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Идёт набор NCT05750732

Weight Loss and CLOCK 3111T/C Polymorphism

— Наблюдательное Polymorphism, Restriction Fragment Length Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Weight loss diet.
Кому может быть актуально
Состояния в реестре: Polymorphism, Restriction Fragment Length, Obesity. Базовые параметры: 20 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Change in body weight [Срок оценки: Baseline to 12 weeks]
  • Change in dietary energy and nutrient intakes [Срок оценки: Baseline to 12 weeks]
  • Circadian CLOCK gene polymorphism [Срок оценки: 1 day]
Вторичные конечные точки (8)
  • Change in sleep quality [Срок оценки: Baseline to 12 weeks]
  • Change in adherence to Mediterranean diet [Срок оценки: Baseline to 12 weeks]
  • Change in adherence to DASH [Срок оценки: Baseline to 12 weeks]
  • Change in adherence to MIND [Срок оценки: Baseline to 12 weeks]
  • Change in chronotype [Срок оценки: Baseline to 12 weeks]
  • Change in eating behaviors [Срок оценки: Baseline to 12 weeks]
  • Change in night eating behaviors [Срок оценки: Baseline to 12 weeks]
  • Change in serum adiponectin and leptin level [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe University — Ankara

Идентификаторы

NCT: NCT05750732 · GO 22/1321

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗