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

NCT ID: NCT05787314

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-20

Study Completion Date

2023-08-02

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

prospective, two-arm randomized-controlled trial, Researchers who have no knowledge about group allocation and study's objectives, will collected the post-intervention data.

Study Groups

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Control 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)

Group Type EXPERIMENTAL

Low Glycemic Index Diet

Intervention Type BEHAVIORAL

1. 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.
2. 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.

Interventions

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Low Glycemic Index Diet

1. 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.
2. 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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LGID Group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Mesut Karahan

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Üsküdar University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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UskudarUBesYA02

Identifier Type: -

Identifier Source: org_study_id

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