Weight Loss and CLOCK 3111T/C Polymorphism

NCT05750732 | Recruiting

• 1 other identifier: GO 22/1321
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Polymorphism, Restriction Fragment Length; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change in sleep quality

  Baseline to 12 weeks

• Change in adherence to Mediterranean diet

  Baseline to 12 weeks

• Change in adherence to DASH

  Baseline to 12 weeks

• Change in adherence to MIND

  Baseline to 12 weeks

• Change in chronotype

  Baseline to 12 weeks

Study Arms (2)

Study group

Age range 20-50, BMI range of 25-40 kg/m2

Behavioral: Weight loss diet

Control group

Age range 20-50, BMI range18.5-24.9 kg/m2

Interventions

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.

Study group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The population of the study consists of overweight or obese individuals who applied to Hacettepe University Adult Hospital Endocrinology outpatient clinic. Individuals will be included in the study after being evaluated by the responsible physician and dietitian in Hacettepe University Adult Hospital Endocrinology outpatient clinic in terms of inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hanife Seda Oğuz Baykal, Dr

  Hacettepe University

  STUDY CHAIR

• Erdem Karabulut, Prof

  Hacettepe University

  STUDY CHAIR

• Neslişah Rakıcıoğlu, Prof

  Hacettepe University

  STUDY DIRECTOR

• Hande Gül Ulusoy Gezer, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hande Gül Ulusoy Gezer, MSc

CONTACT

+905357314604; handegululusoy@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: February 20, 2023
• Primary Completion: June 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2024-10

Locations

TU (1)