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NCT Number: NCT05787314

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Üsküdar University

Istanbul, 34672, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic index diet

Behavioral
  • 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.

Other names: LGID Group

Primary outcomes

  1. Homeostatic Model Assessment for Insulin Resistance

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

    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).

  2. Cholesterol

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

    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.

  3. Fasting plasma glucose

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

    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).

  4. Fasting insulin level

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

    Fasting insulin is between 18-48 pmol/L.

  5. Body weight

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

    Body weight was measured in kilograms.

  6. Body muscle ratio

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

    Body muscle ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.

  7. Body muscle mass, kg

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

    Body muscle mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.

  8. Body mass index

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

    Body mass index (BMI)=weight/(height)^2

  9. Body fat mass, kg

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

    Body fat mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.

  10. Body fat ratio

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

    Body fat ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.

Secondary outcomes

  1. Assessment of body image scale

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

    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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Low Glycemic Index Diet Effects in Obesity With Insulin Resistance

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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