ObesityHazelnutNCT06382506
The Effect of Hazelnut Flour on Blood Glucose
A study testing Consumption of Cornbread with Hazelnut Bread in people with Obesity and Celiac Disease, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Celiac Disease, Blood Glucose
- What is being tested?
- Consumption of Cornbread with Hazelnut Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2024to 21 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant,
- lactating women
- patients with physician-diagnosed chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Celiac Disease, Blood Glucose, Flour Sensitivity
- Being tested
- Consumption of Cornbread with Hazelnut Bread
- Keywords
- Obesity, Celiac Disease, Blood glucose, Flour Sensitivity
- Medical subject headings
- Obesity, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of Cornbread with Hazelnut BreadDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| The effect of cornbread consumption blood glucose fluctuations in participants. | Experimental | 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. Receives: Dietary Supplement: Consumption of Cornbread with Hazelnut Bread |
| The effect of cornbread with hazelnut bread consumption blood glucose fluctuations in participants. | Experimental | 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. Receives: Dietary Supplement: Consumption of Cornbread with Hazelnut Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Within research completion, an average of a month
Secondary outcomes (1)
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.
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.
Measured: Within research completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start21 Mar 2024
- Primary completion21 Apr 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Cesur, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382506
- Sponsor's protocol ID
- 2024/138
- Acronym
- Hazelnut
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cesur F, Uygur B. Can hazelnut flour added to gluten-free corn flour in different amounts cause differences in blood glucose fluctuations? Int J Food Sci Nutr. 2025 Feb;76(1):84-92. doi: 10.1080/09637486.2024.2435841. Epub 2024 Dec 3.
PubMed 39627012
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Hazelnut Flour Added to Gluten-free Corn Flour in Different Amounts Cause Differences in Blood Glucose Fluctuations?
- ClinicalTrials.gov ID
- NCT06382506
- Acronym / sponsor ID
- Hazelnut / 2024/138
- Conditions
- Obesity, Celiac Disease, Blood Glucose, Flour Sensitivity
- Keywords
- Obesity, Celiac Disease, Blood glucose, Flour Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effect of cornbread consumption blood glucose fluctuations in participants. | Experimental | Dietary Supplement: Consumption of Cornbread with Hazelnut BreadThe 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. |
| The effect of cornbread with hazelnut bread consumption blood glucose fluctuations in participants. | Experimental | Dietary Supplement: Consumption of Cornbread with Hazelnut BreadThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant,
- lactating women
- patients with physician-diagnosed chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption of Cornbread with Hazelnut BreadCornbread 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. | Dietary supplement | The effect of cornbread consumption blood glucose fluctuations in participants., The effect of cornbread with hazelnut bread consumption blood glucose fluctuations in participants. |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 39627012Cesur F, Uygur B. Can hazelnut flour added to gluten-free corn flour in different amounts cause differences in blood glucose fluctuations? Int J Food Sci Nutr. 2025 Feb;76(1):84-92. doi: 10.1080/09637486.2024.2435841. Epub 2024 Dec 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of Cornbread with Hazelnut Bread in people with Obesity and Celiac Disease, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.