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

NCT05232305 | Unknown DMC

• 1 other identifier: Pomegranatepeelintype2DM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Biochemical Blood Parameters

  Examination of between group differences regarding lipid profile

  First day at the beginning of the study

• Biochemical Blood Parameters

  Examination of between group differences regarding HbA1c

  First day at the beginning of the study

• Biochemical Blood Parameters

  Examination of between group differences regarding insulin

  First day at the beginning of the study

• Biochemical Blood Parameters

  Examination of between group differences regarding TAC

  First day at the beginning of the study

• Biochemical Blood Parameters

  Examination of between group differences regarding TBARS

  First day at the beginning of the study

• Anthropometric Measurements - Weight

  Examination of between group differences regarding weight in kilogram

  First day at the beginning of the study

• Anthropometric Measurements - Height

  Examination of between group differences regarding height in meter

  First day at the beginning of the study

• Anthropometric Measurements - Body Mass Index

  Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)

  First day at the beginning of the study

• Anthropometric Measurements - Waist Circumference

  Examination of between group differences regarding waist circumference in centimeters

  First day at the beginning of the study

• Anthropometric Measurements - Hip Circumference

  Examination of between group differences regarding hip circumference in centimeters

  First day at the beginning of the study

Secondary Outcomes (10)

• Biochemical Blood Parameters

  Eight weeks after the start of the study

• Biochemical Blood Parameters

  Eight weeks after the start of the study

• Biochemical Blood Parameters

  Eight weeks after the start of the study

• Biochemical Blood Parameters

  Eight weeks after the start of the study

• Biochemical Blood Parameters

  Eight weeks after the start of the study

Study Arms (2)

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

EXPERIMENTAL

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.

Dietary Supplement: Pomegranate Peel

No intervention - Control Group

NO INTERVENTION

Individuals with type 2 diabetes will not eat pomegranate crust bread

Interventions

Pomegranate Peel 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).

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

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Özlem ÖZPAK AKKUŞ

Mersin, Yenişehir, 33100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will not know which type of bread to eat.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 9, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: data can be shared after the research is published in consultation with the principal investigator.
• Access Criteria: data can be shared after the research is published in consultation with the principal investigator.

Locations

TU (1)