Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial

Uskudar University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Low Glycemic Index Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05787314

UskudarUBesYA02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

124 participants in 1 patient group

Control Diet

Experimental group

Description:

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)

Treatment:

Behavioral: Low Glycemic Index Diet