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
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Biochemical Blood Parameters
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants will not know which type of bread to eat.
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
No intervention - Control Group
Individuals with type 2 diabetes will not eat pomegranate crust bread
People with type 2 diabetes who eat bread with pomegranate crust - Experimental Group
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.
干预措施: Pomegranate Peel (Dietary Supplement)
结局指标
主要结局
Biochemical Blood Parameters
时间窗: First day at the beginning of the study
Examination of between group differences regarding lipid profile
Anthropometric Measurements - Weight
时间窗: First day at the beginning of the study
Examination of between group differences regarding weight in kilogram
Anthropometric Measurements - Hip Circumference
时间窗: First day at the beginning of the study
Examination of between group differences regarding hip circumference in centimeters
Anthropometric Measurements - Height
时间窗: First day at the beginning of the study
Examination of between group differences regarding height in meter
Anthropometric Measurements - Body Mass Index
时间窗: First 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 Circumference
时间窗: First day at the beginning of the study
Examination of between group differences regarding waist circumference in centimeters
次要结局
- Biochemical Blood Parameters(Eight weeks after the start of the study)
- Anthropometric Measurements - Height(Eight weeks after the start of the study)
- Anthropometric Measurements - Weight(Eight weeks after the start of the study)
- Anthropometric Measurements - Body Mass Index(Eight weeks after the start of the study)
- Anthropometric Measurements - Waist Circumference(Eight weeks after the start of the study)
- Anthropometric Measurements - Hip Circumference(Eight weeks after the start of the study)
研究者
Özlem ÖZPAK AKKUŞ
Principal Investigator
Toros University