NCT03120260已完成不适用
Comparing the Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program: A 12 Week Randomized Controlled Trial
Novindiet Clinic2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2017年6月15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
- 50
- 试验地点
- 2
- 主要终点
- weight loss
研究概览
简要总结
The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be female
- •Must have < 7 hour sleep per night
- •Must be 18-45 years of age.
- •Must have Body mass index (BMI) between 27-35 kg/ m².
- •Must be able to have moderate exercise.
- •Must be interested to have weight loss.
排除标准
- •Participating in a research project involving weight loss or physical activity in the previous six months.
- •Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- •Taking medication that could affect metabolism or change body weight.
- •Report heart problems, chest pain, and cancer within the last five years.
- •Menopause
- •Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
结局指标
主要结局
weight loss
时间窗: 12 Weeks
kg
次要结局
- Fasting plasma glucose level(12 Weeks)
- lipid profiles(12 Weeks)
- Body mass index reduction(12 Weeks)
- Insulin resistance (HOMA)(12 Weeks)
- liver enzymes (SGOT, SGPT)(12 Weeks)
研究者
研究点 (2)
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