Weight Loss and CLOCK 3111T/C Polymorphism

Study Overview
=================
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: 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? Do those with the CLOCK 3111T/C (rs1801260) risk allele have a higher frequency of evening chronotype and a shorter sleep duration? 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.

Official Title
-----------------
Investigation of the Relationship Between Weight Loss Diet and Circadian Gene CLOCK 3111T/C Polymorphism

Conditions
-----------------
Polymorphism, Restriction Fragment Length, Obesity

Intervention / Treatment
-----------------
* Behavioral: Weight loss diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be in the 20-50 age range BMI in the range of 25-40 kg/m2 for the study group BMI of 18.5-24.9 kg/m2 for the control group Exclusion Criteria: Those with type 1 diabetes Those with Type 2 diabetes who take insulin therapy or use oral diabetes medication Those who use drugs for weight loss Those with unstable cardiovascular disease Those with kidney or liver failure Presence of diagnosed malabsorption (celiac disease, Crohn's, ulcerative colitis) Those who have undergone bariatric surgery Those who are pregnant or breastfeeding Menopausal women Those who use corticosteroids Those with severe endocrine disorders (hypothyroidism, hyperthyroidism, hypopituitarism) Those with psychiatric or neurological disease Weight change of >5% in the last 6 months Those with malignant tumors Those with eating disorders Shift workers Relatives People from different ethnic backgrounds

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Age range 20-50, BMI range of 25-40 kg/m2 | Behavioral: Weight loss diet<br>* Participants in the study group will be given training on the weight loss diet, which is a routine part of their treatment.<br>|
| Control group<br>Age range 20-50, BMI range18.5-24.9 kg/m2 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, circadian rhythm, polymorphism, CLOCK gene, weight loss diet