Low Glycemic Index Diet Effects in Obesity With Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
To examine how a low glycemic index diet (LGID) changes biochemical parameters, body measurements, and body image perception in obese individuals with insulin resistance. Obesity groups with insulin resistance who received a control diet (CD) and a LGID will be compared with each other in terms of biochemical parameters, body image perception and body measurements. In addition, each group will be compared with the start and end measurements over the same values.
详细描述
The main purpose of this study is to determine the effect of LGID on body image perception, biochemical parameters and body measurements in obese individuals with insulin resistance.
Sub-objectives of the study;
Determination of the effect of LGID on fasting blood glucose, fasting insulin level and HOMA-IR levels compared to CD.
Determination of the effect of LGID on body weight, fat mass, muscle mass, body muscle ratio and body mass index (BMI) compared to CD.
Determination of the effect of LGID on body image perception status compared to CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
prospective, two-arm randomized-controlled trial, Researchers who have no knowledge about group allocation and study's objectives, will collected the post-intervention data.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm)
- •Can provide informed consent
- •Can be contacted by telephone
- •Waist circumference > 90 cm for men and > 80 cm for women
排除标准
- •Pregnancy or lactation
- •Active or suspected chronic infection
- •Treatment affecting insulin sensitivity
- •A secondary disease state (Cardiovascular disease, cancer, psychiatric, etc.)
- •Any weight loss operation (gastric bypass, gastric balloon, etc.)
- •A special nutritional program (cancer, kidney disease, etc.)
- •Using any food supplement or medication known to affect whole body metabolism
结局指标
主要结局
Body weight
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Body weight was measured in kilograms.
Body muscle mass, kg
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Body muscle mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Homeostatic Model Assessment for Insulin Resistance
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index was obtained by the following formula: fasting glucose (mg/dl/18) x fasting insulin (U/mL)/22.5. A HOMA-IR index \>2.5 is in favor of Insulin Resistance (IR).
Cholesterol
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Blood samples were collected after an overnight fast by using 10 mL plain tubes. Lipid profile was measured by using Cholesterol Kits and total cholesterol levels were measured using the sum of the LDL and HDL plus one-fifth of triglyceride levels.
Body mass index
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Body mass index (BMI)=weight/(height)\^2
Fasting plasma glucose
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Fasting plasma glucose (FPG) levels were determined by taking a blood sample from participants who have fasted for at least 8 hours, Fasting glucose is between 75-95 mg/dL (4.2-5.3 mmol/L).
Fasting insulin level
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Fasting insulin is between 18-48 pmol/L.
Body muscle ratio
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Body muscle ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Body fat mass, kg
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Body fat mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Body fat ratio
时间窗: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Body fat ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
次要结局
- Assessment of body image scale(Changes within and between groups are evaluated on the start and last day of the intervention (day 120).)
研究者
Mesut Karahan
Assoc. Prof.
Uskudar University