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

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pomegranate Peel
Sponsored by
Toros University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Antioxidant, Obesity, Pomegranate peel, Oxidation, Type 2 Diabetes

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Özlem ÖZPAK AKKUŞ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group

No intervention - Control Group

Arm Description

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.

Individuals with type 2 diabetes will not eat pomegranate crust bread

Outcomes

Primary Outcome Measures

Biochemical Blood Parameters
Examination of between group differences regarding lipid profile
Biochemical Blood Parameters
Examination of between group differences regarding HbA1c
Biochemical Blood Parameters
Examination of between group differences regarding insulin
Biochemical Blood Parameters
Examination of between group differences regarding TAC
Biochemical Blood Parameters
Examination of between group differences regarding TBARS
Anthropometric Measurements - Weight
Examination of between group differences regarding weight in kilogram
Anthropometric Measurements - Height
Examination of between group differences regarding height in meter
Anthropometric Measurements - Body Mass Index
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Anthropometric Measurements - Waist Circumference
Examination of between group differences regarding waist circumference in centimeters
Anthropometric Measurements - Hip Circumference
Examination of between group differences regarding hip circumference in centimeters

Secondary Outcome Measures

Biochemical Blood Parameters
Comparison of between group differences regarding lipid profile
Biochemical Blood Parameters
Comparison of between group differences regarding HbA1c
Biochemical Blood Parameters
Comparison of between group differences regarding insulin
Biochemical Blood Parameters
Comparison of between group differences regarding TAC
Biochemical Blood Parameters
Comparison of between group differences regarding TBARS
Anthropometric Measurements - Weight
Examination of between group differences regarding weight in kilogram
Anthropometric Measurements - Height
Examination of between group differences regarding height in meter
Anthropometric Measurements - Body Mass Index
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Anthropometric Measurements - Waist Circumference
Examination of between group differences regarding waist circumference in centimeters
Anthropometric Measurements - Hip Circumference
Examination of between group differences regarding hip circumference in centimeters

Full Information

First Posted
December 9, 2021
Last Updated
February 8, 2022
Sponsor
Toros University
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1. Study Identification

Unique Protocol Identification Number
NCT05232305
Brief Title
Evaluation of the Effect of Pomegranate Peel Added Bread on Blood Sugar, Fats, and the Body's Defense Response
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toros University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Antioxidant, Obesity, Pomegranate peel, Oxidation, Type 2 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will conduct by using a prospective randomized double-blind clinical trial model.
Masking
ParticipantCare Provider
Masking Description
Participants will not know which type of bread to eat.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention - Control Group
Arm Type
No Intervention
Arm Description
Individuals with type 2 diabetes will not eat pomegranate crust bread
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate Peel
Intervention Description
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).
Primary Outcome Measure Information:
Title
Biochemical Blood Parameters
Description
Examination of between group differences regarding lipid profile
Time Frame
First day at the beginning of the study
Title
Biochemical Blood Parameters
Description
Examination of between group differences regarding HbA1c
Time Frame
First day at the beginning of the study
Title
Biochemical Blood Parameters
Description
Examination of between group differences regarding insulin
Time Frame
First day at the beginning of the study
Title
Biochemical Blood Parameters
Description
Examination of between group differences regarding TAC
Time Frame
First day at the beginning of the study
Title
Biochemical Blood Parameters
Description
Examination of between group differences regarding TBARS
Time Frame
First day at the beginning of the study
Title
Anthropometric Measurements - Weight
Description
Examination of between group differences regarding weight in kilogram
Time Frame
First day at the beginning of the study
Title
Anthropometric Measurements - Height
Description
Examination of between group differences regarding height in meter
Time Frame
First day at the beginning of the study
Title
Anthropometric Measurements - Body Mass Index
Description
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Time Frame
First day at the beginning of the study
Title
Anthropometric Measurements - Waist Circumference
Description
Examination of between group differences regarding waist circumference in centimeters
Time Frame
First day at the beginning of the study
Title
Anthropometric Measurements - Hip Circumference
Description
Examination of between group differences regarding hip circumference in centimeters
Time Frame
First day at the beginning of the study
Secondary Outcome Measure Information:
Title
Biochemical Blood Parameters
Description
Comparison of between group differences regarding lipid profile
Time Frame
Eight weeks after the start of the study
Title
Biochemical Blood Parameters
Description
Comparison of between group differences regarding HbA1c
Time Frame
Eight weeks after the start of the study
Title
Biochemical Blood Parameters
Description
Comparison of between group differences regarding insulin
Time Frame
Eight weeks after the start of the study
Title
Biochemical Blood Parameters
Description
Comparison of between group differences regarding TAC
Time Frame
Eight weeks after the start of the study
Title
Biochemical Blood Parameters
Description
Comparison of between group differences regarding TBARS
Time Frame
Eight weeks after the start of the study
Title
Anthropometric Measurements - Weight
Description
Examination of between group differences regarding weight in kilogram
Time Frame
Eight weeks after the start of the study
Title
Anthropometric Measurements - Height
Description
Examination of between group differences regarding height in meter
Time Frame
Eight weeks after the start of the study
Title
Anthropometric Measurements - Body Mass Index
Description
Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Time Frame
Eight weeks after the start of the study
Title
Anthropometric Measurements - Waist Circumference
Description
Examination of between group differences regarding waist circumference in centimeters
Time Frame
Eight weeks after the start of the study
Title
Anthropometric Measurements - Hip Circumference
Description
Examination of between group differences regarding hip circumference in centimeters
Time Frame
Eight weeks after the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Özlem ÖZPAK AKKUŞ
City
Mersin
State/Province
Yenişehir
ZIP/Postal Code
33100
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özlem ÖZPAK AKKUŞ, Ph.D.
Phone
+905051397978
Email
ozlem.akkus@toros.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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