NCT05750732 Weight Loss and CLOCK 3111T/C Polymorphism
| NCT ID | NCT05750732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hacettepe University |
| Condition | Polymorphism, Restriction Fragment Length |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-02-20 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hanife Seda Oğuz Baykal, Dr
STUDY CHAIR
Hacettepe University
Frequently Asked Questions
Who can join the NCT05750732 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 50 Years, studying Polymorphism, Restriction Fragment Length. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05750732 currently recruiting?
Yes, NCT05750732 is actively recruiting participants. Contact the research team at handegululusoy@hacettepe.edu.tr for enrollment information.
Where is the NCT05750732 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT05750732 clinical trial?
NCT05750732 is sponsored by Hacettepe University. The principal investigator is Hanife Seda Oğuz Baykal, Dr at Hacettepe University. The trial plans to enroll 400 participants.