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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05232305
• Other study ID #: Pomegranatepeelintype2DM
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2022
• Source: Toros University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• 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 AKKUS 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).

Locations

Country	Name	City	State
Turkey	Özlem ÖZPAK AKKUS	Mersin	Yenisehir

Sponsors (1)

Lead Sponsor	Collaborator
Toros University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Blood Parameters	Examination of between group differences regarding lipid profile	First day at the beginning of the study
Primary	Biochemical Blood Parameters	Examination of between group differences regarding HbA1c	First day at the beginning of the study
Primary	Biochemical Blood Parameters	Examination of between group differences regarding insulin	First day at the beginning of the study
Primary	Biochemical Blood Parameters	Examination of between group differences regarding TAC	First day at the beginning of the study
Primary	Biochemical Blood Parameters	Examination of between group differences regarding TBARS	First day at the beginning of the study
Primary	Anthropometric Measurements - Weight	Examination of between group differences regarding weight in kilogram	First day at the beginning of the study
Primary	Anthropometric Measurements - Height	Examination of between group differences regarding height in meter	First day at the beginning of the study
Primary	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
Primary	Anthropometric Measurements - Waist Circumference	Examination of between group differences regarding waist circumference in centimeters	First day at the beginning of the study
Primary	Anthropometric Measurements - Hip Circumference	Examination of between group differences regarding hip circumference in centimeters	First day at the beginning of the study
Secondary	Biochemical Blood Parameters	Comparison of between group differences regarding lipid profile	Eight weeks after the start of the study
Secondary	Biochemical Blood Parameters	Comparison of between group differences regarding HbA1c	Eight weeks after the start of the study
Secondary	Biochemical Blood Parameters	Comparison of between group differences regarding insulin	Eight weeks after the start of the study
Secondary	Biochemical Blood Parameters	Comparison of between group differences regarding TAC	Eight weeks after the start of the study
Secondary	Biochemical Blood Parameters	Comparison of between group differences regarding TBARS	Eight weeks after the start of the study
Secondary	Anthropometric Measurements - Weight	Examination of between group differences regarding weight in kilogram	Eight weeks after the start of the study
Secondary	Anthropometric Measurements - Height	Examination of between group differences regarding height in meter	Eight weeks after the start of the study
Secondary	Anthropometric Measurements - Body Mass Index	Examination of between group differences regarding body mass index (BMI = weight in kilogram / height in meter 2)	Eight weeks after the start of the study
Secondary	Anthropometric Measurements - Waist Circumference	Examination of between group differences regarding waist circumference in centimeters	Eight weeks after the start of the study
Secondary	Anthropometric Measurements - Hip Circumference	Examination of between group differences regarding hip circumference in centimeters	Eight weeks after the start of the study