- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06382506
The Effect of Hazelnut Flour on Blood Glucose (Hazelnut)
April 21, 2024 updated by: Fatih Cesur, Ege University
Can Hazelnut Flour Added to Gluten-free Corn Flour in Different Amounts Cause Differences in Blood Glucose Fluctuations?
One of the factors affecting human health is nutrition.
The effects of foods on blood glucose are still under investigation.
The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose.
It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics.
It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
-
Trabzon, Turkey, 61000
- Avrasya University
-
-
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.
- 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
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: The effect of cornbread consumption blood glucose fluctuations in participants.
The bread contained 50 grams of digestible carbohydrates.
Participants consumed these loaves of bread when they were hungry.
Blood glucose measurements were taken at 0 (fasting),15, 30, 45, 60, 90, and 120 minutes.
|
Cornbread was added to 15 grams and 30 grams of bread and consumed by the participants.
Blood glucose levels were then measured.
Obese and normal-weight individuals will be divided into two groups according to their anthropometric measurements.
|
|
Experimental: The effect of cornbread with hazelnut bread consumption blood glucose fluctuations in participants.
The bread contained 50 grams of digestible carbohydrates.
Participants consumed these loaves of bread when they were hungry.
Blood glucose measurements were taken at 0 (fasting),15, 30, 45, 60, 90, and 120 minutes.
|
Cornbread was added to 15 grams and 30 grams of bread and consumed by the participants.
Blood glucose levels were then measured.
Obese and normal-weight individuals will be divided into two groups according to their anthropometric measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption.
Time Frame: Within research completion, an average of a month
|
The effect of loaves of bread with a high glycemic index on blood glucose is well known.
The higher the glycemic index, the higher the blood glucose fluctuation.
Glycemic index values should be lower than white bread.
Consumption of hazelnut flour rich in fatty acids and fiber should show a positive change in blood glucose.
|
Within research completion, an average of a month
|
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
|
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.
As the amount of hazelnut flour in bread increases, there is a positive change in blood glucose fluctuations in individuals.
|
Within research completion, an average of 1 week
|
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)
March 21, 2024
Primary Completion (Actual)
April 21, 2024
Study Completion (Actual)
April 21, 2024
Study Registration Dates
First Submitted
February 17, 2024
First Submitted That Met QC Criteria
April 21, 2024
First Posted (Actual)
April 24, 2024
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 21, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/138
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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