Prospective Randomized Pilot Study of the Effects of Cold Vests on Cardiovascular Risk Markers and Basal Metabolic Rate
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
- 1
- 主要终点
- Composite measure of cardiovascular risk factors
研究概览
简要总结
Randomized trial of supplying a cold vest as compared with controls (no cold vest) on cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are checked at baseline, after 2 months and after 1 year.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects that have no known metabolic relevant diseases
排除标准
- •thyroid disease,
- •mental disorders,
- •language problems
研究组 & 干预措施
cold vest
Participants are given a cold vest that the pre-cool in a freezer. They are encouraged to use it daily to activate metabolism through brown adipose tissue and shivering.
干预措施: cold vest (Other)
control
No intervention, just recording of risk factors and basal metabolic rate.
结局指标
主要结局
Composite measure of cardiovascular risk factors
时间窗: up to 1 year
Blood lipids, insulin, body weight, blood pressure
basal metabolic rate
时间窗: up to 1 year
basal metabolic rate measured in the fasting state by indirect calorimetry
次要结局
未报告次要终点
研究者
Fredrik H Nystrom
Professor
University Hospital, Linkoeping