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Weight Loss and CLOCK 3111T/C Polymorphism

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05750732
Enrollment
400
Registered
2023-03-02
Start date
2023-02-20
Completion date
2026-02-01
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Polymorphism, Restriction Fragment Length

Keywords

obesity, circadian rhythm, polymorphism, CLOCK gene, weight loss diet

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.

Interventions

Participants in the study group will be given training on the weight loss diet, which is a routine part of their treatment.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in body weightBaseline to 12 weeksBody weight (kg) at 12 weeks minus weight at baseline (kg)
Change in dietary energy and nutrient intakesBaseline to 12 weeksEnergy 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 dayComparative 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

MeasureTime frameDescription
Change in adherence to MINDBaseline to 12 weeksUsing the 14-item The Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) score
Change in chronotypeBaseline to 12 weeksUsing the 19-item The Morningness-Eveningness Questionnaire (MEQ)
Change in sleep qualityBaseline to 12 weeksUsing 19-item Pittsburg Sleep Quality Index (PSQI)
Change in night eating behaviorsBaseline to 12 weeksUsing the 16-item The Night Eating Questionnaire (NEQ)
Change in serum adiponectin and leptin levelBaseline to 12 weeksUsing ELISA kits
Change in eating behaviorsBaseline to 12 weeksUsing the 18-item The Three-Factor Eating Questionnaire (TFEQ-18)
Change in adherence to Mediterranean dietBaseline to 12 weeksUsing the 14-item Mediterranean Diet Adherence Screener (MEDAS)
Change in adherence to DASHBaseline to 12 weeksUsing the 11-item Dietary Approaches to Stop Hypertension-Quality (DASH-Q)

Countries

Turkey (Türkiye)

Contacts

Primary ContactHande Gül Ulusoy Gezer, MSc
handegululusoy@hacettepe.edu.tr+905357314604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026