Back to resultsEffect of Low Glycemic Index Diet on COVID-19 Phobia, Biochemical Parameters and Body Image in Obesity With Insulin Resistance
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low Glycemic Index Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Low Glycemic Load Diet, Obesity
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
Sites / Locations
- Üsküdar University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Control Diet
Arm Description
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. 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)
Outcomes
Primary Outcome Measures
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).
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.
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).
Fasting insulin level
Fasting insulin is between 18-48 pmol/L.
Body weight
Body weight was measured in kilograms.
Body muscle ratio
Body muscle ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Body muscle mass, kg
Body muscle mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Body mass index
Body mass index (BMI)=weight/(height)^2
Body fat mass, kg
Body fat mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Body fat ratio
Body fat ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Secondary Outcome Measures
Assessment of the coronavirus disease phobia scale
The Coronavirus disease (COVID-19) phobia (C19P-S) is a 5-point Likert-type self-assessment scale developed to measure phobia against the coronavirus. Scale items; It is evaluated between 1 "Strongly Disagree" and 5 "Strongly Agree". Items 1, 5, 9, 13, 17, and 20 Psychological Sub-Dimension; items 2, 6, 10, 14 and 18 Somatic Sub-Dimension; items 3, 7, 11, 15 and 19 Social Sub-Dimension; items 4, 8, 12, and 16 measure the Economic Sub-Dimension. While the sub-dimension scores are obtained by the sum of the answers given to the items belonging to that sub-dimension; The total C19P-S score is obtained by summing the sub-dimension scores and ranges from 20 to 100 points. Higher scores indicate height in lower dimensions and general C19P-S.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05787314
Brief Title
Effect of Low Glycemic Index Diet on COVID-19 Phobia, Biochemical Parameters and Body Image in Obesity With Insulin Resistance
Official Title
Low Glycemic Index Diet Effects in Obesity With Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine how a low glycemic index diet (LGID) changes biochemical parameters, body measurements, coronavirus disease (COVID-19) Phobia (C19P) 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, C19P 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 C19P, 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 C19P compared to CD.
Determination of the effect of LGID on body image perception status compared to CD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Low Glycemic Load Diet, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Masking Description
prospective, two-arm randomized-controlled trial, Researchers who have no knowledge about group allocation and study's objectives, will collected the post-intervention data.
Allocation
N/A
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Diet
Arm Type
Experimental
Arm Description
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.
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)
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Diet
Other Intervention Name(s)
LGID Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Homeostatic Model Assessment for Insulin Resistance
Description
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).
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Cholesterol
Description
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.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Fasting plasma glucose
Description
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).
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Fasting insulin level
Description
Fasting insulin is between 18-48 pmol/L.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Body weight
Description
Body weight was measured in kilograms.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Body muscle ratio
Description
Body muscle ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Body muscle mass, kg
Description
Body muscle mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Body mass index
Description
Body mass index (BMI)=weight/(height)^2
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Body fat mass, kg
Description
Body fat mass as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Body fat ratio
Description
Body fat ratio as assessed by bioelectrical impedance analysis -- whole body composition was evaluated.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Secondary Outcome Measure Information:
Title
Assessment of the coronavirus disease phobia scale
Description
The Coronavirus disease (COVID-19) phobia (C19P-S) is a 5-point Likert-type self-assessment scale developed to measure phobia against the coronavirus. Scale items; It is evaluated between 1 "Strongly Disagree" and 5 "Strongly Agree". Items 1, 5, 9, 13, 17, and 20 Psychological Sub-Dimension; items 2, 6, 10, 14 and 18 Somatic Sub-Dimension; items 3, 7, 11, 15 and 19 Social Sub-Dimension; items 4, 8, 12, and 16 measure the Economic Sub-Dimension. While the sub-dimension scores are obtained by the sum of the answers given to the items belonging to that sub-dimension; The total C19P-S score is obtained by summing the sub-dimension scores and ranges from 20 to 100 points. Higher scores indicate height in lower dimensions and general C19P-S.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
Title
Assessment of body image scale
Description
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.
Time Frame
Changes within and between groups are evaluated on the start and last day of the intervention (day 60).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Üsküdar University
City
İstanbul
ZIP/Postal Code
34672
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effect of Low Glycemic Index Diet on COVID-19 Phobia, Biochemical Parameters and Body Image in Obesity With Insulin Resistance
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