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

NCT ID: NCT05232305

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-06-01

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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will conduct by using a prospective randomized double-blind clinical trial model.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Participants will not know which type of bread to eat.

Study Groups

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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.

Group Type EXPERIMENTAL

Pomegranate Peel

Intervention Type DIETARY_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).

No intervention - Control Group

Individuals with type 2 diabetes will not eat pomegranate crust bread

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toros University

OTHER

Sponsor Role lead

Responsible Party

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Özlem ÖZPAK AKKUŞ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Özlem ÖZPAK AKKUŞ

Mersin, Yenişehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Özlem ÖZPAK AKKUŞ, Ph.D.

Role: primary

+905051397978

Other Identifiers

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Pomegranatepeelintype2DM

Identifier Type: -

Identifier Source: org_study_id

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