Clinical trial

Weight Loss and CLOCK 3111T/C Polymorphism

Recruiting now · Not applicable · 1 countries · Registry ID NCT05750732

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 50 Years

SexAll

Healthy volunteersAccepted

ConditionPolymorphism, Restriction Fragment Length, Obesity

Full registry 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

Treatments and study arms

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.

Primary outcomes

Change in body weightBaseline to 12 weeks

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

Change in dietary energy and nutrient intakesBaseline 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 polymorphism1 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

Study locations

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Hacettepe University🌐 Ankara, Turkey (Türkiye)

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Hande Gül Ulusoy Gezer, MScContact

Email · Call +905357314604