Diet, HealthyNCT06565676
Effect of Whey Powder Bread on Blood Glucose
A study testing Bread with whey protein powder added in people with Diet, Healthy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Bread with whey protein powder added
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 1 Mar 2025
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having a normal BMI (18.5-25.0 kg/m2),
- being between 19-35 years of age,
- not having any chronic disease,
- not taking any medication, multivitamin or mineral supplements,
- not drinking alcohol or smoking,
- not engaging in heavy physical activity,
- not being pregnant or lactating.
Who cannot join
- having very low and high BMI (<18.5 kg/m2 and >25.0 kg/m2),
- being younger than 19 years and older than 35 years,
- having any chronic disease,
- taking medication, multivitamin or mineral supplements,
- alcohol and smoking, heavy physical activity,
- being pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri, 38039
Aslı ONUR CANAYDIN, MsC, 05320649416, dyt.aslionur@gmail.com
About this study
Official title: Effect of Whey Powder Added Bread on Postprandial Blood Glucose
The aim of the study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. In the study, all volunteer participants will be randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four consecutive days and their blood glucose levels will be measured at certain minutes. There are no studies in the literature investigating the effect of whey powder added to bread on blood glucose.
Read the detailed description
In cheese making, whey is the liquid that is separated from the clot formed as a result of coagulation of milk with rennet or acid, does not coagulate and contains milk dry matter. Serum proteins in whey increase the nutritional value of whey proteins and help the absorption of minerals. In addition to their nutritional value, whey proteins have important health effects in terms of other metabolic functions such as strengthening immunity, stimulating gastrointestinal hormone secretion, antiviral activity, and satiety response. Therefore, the aim of this study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. The study is planned to be conducted in 20 healthy individuals aged 19-35 years with normal body mass index (18.5-25.0 kg/m2) between August 2024 and March 2025. In the study, all volunteer participants will be randomly assigned to a breakfast meal consisting of all bread types (bread made from white flour, bread made from white flour with whey powder added, bread made from whole wheat flour and bread made from whole wheat flour with whey powder added) for four consecutive days. During these days, participants will have their fasting blood glucose measured immediately before the meal containing the test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. After breakfast, postprandial blood glucose will be measured at 15, 30, 45, 60, 90, 120 minutes. Food consumption records will be taken by the researchers and participants will be instructed not to eat or drink anything 8 hours before breakfast and not to perform any physical activity other than their daily activities during that day. Anthropometric measurements will be taken by the researchers using appropriate methods and food consumption records will be questioned in detail on a daily basis. According to the food consumption record, the types and amounts of foods consumed daily will be determined and energy, macro and micronutrient values will be analyzed using the Turkey Specific Nutrition Information System (BeBIS) computer program. There is no study in the literature investigating the effect of whey powder added to bread on blood glucose. In addition, enriching bread, which is very important in the nutrition of the Turkish nation, with whey powder, which is considered as "waste", will contribute to both sustainability and economy.
- Conditions
- Diet, Healthy
- Being tested
- Bread with whey protein powder added
- Keywords
- Whey protein, Blood glucose, Enriched food, Sustainable nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread with whey protein powder addedDietary supplement
Volunteer participants will consume bread with and without whey powder added and its effect on blood sugar will be examined.
| Study group | Role | What they receive |
|---|---|---|
| White Bread | Experimental | Participants will have their fasting blood glucose measured immediately before the meal containing the white flour test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. Receives: Dietary Supplement: Bread with whey protein powder added |
| White Bread with Whey Powder | Experimental | Participants will have their fasting blood glucose measured immediately before the meal containing the white flour with added whey powder test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. Receives: Dietary Supplement: Bread with whey protein powder added |
| Wheat Bread | Experimental | Participants will have their fasting blood glucose measured immediately before the meal containing the wheat flour test bread will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. Receives: Dietary Supplement: Bread with whey protein powder added |
| Wheat Bread with Whey Powder | Experimental | Participants will have their fasting blood glucose measured immediately before the meal containing the wheat flour with added whey powder test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. Receives: Dietary Supplement: Bread with whey protein powder added |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose response
Postprandial glucose response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes. Higher values represent a worse outcome.
Measured: Two hours postprandial period (from fasting to 120 minutes after the test breakfast)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All volunteer participants were randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Aslı Onur Canaydın, TC Erciyes University
- Investigators
- Aslı ONUR CANAYDIN, MsC, Principal investigator, Erciyes Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565676
- Sponsor's protocol ID
- ERU-BD-AOC-01
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Powder Added Bread on Postprandial Blood Glucose
- ClinicalTrials.gov ID
- NCT06565676
- Acronym / sponsor ID
- ERU-BD-AOC-01
- Conditions
- Diet, Healthy
- Keywords
- Whey protein, Blood glucose, Enriched food, Sustainable nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 22 Aug 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 aim of the study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. In the study, all volunteer participants will be randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four consecutive days and their blood glucose levels will be measured at certain minutes. There are no studies in the literature investigating the effect of whey powder added to bread on blood glucose.
Detailed description
In cheese making, whey is the liquid that is separated from the clot formed as a result of coagulation of milk with rennet or acid, does not coagulate and contains milk dry matter. Serum proteins in whey increase the nutritional value of whey proteins and help the absorption of minerals. In addition to their nutritional value, whey proteins have important health effects in terms of other metabolic functions such as strengthening immunity, stimulating gastrointestinal hormone secretion, antiviral activity, and satiety response. Therefore, the aim of this study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. The study is planned to be conducted in 20 healthy individuals aged 19-35 years with normal body mass index (18.5-25.0 kg/m2) between August 2024 and March 2025. In the study, all volunteer participants will be randomly assigned to a breakfast meal consisting of all bread types (bread made from white flour, bread made from white flour with whey powder added, bread made from whole wheat flour and bread made from whole wheat flour with whey powder added) for four consecutive days. During these days, participants will have their fasting blood glucose measured immediately before the meal containing the test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. After breakfast, postprandial blood glucose will be measured at 15, 30, 45, 60, 90, 120 minutes. Food consumption records will be taken by the researchers and participants will be instructed not to eat or drink anything 8 hours before breakfast and not to perform any physical activity other than their daily activities during that day. Anthropometric measurements will be taken by the researchers using appropriate methods and food consumption records will be questioned in detail on a daily basis. According to the food consumption record, the types and amounts of foods consumed daily will be determined and energy, macro and micronutrient values will be analyzed using the Turkey Specific Nutrition Information System (BeBIS) computer program. There is no study in the literature investigating the effect of whey powder added to bread on blood glucose. In addition, enriching bread, which is very important in the nutrition of the Turkish nation, with whey powder, which is considered as "waste", will contribute to both sustainability and economy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- All volunteer participants were randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four days.
| Arm | Type | Receives |
|---|---|---|
| White Bread | Experimental | Dietary Supplement: Bread with whey protein powder addedParticipants will have their fasting blood glucose measured immediately before the meal containing the white flour test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. |
| White Bread with Whey Powder | Experimental | Dietary Supplement: Bread with whey protein powder addedParticipants will have their fasting blood glucose measured immediately before the meal containing the white flour with added whey powder test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. |
| Wheat Bread | Experimental | Dietary Supplement: Bread with whey protein powder addedParticipants will have their fasting blood glucose measured immediately before the meal containing the wheat flour test bread will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. |
| Wheat Bread with Whey Powder | Experimental | Dietary Supplement: Bread with whey protein powder addedParticipants will have their fasting blood glucose measured immediately before the meal containing the wheat flour with added whey powder test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- having a normal BMI (18.5-25.0 kg/m2),
- being between 19-35 years of age,
- not having any chronic disease,
- not taking any medication, multivitamin or mineral supplements,
- not drinking alcohol or smoking,
Key exclusion criteria (6 listed)
- having very low and high BMI (<18.5 kg/m2 and >25.0 kg/m2),
- being younger than 19 years and older than 35 years,
- having any chronic disease,
- taking medication, multivitamin or mineral supplements,
- alcohol and smoking, heavy physical activity,
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 with whey protein powder addedVolunteer participants will consume bread with and without whey powder added and its effect on blood sugar will be examined. | Dietary supplement | Wheat Bread, Wheat Bread with Whey Powder, White Bread, White Bread with Whey Powder |
Primary outcome
Postprandial glucose response
Time frame: Two hours postprandial period (from fasting to 120 minutes after the test breakfast)
Postprandial glucose response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes. Higher values represent a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Aslı ONUR CANAYDIN, MsC principal investigator
Erciyes Üniversitesi
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 with whey protein powder added in people with Diet, Healthy, run by TC Erciyes 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aslı ONUR CANAYDIN, MsC (05320649416, dyt.aslionur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose response (time frame: Two hours postprandial period (from fasting to 120 minutes after the test breakfast)). 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 26 Aug 2024.