Weight Loss and CLOCK 3111T/C Polymorphism

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750732
• Other study ID #: GO 22/1321
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: August 2023
• Source: Hacettepe University
• Contact: Hande Gül Ulusoy Gezer, MSc
• Phone: +905357314604
• Email: handegululusoy[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Polymorphism, Restriction Fragment Length
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Body weight (kg) at 12 weeks minus weight at baseline (kg)	Baseline to 12 weeks
Primary	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
Primary	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	Change in sleep quality	Using 19-item Pittsburg Sleep Quality Index (PSQI)	Baseline to 12 weeks
Secondary	Change in adherence to Mediterranean diet	Using the 14-item Mediterranean Diet Adherence Screener (MEDAS)	Baseline to 12 weeks
Secondary	Change in adherence to DASH	Using the 11-item Dietary Approaches to Stop Hypertension-Quality (DASH-Q)	Baseline to 12 weeks
Secondary	Change in adherence to MIND	Using the 14-item The Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) score	Baseline to 12 weeks
Secondary	Change in chronotype	Using the 19-item The Morningness-Eveningness Questionnaire (MEQ)	Baseline to 12 weeks
Secondary	Change in eating behaviors	Using the 18-item The Three-Factor Eating Questionnaire (TFEQ-18)	Baseline to 12 weeks
Secondary	Change in night eating behaviors	Using the 16-item The Night Eating Questionnaire (NEQ)	Baseline to 12 weeks
Secondary	Change in serum adiponectin and leptin level	Using ELISA kits	Baseline to 12 weeks