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

Obesity Clinical Trial

Official title:

Low Glycemic Index Diet Effects in Obesity With Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787314
• Other study ID #: UskudarUBesYA02
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: October 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2, 2023
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Behavioral:
• Low Glycemic Index Diet
Participants who came to the hospital for control and were interested in the study contacted the study researchers and eligibility was determined through face-to-face interviews. Potential participants were invited to a screening visit to verify eligibility. The LGID program was initiated as an outpatient treatment in patients who applied to a dietitian. 3) Medium and high GI carbohydrates (GI > 55) were excluded from the diet and only low GI (GI < 50) foodstuffs were allowed. 4) A list of low glycemic index foods were given to the patients. In addition, a list of foods to avoid (medium and high glycemic index) is provided.

Locations

Country	Name	City	State
Turkey	Üsküdar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostatic Model Assessment for Insulin Resistance	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).	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Cholesterol	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.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Fasting plasma glucose	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).	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Fasting insulin level	Fasting insulin is between 18-48 pmol/L.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Body weight	Body weight was measured in kilograms.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Body muscle ratio	Body muscle ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Body muscle mass, kg	Body muscle mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Body mass index	Body mass index (BMI)=weight/(height)^2	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Body fat mass, kg	Body fat mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Primary	Body fat ratio	Body fat ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Secondary	Assessment of body image scale	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.	Changes within and between groups are evaluated on the start and last day of the intervention (day 120).