Clinical trial NCT05232305: Evaluation of the Effect of Pomegranate Peel Added Bread on Blood Sugar, Fats, and the Body's Defense Response
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Antioxidant
Obesity
Pomegranate peel
Oxidation
Type 2 Diabetes
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will conduct by using a prospective randomized double-blind clinical trial model.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical Blood Parameters
timeFrame: First day at the beginning of the study
measure: Biochemical Blood Parameters
timeFrame: First day at the beginning of the study
measure: Biochemical Blood Parameters
timeFrame: First day at the beginning of the study
measure: Biochemical Blood Parameters
timeFrame: First day at the beginning of the study
measure: Biochemical Blood Parameters
timeFrame: First day at the beginning of the study
measure: Anthropometric Measurements - Weight
timeFrame: First day at the beginning of the study
measure: Anthropometric Measurements - Height
timeFrame: First day at the beginning of the study
measure: Anthropometric Measurements - Body Mass Index
timeFrame: First day at the beginning of the study
measure: Anthropometric Measurements - Waist Circumference
timeFrame: First day at the beginning of the study
measure: Anthropometric Measurements - Hip Circumference
timeFrame: First day at the beginning of the study
Secondary outcomes:
measure: Biochemical Blood Parameters
timeFrame: Eight weeks after the start of the study
measure: Biochemical Blood Parameters
timeFrame: Eight weeks after the start of the study
measure: Biochemical Blood Parameters
timeFrame: Eight weeks after the start of the study
measure: Biochemical Blood Parameters
timeFrame: Eight weeks after the start of the study
measure: Biochemical Blood Parameters
timeFrame: Eight weeks after the start of the study
measure: Anthropometric Measurements - Weight
timeFrame: Eight weeks after the start of the study
measure: Anthropometric Measurements - Height
timeFrame: Eight weeks after the start of the study
measure: Anthropometric Measurements - Body Mass Index
timeFrame: Eight weeks after the start of the study
measure: Anthropometric Measurements - Waist Circumference
timeFrame: Eight weeks after the start of the study
measure: Anthropometric Measurements - Hip Circumference
timeFrame: Eight weeks after the start of the study
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Özlem ÖZPAK AKKUŞ
state: Yenişehir
Study officials:
References: