NCT05787314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

March 12, 2023

Last Update Submit

October 31, 2023

Conditions

Obesity

Keywords

Low Glycemic Load DietObesity

Outcome Measures

Primary Outcomes (10)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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 Outcomes (1)

  • Assessment of body image scale

    Changes within and between groups are evaluated on the start and last day of the intervention (day 120).

Study Arms (1)

Control Diet

EXPERIMENTAL

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)

Behavioral: Low Glycemic Index Diet

Interventions

Low Glycemic Index DietBEHAVIORAL

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.

Also known as: LGID Group
Control Diet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar University

Istanbul, 34672, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
prospective, two-arm randomized-controlled trial, Researchers who have no knowledge about group allocation and study's objectives, will collected the post-intervention data.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 28, 2023

Study Start

February 20, 2022

Primary Completion

May 24, 2022

Study Completion

August 2, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

TU(1)