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

T

Toros University

Status

Unknown

Conditions

Type 2 Diabetes

Treatments

Dietary Supplement: Pomegranate Peel

Study type

Interventional

Funder types

Other

Identifiers

NCT05232305
Pomegranatepeelintype2DM

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

19 to 64 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group
Experimental group
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.
Treatment:
Dietary Supplement: Pomegranate Peel
No intervention - Control Group
No Intervention group
Description:
Individuals with type 2 diabetes will not eat pomegranate crust bread

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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