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临床试验/NCT03652532
NCT03652532已完成不适用

Effects of Alternate Day Fasting and Exercise on Body Weight, Visceral Fat, and Metabolic Parameters in Overweight or Obese Adults: A Randomized Controlled Trial

Gangnam Severance Hospital0 个研究点目标入组 100 人开始时间: 2014年4月10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
入组人数
100
主要终点
Change in body weight

研究概览

简要总结

Alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. However, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in Korea. The purpose of this randomized clinical trial is to examine the effects of alternate day fasting and exercise on weight reduction, visceral fat, and metabolic parameters in overweight or obese adults.

研究设计

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

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-65 years
  • Body mass index (BMI) more than 23.0 kg/m² (overweight or obese for Asian populations, according to the World Health Organization)

排除标准

  • Participants with weight gain more than 5kg in the last 3 months
  • Participants with history of bariatric surgery
  • Participants with secondary obesity, such as hypothyroidism
  • Participants with uncontrolled hypertension or type 1 diabetes
  • Participants who are taking anti-diabetic medications due to type 2 diabetes
  • Participants with hepatic disease (AST or ALT ≥200 mg/dL)
  • Participants with renal disease (serum creatinine ≥2.0 mg/dL)
  • Participants with pancreatitis or related disorders
  • Participants with acute infectious diseases (i.e., pneumonia, acute enteritis, or urinary infection)
  • Participants with chronic inflammatory diseases (i.e., rheumatoid arthritis, or lupus)
  • Participants with overeating behavior
  • Participants with history of cardiovascular diseases
  • Participants with history of cancer
  • Participants who are taking anti-obesity, anti-diabetic, diuretic, central-nervous system, antidepressant, antipsychotic, or steroid medications
  • Pregnant or lactating women
  • Participants who intake more than 30 g of alcohol daily
  • Night-time or shift-work workers
  • Participants with chronic malabsorption syndrome or cholestasis
  • Participants with other medical conditions that would preclude subjects from participating in exercise and physical test

研究组 & 干预措施

Alternate Day Fasting and Exercise

Experimental

干预措施: Alternate Day Fasting (Behavioral)

Alternate Day Fasting and Exercise

Experimental

干预措施: Exercise (Behavioral)

Alternate Day Fasting

Experimental

干预措施: Alternate Day Fasting (Behavioral)

Exercise

Experimental

干预措施: Exercise (Behavioral)

Control

No Intervention

regular eating and exercise habits for 8 weeks

结局指标

主要结局

Change in body weight

时间窗: baseline, 8 weeks

body weight (kg)

次要结局

  • Change in visceral fat(baseline, 8 weeks)
  • Change in fasting glucose(baseline, 8 weeks)
  • Change in insulin(baseline, 8 weeks)
  • Change in triglyceride(baseline, 8 weeks)
  • Change in high-density lipoprotein cholesterol (HDL-cholesterol)(baseline, 8 weeks)
  • Change in low-density lipoprotein cholesterol (LDL-cholesterol)(baseline, 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji-Won Lee

Associate Professor

Gangnam Severance Hospital

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