Type 2 DiabetesNCT05232305
Evaluation of the Effect of Pomegranate Peel Added Bread on Blood Sugar, Fats, and the Body's Defense Response
A study testing Pomegranate Peel in people with Type 2 Diabetes, run by Toros University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of the consumption of bread produced with the addition of pomegranate peels, which has a high antioxidant content, on blood glucose and lipid parameters, and some oxidant-antioxidant enzymes and lipid peroxidation in individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pomegranate Peel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jun 2022
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with type 2 diabetes for at least 5 years,
- Using only oral antidiabetic
- With a Body Mass Index (BMI) value ≥ 25.0 kg/m2,
- Signing the Informed Voluntary Consent Form,
- Being in an age range of 19-64 years.
Who cannot join
- Having kidney, liver, and inflammatory diseases,
- Being on insulin therapy,
- Using prescription drugs and/or fiber supplements,
- Taking vitamin and mineral supplements,
- Being pregnant/lactating,
- Consuming excessive alcohol (>2 drinks/day),
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- Being in the menstrual period,
- Receiving gluten enteropathy,
- Having allergy against pomegranate.
- In addition, individuals with Covid-19-related condition during the study process will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Özlem ÖZPAK AKKUŞ
Mersin, Yenişehir, 33100
Özlem ÖZPAK AKKUŞ, Ph.D., +905051397978, ozlem.akkus@toros.edu.tr
About this study
Official title: Evaluation of the Effect of Pomegranate Peel on Plasma Glucose, Lipid Parameters, and Lipid Oxidation in Individuals With Type 2 Diabetes: A Randomized Controlled Study
The aim of this study is to evaluate the effects of the consumption of bread produced with the addition of pomegranate peels, which has a high antioxidant content, on blood glucose and lipid parameters, and some oxidant-antioxidant enzymes and lipid peroxidation in individuals with type 2 diabetes.
Read the detailed description
Between 01.02.2022 and 30.05.2022 with Specialist Dr. Emel SENOL's approval, by Specialist Dr. Akkız Zuhal ÖZTAŞ
The study will be conducted with 30 volunteers who present to the City Hospital Internal Medicine Polyclinic in Mersin.
- Conditions
- Type 2 Diabetes
- Being tested
- Pomegranate Peel
- Keywords
- Antioxidant, Obesity, Pomegranate peel, Oxidation, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate PeelDietary supplement
Standard bread and test breads (with added pomegranate peel) to be used in the study will be produced by Asst. Prof. Özlem ÖZPAK AKKUŞ in the Nutrition Principles Laboratory of Toros University. For standard bread, 900 ml of water, 42 fresh yeast, 12 g of salt and 12 g of sunflower oil will be added to 1000 g of sifted whole wheat flour and the prepared bread mixture will be divided into 40 equal parts. To make bread with pomegranate peel added, 1000 g of sifted whole wheat flour, 20 g of pomegranate peel powder, 914 ml of water, 42 g of fresh yeast, 12 g of salt and 12 g of sunflower oil will be added and the prepared bread mixture is divided into 40 equal parts with 500 mg of pomegranate peel powder in each piece).
| Study group | Role | What they receive |
|---|---|---|
| People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group | Experimental | Individuals with type 2 diabetes who met the inclusion criteria and participated in the study will divided into two groups by Specialist Akkız Zuhal ÖZTAŞ and Specialist Doctor Emel ŞENOL, and they will be asked to consume the breads produced (in the preliminary study) produced as a standard (n=15) and with the addition of pomegranate peel (n=15) for eight weeks.
The individuals participating in the study will be asked not to change their eating habits, physical activity habits, and drug treatments during the study period. Each individual participating in the study will be provided with the required amount of bread during the study and will be contacted weekly by Zeynep ÇAMLIK, a specialist dietitian, to verify whether they consume bread regularly. Receives: Dietary Supplement: Pomegranate Peel |
| No intervention - Control Group | No intervention | Individuals with type 2 diabetes will not eat pomegranate crust bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Blood Parameters
Examination of between group differences regarding lipid profile
Measured: First day at the beginning of the study
Biochemical Blood Parameters
Examination of between group differences regarding HbA1c
Measured: First day at the beginning of the study
Biochemical Blood Parameters
Examination of between group differences regarding insulin
Measured: First day at the beginning of the study
Biochemical Blood Parameters
Examination of between group differences regarding TAC
Measured: First day at the beginning of the study
Biochemical Blood Parameters
Examination of between group differences regarding TBARS
Measured: First day at the beginning of the study
Anthropometric Measurements - Weight
Examination of between group differences regarding weight in kilogram
Measured: First day at the beginning of the study
Anthropometric Measurements - Height
Examination of between group differences regarding height in meter
Measured: First day at the beginning of the study
Anthropometric Measurements - Body Mass Index
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Measured: First day at the beginning of the study
Anthropometric Measurements - Waist Circumference
Examination of between group differences regarding waist circumference in centimeters
Measured: First day at the beginning of the study
Anthropometric Measurements - Hip Circumference
Examination of between group differences regarding hip circumference in centimeters
Measured: First day at the beginning of the study
Secondary outcomes (10)
Biochemical Blood Parameters
Comparison of between group differences regarding lipid profile
Measured: Eight weeks after the start of the study
Biochemical Blood Parameters
Comparison of between group differences regarding HbA1c
Measured: Eight weeks after the start of the study
Biochemical Blood Parameters
Comparison of between group differences regarding insulin
Measured: Eight weeks after the start of the study
Biochemical Blood Parameters
Comparison of between group differences regarding TAC
Measured: Eight weeks after the start of the study
Biochemical Blood Parameters
Comparison of between group differences regarding TBARS
Measured: Eight weeks after the start of the study
Anthropometric Measurements - Weight
Examination of between group differences regarding weight in kilogram
Measured: Eight weeks after the start of the study
Anthropometric Measurements - Height
Examination of between group differences regarding height in meter
Measured: Eight weeks after the start of the study
Anthropometric Measurements - Body Mass Index
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Measured: Eight weeks after the start of the study
Anthropometric Measurements - Waist Circumference
Examination of between group differences regarding waist circumference in centimeters
Measured: Eight weeks after the start of the study
Anthropometric Measurements - Hip Circumference
Examination of between group differences regarding hip circumference in centimeters
Measured: Eight weeks after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Model description
- The study will conduct by using a prospective randomized double-blind clinical trial model.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZPAK AKKUŞ, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232305
- Sponsor's protocol ID
- Pomegranatepeelintype2DM
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared in consultation with the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pomegranate Peel on Plasma Glucose, Lipid Parameters, and Lipid Oxidation in Individuals With Type 2 Diabetes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05232305
- Acronym / sponsor ID
- Pomegranatepeelintype2DM
- Conditions
- Type 2 Diabetes
- Keywords
- Antioxidant, Obesity, Pomegranate peel, Oxidation, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 9 Feb 2022 (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 this study is to evaluate the effects of the consumption of bread produced with the addition of pomegranate peels, which has a high antioxidant content, on blood glucose and lipid parameters, and some oxidant-antioxidant enzymes and lipid peroxidation in individuals with type 2 diabetes.
Detailed description
Between 01.02.2022 and 30.05.2022 with Specialist Dr. Emel SENOL's approval, by Specialist Dr. Akkız Zuhal ÖZTAŞ
The study will be conducted with 30 volunteers who present to the City Hospital Internal Medicine Polyclinic in Mersin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study will conduct by using a prospective randomized double-blind clinical trial model.
| Arm | Type | Receives |
|---|---|---|
| People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group | Experimental | Dietary Supplement: Pomegranate PeelIndividuals with type 2 diabetes who met the inclusion criteria and participated in the study will divided into two groups by Specialist Akkız Zuhal ÖZTAŞ and Specialist Doctor Emel ŞENOL, and they will be asked to consume the breads produced (in the preliminary study) produced as a standard (n=15) and with the addition of pomegranate peel (n=15) for eight weeks. The individuals participating in the study will be asked not to change their eating habits, physical activity habits, and drug treatments during the study period. Each individual participating in the study will be provided with the required amount of bread during the study and will be contacted weekly by Zeynep ÇAMLIK, a specialist dietitian, to verify whether they consume bread regularly. |
| No intervention - Control Group | No intervention | –Individuals with type 2 diabetes will not eat pomegranate crust bread |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being diagnosed with type 2 diabetes for at least 5 years,
- Using only oral antidiabetic
- With a Body Mass Index (BMI) value ≥ 25.0 kg/m2,
- Signing the Informed Voluntary Consent Form,
- Being in an age range of 19-64 years.
Key exclusion criteria (10 listed)
- Having kidney, liver, and inflammatory diseases,
- Being on insulin therapy,
- Using prescription drugs and/or fiber supplements,
- Taking vitamin and mineral supplements,
- Being pregnant/lactating,
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 |
|---|---|---|
| Pomegranate PeelStandard bread and test breads (with added pomegranate peel) to be used in the study will be produced by Asst. Prof. Özlem ÖZPAK AKKUŞ in the Nutrition Principles Laboratory of Toros University. For standard bread, 900 ml of water, 42 fresh yeast, 12 g of salt and 12 g of sunflower oil will be added to 1000 g of sifted whole wheat flour and the prepared bread mixture will be divided into 40 equal parts. To make bread with pomegranate peel added, 1000 g of sifted whole wheat flour, 20 g of pomegranate peel powder, 914 ml of water, 42 g of fresh yeast, 12 g of salt and 12 g of sunflower oil will be added and the prepared bread mixture is divided into 40 equal parts with 500 mg of pomegranate peel powder in each piece). | Dietary supplement | People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group |
Primary outcome
Biochemical Blood Parameters
Time frame: First day at the beginning of the study
Examination of between group differences regarding lipid profile
Biochemical Blood Parameters
Time frame: First day at the beginning of the study
Examination of between group differences regarding HbA1c
Biochemical Blood Parameters
Time frame: First day at the beginning of the study
Examination of between group differences regarding insulin
Biochemical Blood Parameters
Time frame: First day at the beginning of the study
Examination of between group differences regarding TAC
Biochemical Blood Parameters
Time frame: First day at the beginning of the study
Examination of between group differences regarding TBARS
Anthropometric Measurements - Weight
Time frame: First day at the beginning of the study
Examination of between group differences regarding weight in kilogram
Anthropometric Measurements - Height
Time frame: First day at the beginning of the study
Examination of between group differences regarding height in meter
Anthropometric Measurements - Body Mass Index
Time frame: First day at the beginning of the study
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Anthropometric Measurements - Waist Circumference
Time frame: First day at the beginning of the study
Examination of between group differences regarding waist circumference in centimeters
Anthropometric Measurements - Hip Circumference
Time frame: First day at the beginning of the study
Examination of between group differences regarding hip circumference in centimeters
10 secondary outcomes
Biochemical Blood Parameters
Time frame: Eight weeks after the start of the study
Biochemical Blood Parameters
Time frame: Eight weeks after the start of the study
Biochemical Blood Parameters
Time frame: Eight weeks after the start of the study
Biochemical Blood Parameters
Time frame: Eight weeks after the start of the study
Biochemical Blood Parameters
Time frame: Eight weeks after the start of the study
Anthropometric Measurements - Weight
Time frame: Eight weeks after the start of the study
Anthropometric Measurements - Height
Time frame: Eight weeks after the start of the study
Anthropometric Measurements - Body Mass Index
Time frame: Eight weeks after the start of the study
Anthropometric Measurements - Waist Circumference
Time frame: Eight weeks after the start of the study
Anthropometric Measurements - Hip Circumference
Time frame: Eight weeks after the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: Yes. Data can be shared in consultation with the principal investigator.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate Peel in people with Type 2 Diabetes, run by Toros 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 5 inclusion and 10 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 9 Feb 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Blood Parameters (time frame: First day at the beginning of the study). The study lists 10 primary outcomes in all. 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 9 Feb 2022.