Weight Loss and CLOCK 3111T/C Polymorphism

Hacettepe University400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Polymorphism, Restriction Fragment Length Obesity

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in body weight

Body weight (kg) at 12 weeks minus weight at baseline (kg)

Time frame: 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

Time frame: 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

Time frame: 1 day

Secondary Outcomes

Change in sleep quality

Using 19-item Pittsburg Sleep Quality Index (PSQI)

Time frame: Baseline to 12 weeks

Change in adherence to Mediterranean diet

Using the 14-item Mediterranean Diet Adherence Screener (MEDAS)

Time frame: Baseline to 12 weeks

Change in adherence to DASH

Using the 11-item Dietary Approaches to Stop Hypertension-Quality (DASH-Q)

Time frame: Baseline to 12 weeks

Change in adherence to MIND

Using the 14-item The Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) score

Time frame: Baseline to 12 weeks

Change in chronotype

Using the 19-item The Morningness-Eveningness Questionnaire (MEQ)

Time frame: Baseline to 12 weeks

Change in eating behaviors

Using the 18-item The Three-Factor Eating Questionnaire (TFEQ-18)

Time frame: Baseline to 12 weeks

Change in night eating behaviors

Using the 16-item The Night Eating Questionnaire (NEQ)

Time frame: Baseline to 12 weeks

Change in serum adiponectin and leptin level

Using ELISA kits

Time frame: Baseline to 12 weeks

Weight Loss and CLOCK 3111T/C Polymorphism

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts