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临床试验/NCT07096505
NCT07096505已完成不适用

The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters in Obese Women: A Randomized Controlled Trial

SINEM BAYRAM1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Change in Body Weight (kg)

研究概览

简要总结

This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women.

详细描述

This randomized controlled trial investigates the effects of time-restricted eating with different timing windows on metabolic syndrome parameters. A total of 36 sedentary obese women aged between 20-49 years were randomly assigned to one of three groups: Early Time-Restricted Eating (eTRE; 08:00-16:00), Delayed Time-Restricted Eating (dTRE; 12:00-20:00), and a Control group (08:00-20:00). Participants' physical activity levels were assessed using a one-day physical activity log. Total energy expenditure was calculated, and a 25% energy restriction was applied to create individualized medical nutrition therapy. Anthropometric measurements, body composition, and biochemical parameters were collected before and after the 8-week intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •BMI > 30 kg/m²
  • •Able to follow dietary protocols
  • •No chronic disease (T1DM, T2DM, cardiovascular disease, cancer)
  • •Not on a weight loss diet in the past 6 months
  • •No psychiatric disorder
  • •Sedentary lifestyle

排除标准

  • •Menopausal women
  • •Cardiovascular disease
  • •Type 1 or Type 2 Diabetes
  • •Use of weight loss medications
  • •Pregnant or breastfeeding
  • •Shift workers

研究组 & 干预措施

Early Time-Restricted Eating with Calorie Restriction

Experimental

Participants ate all meals between 08:00 and 16:00 daily with calorie restriction diet for 8 weeks.

干预措施: Early time restricted eating with calorie restriction (Behavioral)

Delayed Time-Restricted Eating with Calorie Restriction

Experimental

Participants ate all meals between 12:00 and 20:00 daily with calorie restriction diet for 8 weeks.

干预措施: Delayed Time Restricted Eating with calorie restriction (Behavioral)

control

Active Comparator

Participants ate all meals between 08:00 and 20:00 daily with calorie restriction diet for 8 weeks.

干预措施: Control group with calorie restriction (Behavioral)

结局指标

主要结局

Change in Body Weight (kg)

时间窗: from enrollment to the end of treatment at 8 weeks

Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.

Change in Body Mass Index (BMI) (kg/m²)

时间窗: from enrollment to the end of treatment at 8 weeks

Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), will be recorded at baseline and at the end of the 8-week intervention.

Change in Waist Circumference (cm)

时间窗: from enrollment to the end of treatment at 8 weeks

Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.

Change in Body Weight (kg)

时间窗: from enrollment to the end of treatment at 8 weeks

Body weight will be measured in kilograms using standardized procedures at baseline and at the end of the 8-week intervention.

Change in Body Mass Index (BMI) (kg/m²)

时间窗: from enrollment to the end of treatment at 8 weeks

Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), will be recorded at baseline and at the end of the 8-week intervention.

Change in Waist Circumference (cm)

时间窗: from enrollment to the end of treatment at 8 weeks

Waist circumference will be measured in centimeters at baseline and at the end of the 8-week intervention using standardized anthropometric procedures.

次要结局

  • Change in HOMA-IR(From enrollment to the end of the treatment at 8 weeks)
  • Change in Fasting Glucose (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Fasting Insulin (μIU/mL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in HOMA-IR(From enrollment to the end of the treatment at 8 weeks)
  • Change in Total Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Systolic and Diastolic Blood Pressure (mmHg)(From enrollment to the end of the treatment at 8 weeks)
  • Change in LDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in HDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Triglycerides (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Fasting Glucose (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Fasting Insulin (μIU/mL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Total Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Systolic and Diastolic Blood Pressure (mmHg)(From enrollment to the end of the treatment at 8 weeks)
  • Change in LDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in HDL Cholesterol (mg/dL)(From enrollment to the end of the treatment at 8 weeks)
  • Change in Triglycerides (mg/dL)(From enrollment to the end of the treatment at 8 weeks)

研究者

发起方
SINEM BAYRAM
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SINEM BAYRAM

Assoc. Prof.

Baskent University

研究点 (1)

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