ObesityNCT05787314
Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial
A study testing Low Glycemic Index Diet in people with Obesity, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Low Glycemic Index Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2022to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Glycemic Index Diet Effects in Obesity With Insulin Resistance
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Low Glycemic Index Diet
- Keywords
- Low Glycemic Load Diet, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic Index DietBehavioural
Also called LGID Group
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Low Glycemic Index Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Changes within and between groups are evaluated on the start and last day of the intervention (day 120).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start20 Feb 2022
- Primary completion24 May 2022
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Karahan, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787314
- Sponsor's protocol ID
- UskudarUBesYA02
- Status last verified
- Oct 2023
- First submitted
- 12 Mar 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Glycemic Index Diet Effects in Obesity With Insulin Resistance
- ClinicalTrials.gov ID
- NCT05787314
- Acronym / sponsor ID
- UskudarUBesYA02
- Conditions
- Obesity
- Keywords
- Low Glycemic Load Diet, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Diet | Experimental | Behavioral: Low Glycemic Index Diet1. 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glycemic Index DietAlso: LGID Group1. 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. | Behavioural | Control Diet |
Primary outcome
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).
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.
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).
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.
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.
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.
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.
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
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.
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Index Diet in people with Obesity, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.