Investigation of the Relationship Between Weight Loss Diet and Circadian Gene CLOCK 3111T/C Polymorphism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in body weight
时间窗: Baseline to 12 weeks
Body weight (kg) at 12 weeks minus weight at baseline (kg)
Change in dietary energy and nutrient intakes
时间窗: 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
Circadian CLOCK gene polymorphism
时间窗: 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
次要结局
- Change in adherence to MIND(Baseline to 12 weeks)
- Change in sleep quality(Baseline to 12 weeks)
- Change in adherence to DASH(Baseline to 12 weeks)
- Change in eating behaviors(Baseline to 12 weeks)
- Change in adherence to Mediterranean diet(Baseline to 12 weeks)
- Change in chronotype(Baseline to 12 weeks)
- Change in serum adiponectin and leptin level(Baseline to 12 weeks)
- Change in night eating behaviors(Baseline to 12 weeks)
研究者
Hande Gül Ulusoy Gezer
Research Assistant
Hacettepe University