Weight Loss and CLOCK 3111T/C Polymorphism

NCT ID: NCT05750732

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Polymorphism, Restriction Fragment Length Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study group

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

Weight loss diet

Intervention Type BEHAVIORAL

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

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Hande Gül Ulusoy Gezer

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanife Seda Oğuz Baykal, Dr

Role: STUDY_CHAIR

Hacettepe University

Erdem Karabulut, Prof

Role: STUDY_CHAIR

Hacettepe University

Neslişah Rakıcıoğlu, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Hande Gül Ulusoy Gezer, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hande Gül Ulusoy Gezer, MSc

Role: CONTACT

+905357314604

Facility Contacts

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Hande Gül Ulusoy Gezer, MSc

Role: primary

+905357314604

Other Identifiers

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GO 22/1321

Identifier Type: -

Identifier Source: org_study_id

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