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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Age range 20-50, BMI range of 25-40 kg/m2 |
| |
| Control group | Age range 20-50, BMI range18.5-24.9 kg/m2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss diet | Behavioral | Participants in the study group will be given training on the weight loss diet, which is a routine part of their treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Body weight (kg) at 12 weeks minus weight at baseline (kg) | Baseline to 12 weeks |
| Change in dietary energy and nutrient intakes | Energy and nutrients intakes will be assessed using a dietary recall method at baseline, 4th week, 8th week and at end of the intervention | Baseline to 12 weeks |
| Circadian CLOCK gene polymorphism | 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep quality | Using 19-item Pittsburg Sleep Quality Index (PSQI) | Baseline to 12 weeks |
| Change in adherence to Mediterranean diet | Using the 14-item Mediterranean Diet Adherence Screener (MEDAS) |
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Inclusion Criteria:
Exclusion Criteria:
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The population of the study consists of overweight or obese individuals who applied to Hacettepe University Adult Hospital Endocrinology outpatient clinic. Individuals will be included in the study after being evaluated by the responsible physician and dietitian in Hacettepe University Adult Hospital Endocrinology outpatient clinic in terms of inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hande Gül Ulusoy Gezer, MSc | Contact | +905357314604 | handegululusoy@hacettepe.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Hanife Seda Oğuz Baykal, Dr | Hacettepe University | Study Chair |
| Erdem Karabulut, Prof | Hacettepe University | Study Chair |
| Neslişah Rakıcıoğlu, Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Recruiting | Ankara | 06050 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004038 | Diet, Reducing |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Baseline to 12 weeks |
| Change in adherence to DASH | Using the 11-item Dietary Approaches to Stop Hypertension-Quality (DASH-Q) | Baseline to 12 weeks |
| Change in adherence to MIND | Using the 14-item The Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) score | Baseline to 12 weeks |
| Change in chronotype | Using the 19-item The Morningness-Eveningness Questionnaire (MEQ) | Baseline to 12 weeks |
| Change in eating behaviors | Using the 18-item The Three-Factor Eating Questionnaire (TFEQ-18) | Baseline to 12 weeks |
| Change in night eating behaviors | Using the 16-item The Night Eating Questionnaire (NEQ) | Baseline to 12 weeks |
| Change in serum adiponectin and leptin level | Using ELISA kits | Baseline to 12 weeks |
| Hacettepe University |
| Study Director |
| Hande Gül Ulusoy Gezer, MSc | Hacettepe University | Principal Investigator |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |