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

Not Applicable
Conditions
Type 2 Diabetes
Interventions
Dietary Supplement: Pomegranate Peel
Registration Number
NCT05232305
Lead Sponsor
Toros University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
People with type 2 diabetes who eat bread with pomegranate crust - Experimental GroupPomegranate PeelIndividuals 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.
Primary Outcome Measures
NameTimeMethod
Biochemical Blood ParametersFirst day at the beginning of the study

Examination of between group differences regarding TBARS

Anthropometric Measurements - WeightFirst day at the beginning of the study

Examination of between group differences regarding weight in kilogram

Anthropometric Measurements - HeightFirst day at the beginning of the study

Examination of between group differences regarding height in meter

Anthropometric Measurements - Body Mass IndexFirst day at the beginning of the study

Examination 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 study

Examination of between group differences regarding waist circumference in centimeters

Anthropometric Measurements - Hip CircumferenceFirst day at the beginning of the study

Examination of between group differences regarding hip circumference in centimeters

Secondary Outcome Measures
NameTimeMethod
Biochemical Blood ParametersEight weeks after the start of the study

Comparison of between group differences regarding TBARS

Anthropometric Measurements - WeightEight weeks after the start of the study

Examination of between group differences regarding weight in kilogram

Anthropometric Measurements - HeightEight weeks after the start of the study

Examination of between group differences regarding height in meter

Anthropometric Measurements - Body Mass IndexEight weeks after the start of the study

Examination 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 study

Examination of between group differences regarding waist circumference in centimeters

Anthropometric Measurements - Hip CircumferenceEight weeks after the start of the study

Examination of between group differences regarding hip circumference in centimeters

Trial Locations

Locations (1)

Özlem ÖZPAK AKKUŞ

🇹🇷

Mersin, Yenişehir, Turkey

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