- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06288178
The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations (Obesity)
February 24, 2024 updated by: Fatih Cesur, Ege University
The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations in Individuals With Obesity and Normal-Weight: A Randomized Controlled Trial
The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).
Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trabzon, Turkey, 61000
- Avrasya University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The study group consisted of volunteer individuals aged between 18 and 35 years.
- The first blood glucose measurement was taken after at least 8 hours of fasting and any of the bread types were given to the participants for consumption.
- All measurements were taken between 09.00-13.00.
- During the measurements, the volunteers were observed to avoid water, coffee, and any food intake and to avoid excessive exercise.
Exclusion Criteria:
- Pregnant,
- lactating women
- patients with physician-diagnosed chronic diseases
- Medication use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Types of bread
The three breads (whole wheat bread, buckwheat bread, and cornmeal bread) contained 30 grams of digestible carbohydrates.
Participants consumed these breads when they were hungry.
Blood glucose was measured with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes.
Anthropometric measurements were measured by BIA method and weight classification (obesity and normal weight) was made.
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There were four groups: whole wheat (WWB), buckwheat (BWB), corn bread (CB) and reference bread.
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Experimental: Reference bread (White bread)
Control group.
Blood glucose comparison of all breads was determined according to white bread.
The measurement method used was the same as for the other breads.
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There were four groups: whole wheat (WWB), buckwheat (BWB), corn bread (CB) and reference bread.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption.
Time Frame: Within research completion, an average of 4 week
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The effect of loaves of bread with a high glycemic index on blood sugar is well known.
The higher the glycemic index, the higher the blood sugar fluctuation.
Glycemic index values should be lower than white bread.
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Within research completion, an average of 4 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week.
Time Frame: Within research completion, an average of 1 week
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It is known that high glycemic index values of bread consumption are paralleled by high blood fluctuations.
On the other hand, the impact of bread consumption on obesity and normal weight people is also of interest.
In obese people, the high glycemic index predisposes them to overeating.
It can be said that the consumption of whole wheat bread caused lower blood glucose fluctuations than white bread, and on top of that, corn bread caused lower changes in blood glucose fluctuations than other breads in obese individuals.
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Within research completion, an average of 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
February 20, 2023
Study Registration Dates
First Submitted
February 17, 2024
First Submitted That Met QC Criteria
February 24, 2024
First Posted (Actual)
March 1, 2024
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 24, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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