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临床试验/NCT07695480
NCT07695480已完成不适用

Metabolic Responses of Diet-Exercise Combinations in Women With Obesity: A Comparative Lifestyle Intervention Study With Different Diet Types

Firat University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
Change in Body Weight

研究概览

简要总结

This study investigates the effects of different dietary strategies (ketogenic diet, intermittent fasting, and semi-vegetarian diet), alone or in combination with a structured home-based exercise program, on anthropometric, metabolic, and hormonal parameters in women with obesity. A total of 108 participants aged 19-45 years are allocated into nine groups, including control, exercise-only, diet-only, and combined intervention groups. Anthropometric outcomes (body weight, body mass index, and body fat percentage) and biochemical markers (glucose, insulin, adiponectin, IGF-1, irisin, and myostatin) are assessed at baseline and after a 6-week intervention period using bioelectrical impedance analysis and ELISA methods.

研究设计

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

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Medically and physically fit for exercise interventions.
  • No participation in any structured dietary programs within the previous 3 months.
  • Lack of orthopedic limitations that would prevent safe physical activity.

排除标准

  • Pregnancy or lactation.
  • Chronic conditions such as cancer, renal failure, or hepatic failure.
  • Diagnosed psychiatric disorders.
  • History of adverse reactions to venipuncture.
  • Inability or unwillingness to adhere to the assigned dietary and exercise intervention protocols.

结局指标

主要结局

Change in Body Weight

时间窗: Baseline and 6 weeks

Body weight will be measured in kilograms (kg) using a calibrated Bioelectrical Impedance Analysis (BIA) device (Omron Karadascan HBF-511, Japan). The outcome will evaluate the effectiveness of the 6-week lifestyle interventions on body mass reduction compared to baseline.

次要结局

  • Change in Fasting Blood Glucose(Baseline and week 6)
  • Change in Body Mass Index (BMI)(Baseline and week 6)
  • Change in Body Fat Percentage(Baseline and week 6)
  • Change in Fasting Insulin(Baseline and week 6)
  • Change in Skeletal Muscle Percentage(Baseline and week 6)
  • Change in Adiponectin Levels(Baseline and week 6)
  • Change in Insulin-Like Growth Factor 1 (IGF-1) Levels(Baseline and week 6)
  • Change in Irisin Levels(Baseline and week 6)
  • Change in Myostatin Levels(Baseline and week 6)

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Subaşı

PhD Student

Firat University

研究点 (1)

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