Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Body fat percentage change
研究概览
简要总结
Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators will evaluate the effects of H2 intervention on body composition, hormonal status, and mitochondrial function in middle age overweight women, with hydrogen administered orally for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age > 55 years
- •body mass index > 25 kg/m2
排除标准
- •no history of H2 supplementation within the 4 weeks before study commenced
- •no major chronic diseases, as evaluated by pre-participation health screening and clinical chemistry
研究组 & 干预措施
Placebo
Cellulose, tablet, 2 g/day, 4 weeks
干预措施: Placebo (Dietary Supplement)
Molecular hydrogen
Molecular hydrogen, tablet, 2 g/day, 4 weeks
干预措施: Molecular hydrogen (Dietary Supplement)
结局指标
主要结局
Body fat percentage change
时间窗: Baseline vs. four weeks
Baseline vs. four weeks
次要结局
- Serum insulin change in IU/mL(Baseline vs. four weeks)
研究者
Assoc. Prof. Sergej M. Ostojic, MD, PhD
Principal Investigator
Center for Health, Exercise and Sport Sciences, Serbia