Weight Loss and CLOCK 3111T/C Polymorphism
Study Details
Study Description
Brief Summary
The goal of this observational study is to investigate the relationship of CLOCK 3111T/C (rs1801260) gene variant with nutritional habits, nutritional status, chronotype, sleep quality, some biochemical parameters in overweight or obese individuals and to observe its effect on weight loss diet intervention. The main questions it aims to answer are:
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Is the frequency of carrying the CLOCK 3111T/C (rs1801260) gene risk allele different between individuals with normal body weight and those who are overweight or obese?
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Do those with the CLOCK 3111T/C (rs1801260) risk allele have a higher frequency of evening chronotype and a shorter sleep duration?
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Is the effect of CLOCK 3111T/C (rs1801260) gene alleles different on weight loss diet response in overweight or obese individuals? A questionnaire will be applied to the individuals in both groups (normal body weight and overweight/obese individuals) to evaluate their general characteristics, eating habits, adherence to Mediterranean diet, DASH and MIND. In addition, anthropometric measurements, 3-day food consumption record and 3-day physical activity record will be taken from individuals. CLOCK 3111T/C (rs1801260) gene variant analysis in whole blood, adiponectin and leptin hormones in serum samples will be studied. Participants those who are overweight/obese will be asked to follow a weight loss diet for 3 months.
Researchers will compare participants with normal body weight and those who are overweight or obese to see if there is a difference between the frequency of carrying the CLOCK 3111T/C (rs1801260) gene risk allele.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study group Age range 20-50, BMI range of 25-40 kg/m2 |
Behavioral: Weight loss diet
Participants in the study group will be given training on the weight loss diet, which is a routine part of their treatment.
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| Control group Age range 20-50, BMI range18.5-24.9 kg/m2 |
Outcome Measures
Primary Outcome Measures
- Change in body weight [Baseline to 12 weeks]
Body weight (kg) at 12 weeks minus weight at baseline (kg)
- Change in dietary energy and nutrient intakes [Baseline to 12 weeks]
Energy and nutrients intakes will be assessed using a dietary recall method at baseline, 4th week, 8th week and at end of the intervention
- Circadian CLOCK gene polymorphism [1 day]
Comparative analysis of the frequency distributions of genotypes and alleles of 3111T/C CLOCK gene polymorphism will be carried out both in study and control group
Secondary Outcome Measures
- Change in sleep quality [Baseline to 12 weeks]
Using 19-item Pittsburg Sleep Quality Index (PSQI)
- Change in adherence to Mediterranean diet [Baseline to 12 weeks]
Using the 14-item Mediterranean Diet Adherence Screener (MEDAS)
- Change in adherence to DASH [Baseline to 12 weeks]
Using the 11-item Dietary Approaches to Stop Hypertension-Quality (DASH-Q)
- Change in adherence to MIND [Baseline to 12 weeks]
Using the 14-item The Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) score
- Change in chronotype [Baseline to 12 weeks]
Using the 19-item The Morningness-Eveningness Questionnaire (MEQ)
- Change in eating behaviors [Baseline to 12 weeks]
Using the 18-item The Three-Factor Eating Questionnaire (TFEQ-18)
- Change in night eating behaviors [Baseline to 12 weeks]
Using the 16-item The Night Eating Questionnaire (NEQ)
- Change in serum adiponectin and leptin level [Baseline to 12 weeks]
Using ELISA kits
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be in the 20-50 age range
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BMI in the range of 25-40 kg/m2 for the study group
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BMI of 18.5-24.9 kg/m2 for the control group
Exclusion Criteria:
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Those with type 1 diabetes
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Those with Type 2 diabetes who take insulin therapy or use oral diabetes medication
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Those who use drugs for weight loss
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Those with unstable cardiovascular disease
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Those with kidney or liver failure
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Presence of diagnosed malabsorption (celiac disease, Crohn's, ulcerative colitis)
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Those who have undergone bariatric surgery
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Those who are pregnant or breastfeeding
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Menopausal women
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Those who use corticosteroids
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Those with severe endocrine disorders (hypothyroidism, hyperthyroidism, hypopituitarism)
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Those with psychiatric or neurological disease
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Weight change of >5% in the last 6 months
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Those with malignant tumors
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Those with eating disorders
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Shift workers
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Relatives
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People from different ethnic backgrounds
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hacettepe University | Ankara | Turkey | 06050 |
Sponsors and Collaborators
- Hacettepe University
Investigators
- Study Chair: Hanife Seda Oğuz Baykal, Dr, Hacettepe University
- Study Chair: Erdem Karabulut, Prof, Hacettepe University
- Study Director: Neslişah Rakıcıoğlu, Prof, Hacettepe University
- Principal Investigator: Hande Gül Ulusoy Gezer, MSc, Hacettepe University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GO 22/1321