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临床试验/NCT04143971
NCT04143971已完成不适用

Effects of Intermittent Fasting Compared to Continuous Calorie Restriction on Weight Loss & Plasma Lipids in Hypertriglyceridemic Overweight or Obese Subjects

Shahid Beheshti University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Weight loss

研究概览

简要总结

some studies have shown similar effects of intermittent fasting and continuous caloric restriction on body weight and plasma lipid profile, but there is still a wide controversy. Therefore,due to limited human studies and the lack of a study on hypertriglyceridemic patients, the present study aimed to determine the effects of using low-calorie diets in comparison with continuous caloric restriction on weight loss and plasma lipid profile in obese or overweight hypertriglyceridemic patients.

详细描述

a randomized clinical trial will be conducted in National Nutrition and Food Technology Research Institute, Tehran, Iran. after the review of inclusion and exclusion criteria, a written consent form will be completed. the participants will be 90 hypertriglyceridemic patients aged between 18-60. half of the participants will be under intermittent low-calorie diet which they will have 3 alternate days in the week eating only 30% of their total energy requirement and on the other days of the week they receive a total calorie of 100% of their energy requirement , therefore there will be a total of -210% TEE reduction in their received energy in the week. the other group will be under continuous calorie restriction meaning on all the days of the week they will be eating 70% of their total energy requirement resulting in a total of -210% TEE reduction in their received energy in the week. both groups will receive 3 consultation sessions with a nutritionist, also to prevent any deficiency, multi-vitamin-mineral supplements will be given to both groups participants.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • hypertriglyceridemic : TG>150 mg/dL
  • BMI>24.9
  • age 18-60
  • non-smoker
  • haven't been under any diet at least 3 months before participating in the study
  • not starting any new exercise program or changing the previous exercise while in the study

排除标准

  • chronic kidney disease stage 3-5
  • consuming Insulin or Insulin-inducing drugs.
  • consuming triglycerides lowering drugs or Omega 3
  • a history of cholecystitis
  • Heart arrhythmia

结局指标

主要结局

Weight loss

时间窗: at 8 weeks

Mean weight change of participants (kg) after 8 weeks of diets

次要结局

  • Plasma Triglycerides(at 8 weeks)

研究者

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

Javad Nasrollahzadeh

Director

Shahid Beheshti University

研究点 (2)

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