ObesityObesityNCT06288178
The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations
A study testing Bread consumption in people with Obesity and Glycemic Index, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Glycemic Index, Blood Glucose
- What is being tested?
- Bread consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2022to 20 Feb 2023
- 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 35 years
- All sexes
- 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.
- 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.
Who cannot join
- Pregnant,
- lactating women
- patients with physician-diagnosed chronic diseases
- Medication use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Glycemic Index, Blood Glucose, Bread
- Being tested
- Bread consumption
- Keywords
- obesity, Glycemic index, Blood glucose, Cornbread, Buckwheat bread
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread consumptionDietary supplement
There were four groups: whole wheat (WWB), buckwheat (BWB), corn bread (CB) and reference bread.
| Study group | Role | What they receive |
|---|---|---|
| Types of bread | Experimental | 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. Receives: Dietary Supplement: Bread consumption |
| Reference bread (White bread) | Experimental | 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. Receives: Dietary Supplement: Bread consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Within research completion, an average of 4 week
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. 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.
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 posted1 Mar 2024
- Study start19 Dec 2022
- Primary completion20 Jan 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 103 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
- NCT06288178
- Sponsor's protocol ID
- 2022/18
- Acronym
- Obesity
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06288178
- Acronym / sponsor ID
- Obesity / 2022/18
- Conditions
- Obesity, Glycemic Index, Blood Glucose, Bread
- Keywords
- obesity, Glycemic index, Blood glucose, Cornbread, Buckwheat bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 1 Mar 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Types of bread | Experimental | Dietary Supplement: Bread consumptionThe 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. |
| Reference bread (White bread) | Experimental | Dietary Supplement: Bread consumptionControl 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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.
- 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.
Key exclusion criteria (4 listed)
- Pregnant,
- lactating women
- patients with physician-diagnosed chronic diseases
- Medication use
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 |
|---|---|---|
| Bread consumptionThere were four groups: whole wheat (WWB), buckwheat (BWB), corn bread (CB) and reference bread. | Dietary supplement | Reference bread (White bread), Types of bread |
Primary outcome
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
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.
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 1 Mar 2024.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 Bread consumption in people with Obesity and Glycemic Index, 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 4 inclusion and 4 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 1 Mar 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 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.