glucose
Time Frame: conducted at fasting and 30, 60, 90, and 120 minutes post-meal
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bread palatability
Time Frame: conducted at 120 minutes post-meal
|
bread palatability will be measured by Likert scale
|
conducted at 120 minutes post-meal
|
|
hunger rating
Time Frame: conducted at 120 minutes post-meal
|
Hunger rating will be determined using Likert scale.
Anchors: not hungry at all and as hungry as I have ever felt.
A higher score indicates greater hunger.
|
conducted at 120 minutes post-meal
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00021470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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