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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05232305
Enrollment
30
Registered
2022-02-09
Start date
2022-03-01
Completion date
2022-06-01
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Antioxidant, Obesity, Pomegranate peel, Oxidation, Type 2 Diabetes

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.

Interventions

DIETARY_SUPPLEMENTPomegranate 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).

Sponsors

Toros University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participants will not know which type of bread to eat.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anthropometric Measurements - Hip CircumferenceFirst day at the beginning of the studyExamination of between group differences regarding hip circumference in centimeters
Biochemical Blood ParametersFirst day at the beginning of the studyExamination of between group differences regarding lipid profile
Anthropometric Measurements - WeightFirst day at the beginning of the studyExamination of between group differences regarding weight in kilogram
Anthropometric Measurements - HeightFirst day at the beginning of the studyExamination of between group differences regarding height in meter
Anthropometric Measurements - Body Mass IndexFirst day at the beginning of the studyExamination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Anthropometric Measurements - Waist CircumferenceFirst day at the beginning of the studyExamination of between group differences regarding waist circumference in centimeters

Secondary

MeasureTime frameDescription
Biochemical Blood ParametersEight weeks after the start of the studyComparison of between group differences regarding lipid profile
Anthropometric Measurements - WeightEight weeks after the start of the studyExamination of between group differences regarding weight in kilogram
Anthropometric Measurements - HeightEight weeks after the start of the studyExamination of between group differences regarding height in meter
Anthropometric Measurements - Body Mass IndexEight weeks after the start of the studyExamination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)
Anthropometric Measurements - Waist CircumferenceEight weeks after the start of the studyExamination of between group differences regarding waist circumference in centimeters
Anthropometric Measurements - Hip CircumferenceEight weeks after the start of the studyExamination of between group differences regarding hip circumference in centimeters

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026