Evaluation of the Effect of Pomegranate Peel Added Bread on Blood Sugar, Fats, and the Body's Defense Response

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Pomegranate Peel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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), 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will conduct by using a prospective randomized double-blind clinical trial model.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group<br>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. | Dietary Supplement: Pomegranate Peel<br>* 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).<br>|
| No Intervention: No intervention - Control Group<br>Individuals with type 2 diabetes will not eat pomegranate crust bread | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Blood Parameters | Examination of between group differences regarding lipid profile | First day at the beginning of the study | 
| Biochemical Blood Parameters | Examination of between group differences regarding HbA1c | First day at the beginning of the study | 
| Biochemical Blood Parameters | Examination of between group differences regarding insulin | First day at the beginning of the study | 
| Biochemical Blood Parameters | Examination of between group differences regarding TAC | First day at the beginning of the study | 
| Biochemical Blood Parameters | Examination of between group differences regarding TBARS | First day at the beginning of the study | 
| Anthropometric Measurements - Weight | Examination of between group differences regarding weight in kilogram | First day at the beginning of the study | 
| Anthropometric Measurements - Height | Examination of between group differences regarding height in meter | 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) | First day at the beginning of the study | 
| Anthropometric Measurements - Waist Circumference | Examination of between group differences regarding waist circumference in centimeters | First day at the beginning of the study | 
| Anthropometric Measurements - Hip Circumference | Examination of between group differences regarding hip circumference in centimeters | First day at the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Blood Parameters | Comparison of between group differences regarding lipid profile | Eight weeks after the start of the study | 
| Biochemical Blood Parameters | Comparison of between group differences regarding HbA1c | Eight weeks after the start of the study | 
| Biochemical Blood Parameters | Comparison of between group differences regarding insulin | Eight weeks after the start of the study | 
| Biochemical Blood Parameters | Comparison of between group differences regarding TAC | Eight weeks after the start of the study | 
| Biochemical Blood Parameters | Comparison of between group differences regarding TBARS | Eight weeks after the start of the study | 
| Anthropometric Measurements - Weight | Examination of between group differences regarding weight in kilogram | Eight weeks after the start of the study | 
| Anthropometric Measurements - Height | Examination of between group differences regarding height in meter | 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) | Eight weeks after the start of the study | 
| Anthropometric Measurements - Waist Circumference | Examination of between group differences regarding waist circumference in centimeters | Eight weeks after the start of the study | 
| Anthropometric Measurements - Hip Circumference | Examination of between group differences regarding hip circumference in centimeters | Eight weeks after the start of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, Obesity, Pomegranate peel, Oxidation, Type 2 Diabetes