The Influence of Daily Honey Consumption on Insulin Resistance in Obese Women With Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dietary intake (A daily treatment consumption)
研究概览
简要总结
The main objective of the study is to evaluate the effects of daily honey consumption on insulin resistance as a preventive measure against diabetes. in women with insulin resistance.
详细描述
The prevalence rates of insulin resistance (IR) and its health consequences are increasing worldwide. The reputation of honey as a healthy alternative for sugar is largely accepted. Honey contains several bioactive constituents; however, its effect on IR measures and glycemic control is yet to be assessed. We aim to evaluate the effect of daily consumption of honey on IR and inflammatory status measures in obese women with insulin resistance in a free-living controlled intervention study. Sixty obese adult females with insulin resistance will be recruited from the community of the University of Jordan and from patients at the Endocrine unit at the University of Jordan Hospital. Participants will be randomly assigned into one of two treatment groups, honey group or jell-O group. Participants will consume a daily dose of 0.5 mg per kg of body weight of the prescribed treatment for 6 months. The effects of daily consumption of honey on IR, serum concentration of several inflammatory biomarkers, and body fatness will be evaluated. The results of this study would reveal the antidiabetic effect of the bioactive compounds in honey in insulin-resistant obese women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •19-45 years
- •Obese (BMI >= 30 kg/m^2)
- •Premenopausal
排除标准
- •Individual who use any drug or supplements known to affect lipid, glucose for at least the last three months.
- •Individual who previous insulin treatment
- •Individual who have diabetes, kidney, liver, or hormonal diseases
- •Individual who have significant weight changes > 5% during the past 6 months
- •Women who are postmenopausal
研究组 & 干预措施
Honey
Treatment with honey will extend for four months and the actual treatment phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from honey consumption.
During the six months intervention, a daily dose of 0.5 g/kg body weight of honey will be consumed by each participant. Participants will be provided with Mixed flora honey that will be obtained from local producers. The daily dose of treatments will be divided into two doses to simulate a natural pattern of consumption.
All participants will be required to limit the consumption of caffeinated beverages to two beverages a day during the study periods.
A nutritionist will calculate the energy requirement and provide dietary instructions and a nutritionally adequate, hypocaloric, balanced sample diet plan with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein will be individualized for each participant monthly.
干预措施: Honey (Dietary Supplement)
Other carbohydrate alternatives
Treatment with simple sugar alternatives (other carbohydrates, such as jell-o) will extend for four months and the actual treatment phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from honey consumption, and during the study periods.
A daily dose of 0.5 g/kg body weight of jell-O will be consumed by each participant and will be divided into two doses to simulate a natural pattern of consumption. Jell-O was selected as a source of sucrose with negligible phenolic capacity, which will serve as a control.
All participants will be required to limit the consumption of caffeinated beverages to two beverages a day during the study periods.
A nutritionist will calculate the energy requirement and provide dietary instructions and a nutritionally adequate, hypocaloric, balanced sample diet plan with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein will be individualized for each participant monthly.
干预措施: Other carbohydrate alternatives such as jell-o (Dietary Supplement)
结局指标
主要结局
Dietary intake (A daily treatment consumption)
时间窗: Every day of the treatment period (4 months)
A daily treatment consumption checklist will be filled by each participant using the mobile App.
Dietary intake
时间窗: Change from Baseline at 4 months
Participants will provide a 3-day food record. Dietary data will be analyzed for energy, macro- and micro-nutrients composition using the food processor SQL version 10.3.0 program (ESHA Research, Salem, Oregon).
Biochemical measurements (OGTT)
时间窗: Change from Baseline at 4 months
OGTT (75 g of glucose) will be executed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws. During OGTT venous blood samples will be obtained at 0, 30, 60, 90 and 120 min for the determination of glucose and insulin.
Biochemical measurements (OHTT)
时间窗: Change from Baseline at 4 months
OHTT (75 g of honey) will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws. During OHTT venous blood samples will be obtained at 0, 30, 60, 90 and 120 min for the determination of glucose and insulin.
Anthropometric measurements (Waist circumference)
时间窗: Change from Baseline at 4 months
The average waist circumference will be calculated from 2 consecutive measurements at the midway between the lowest rib and iliac crest.
Anthropometric measurements (A body composition assessment)
时间窗: Change from Baseline at 4 months
A body composition assessment will be performed using InBody120 analyzer (InBody, CO.). Participants will be asked to remove any metal items and heavy clothes before scanning, and will be scanned barefoot and wearing light clothes. Participant positioning will be conducted in accordance with the operator's manual.A trained operator will assess body composition according to the manufacturer's instructions.
Biochemical measurements (Insulin level)
时间窗: Change from Baseline at 4 months
Insulin level test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Biochemical measurements (HbA1C)
时间窗: Change from Baseline at 4 months
HbA1C test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Biochemical measurements (C-reactive protein)
时间窗: Change from Baseline at 4 months
C-reactive protein test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Biochemical measurements (High density lipoprotein- cholesterol (HDL-C))
时间窗: Change from Baseline at 4 months
High density lipoprotein- cholesterol (HDL-C) test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Anthropometric measurements (Height)
时间窗: On the first day
Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.
Biochemical measurements (Triglyceride)
时间窗: Change from Baseline at 4 months
Triglyceride test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Anthropometric measurements (Weight)
时间窗: Change from Baseline at 4 months
Weight will be measured using a calibrated digital scale to the nearest 0.1 kg. All participants will be measured in light clothing and without any heavy articles or footwear.
Biochemical measurements (Adiponectin)
时间窗: Change from Baseline at 4 months
Adiponectin test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Biochemical measurements (Glucose level)
时间窗: Change from Baseline at 4 months
Glucose level test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Biochemical measurements (Total cholesterol)
时间窗: Change from Baseline at 4 months
Total cholesterol test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
次要结局
未报告次要终点
研究者
Shatha Hammad, Assistant Professor
Assistant Professor
University of Jordan