Clinical trial NCT05787314: Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial
Official title: Low Glycemic Index Diet Effects in Obesity With Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Low Glycemic Load Diet
Obesity
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Different nutrition programs were applied to obese individuals divided into control and experimental groups. While the experimental group was given a healthy/balanced nutrition program containing carbohydrates and aimed to lose weight, a nutritional program that was balanced and aimed to lose weight but did not make any classification was applied to the control group. At the end of 8 weeks, biochemical parameters and scales were compared.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Homeostatic Model Assessment for Insulin Resistance
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Cholesterol
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Fasting plasma glucose
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Fasting insulin level
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Body weight
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Body muscle ratio
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Body muscle mass, kg
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Body mass index
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Body fat mass, kg
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
measure: Body fat ratio
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Secondary outcomes:
measure: Assessment of body image scale
timeFrame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Üsküdar University
Study officials:
References: