- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787314
Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial
Low Glycemic Index Diet Effects in Obesity With Insulin Resistance
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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İstanbul, Turkey, 34672
- Uskudar University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Diet
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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.
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Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
Fasting plasma glucose
Time Frame: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
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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).
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Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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.
|
Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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.
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Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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.
|
Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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.
|
Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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
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Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
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.
|
Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
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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.
|
Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarUBesYA02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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