Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays at Room Temperature on Metabolic Profile in Adults: a RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Low density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks.
详细描述
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks; the safety of the compound are also evaluate. The Investigators examine lipid profile, glucose, liver and renal function at baseline, as well as after 4, 8 weeks of intervention. Thirty adults were administered either 1.8 L of drinking water using a tumbler that emits far infrared rays at room temperature or drinking water using a sham-tumbler each day for 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 years and older
排除标准
- •aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than twice the highest reference value
- •serum creatinine ≥ 1.5 mg/dL)
- •uncontrolled diabetes mellitus (a fasting glucose of >160 mg/dL)
- •uncontrolled hypertension (BP > 160/100 mmHg)
- •severe gastrointestinal symptoms
- •alcohol abuser
- •pregnant or lactating women
- •allergic to the ingredient involved
- •cardiocebrovascular diseases or any cancer during the six months prior to study
结局指标
主要结局
Low density lipoprotein cholesterol (LDL-C)
时间窗: Change from baseline level of LDL-C at 8 weeks
Change of LDL-C during 8 weeks
次要结局
- creatinine(Change from baseline level of creatinine at 8 weeks)
- body weight(Change from baseline level at 8 weeks)
- aspartate transaminase (AST)(Change from baseline level of AST at 8 weeks)
- free fatty acid(Change from baseline level at 8 weeks)
- homeostasis model assessment of insulin resistance (HOMA-IR)(Change from baseline level of HOMA-IR at 8 weeks)
- alanine transaminase (ALT)(Change from baseline level of ALT at 8 weeks)
研究者
Sang Yeoup Lee
Professor of Family Medicine
Pusan National University Yangsan Hospital