Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial
- Conditions
- Obesity
- Interventions
- Behavioral: Low Glycemic Index Diet
- Registration Number
- NCT05787314
- Lead Sponsor
- Uskudar University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Control Diet Low Glycemic Index Diet 1. For the Control Diet, a medical nutrition therapy with calorie and fat content was prepared to ensure weight loss of individuals without considering the glycemic index. 2. The aim of this diet is to achieve weight loss, but not to focus on the content of carbohydrates. 3) In the macro element distribution of the CD, 50-55% carbohydrates, 10-15% protein and 20-25% fat distribution Other name (CD Group)
- Primary Outcome Measures
Name Time Method Body weight 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 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.
Body fat ratio 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.
Cholesterol 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 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
Homeostatic Model Assessment for Insulin Resistance 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).Fasting plasma glucose 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Assessment of body image scale Changes within and between groups are evaluated on the start and last day of the intervention (day 120). The body image scale (BIS) includes 10 items, and was developed to briefly and comprehensively assess the affective (e.g., feeling self-conscious), behavioral (e.g., difficulty in looking at the naked body), and cognitive (e.g., satisfaction with appearance) aspects of body image in patients. It is a 4-point scale (0 = not at all and 3 = very much), and the final score is the sum of scores for 10 items, ranging from 0 to 30, with a lower score representing a better body image.
Trial Locations
- Locations (1)
Üsküdar University
🇹🇷İstanbul, Turkey