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NCT Number: NCT05750732

Weight Loss and CLOCK 3111T/C Polymorphism

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.

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Key information

Conditions

Polymorphism, Restriction Fragment Length Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06050, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hande Gül Ulusoy Gezer, MSc

CONTACT

[email protected]

+905357314604

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in body weight

    Time frame: Baseline to 12 weeks

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

  2. Change in dietary energy and nutrient intakes

    Time frame: Baseline 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

  3. Circadian CLOCK gene polymorphism

    Time frame: 1 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

Secondary outcomes

  1. Change in sleep quality

    Time frame: Baseline to 12 weeks

    Using 19-item Pittsburg Sleep Quality Index (PSQI)

  2. Change in adherence to Mediterranean diet

    Time frame: Baseline to 12 weeks

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

  3. Change in adherence to DASH

    Time frame: Baseline to 12 weeks

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

  4. Change in adherence to MIND

    Time frame: Baseline to 12 weeks

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

  5. Change in chronotype

    Time frame: Baseline to 12 weeks

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

  6. Change in eating behaviors

    Time frame: Baseline to 12 weeks

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

  7. Change in night eating behaviors

    Time frame: Baseline to 12 weeks

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

  8. Change in serum adiponectin and leptin level

    Time frame: Baseline to 12 weeks

    Using ELISA kits

Study contacts

Contact information is provided by the study sponsor or research team.

Hande Gül Ulusoy Gezer, MSc

CONTACT

[email protected]

+905357314604

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 2, 2023
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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