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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Pomegranate Peel

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yenişehir
    • Mersin, Yenişehir, Turkey, 33100
      • Özlem ÖZPAK AKKUŞ
      • Contact: Özlem ÖZPAK AKKUŞ, Ph.D.; Phone Number: +905051397978; Email: ozlem.akkus@toros.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group; 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; 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).
No Intervention: No intervention - Control Group; Individuals with type 2 diabetes will not eat pomegranate crust bread

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Toros University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Type 2 Diabetes; Antioxidant; Pomegranate peel; Oxidation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pomegranatepeelintype2DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data can be shared in consultation with the principal investigator.
• IPD Sharing Time Frame: data can be shared after the research is published in consultation with the principal investigator.
• IPD Sharing Access Criteria: data can be shared after the research is published in consultation with the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No