Weight Loss and CLOCK 3111T/C Polymorphism

August 17, 2023 updated by: Hande Gül Ulusoy Gezer, Hacettepe University

Investigation of the Relationship Between Weight Loss Diet and Circadian Gene 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06050
        • Recruiting
        • Hacettepe University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Age range 20-50, BMI range of 25-40 kg/m2
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.
Control group
Age range 20-50, BMI range18.5-24.9 kg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Baseline to 12 weeks
Body weight (kg) at 12 weeks minus weight at baseline (kg)
Baseline to 12 weeks
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
Baseline to 12 weeks
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep quality
Time Frame: Baseline to 12 weeks
Using 19-item Pittsburg Sleep Quality Index (PSQI)
Baseline to 12 weeks
Change in adherence to Mediterranean diet
Time Frame: Baseline to 12 weeks
Using the 14-item Mediterranean Diet Adherence Screener (MEDAS)
Baseline to 12 weeks
Change in adherence to DASH
Time Frame: Baseline to 12 weeks
Using the 11-item Dietary Approaches to Stop Hypertension-Quality (DASH-Q)
Baseline to 12 weeks
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
Baseline to 12 weeks
Change in chronotype
Time Frame: Baseline to 12 weeks
Using the 19-item The Morningness-Eveningness Questionnaire (MEQ)
Baseline to 12 weeks
Change in eating behaviors
Time Frame: Baseline to 12 weeks
Using the 18-item The Three-Factor Eating Questionnaire (TFEQ-18)
Baseline to 12 weeks
Change in night eating behaviors
Time Frame: Baseline to 12 weeks
Using the 16-item The Night Eating Questionnaire (NEQ)
Baseline to 12 weeks
Change in serum adiponectin and leptin level
Time Frame: Baseline to 12 weeks
Using ELISA kits
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Hanife Seda Oğuz Baykal, Dr, Hacettepe University
  • Study Chair: Erdem Karabulut, Prof, Hacettepe University
  • Study Director: Neslişah Rakıcıoğlu, Prof, Hacettepe University
  • Principal Investigator: Hande Gül Ulusoy Gezer, MSc, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 22/1321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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