Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight (HOPE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Apolipoprotein B
研究概览
简要总结
The Supersaturated Hydrogen-Rich Water for Outpatients with Persistent Excess Weight (HOPE) study is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of daily consumption of supersaturated hydrogen-rich water in adults with persistent excess body weight. The trial investigates whether sustained exposure to molecular hydrogen can favorably influence body composition and key metabolic outcomes compared with a placebo water lacking dissolved hydrogen. By enrolling outpatients across multiple centers and applying rigorous blinding and randomization procedures, HOPE aims to generate high-quality clinical evidence on the potential role of hydrogen-rich water as a non-pharmacological, adjunctive strategy for weight management and metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Body mass index > 25.0 kg/m2 (persisted for at least six months before screening)
- •Stable on their therapy (if any) for ≥ 3 months
- •Free of acute disorders and severe chronic diseases
- •Informed consent signed
- •Normal fasting breath hydrogen levels < 15 ppm
排除标准
- •History of dietary supplement use 4 weeks before the study commences
- •Abnormal values for lab clinical chemistry not related with stiyd outcomes (> 2 SD)
- •No consent to randomization
- •Unwillingness to return for follow-up analysis
- •Participation in other clinical trials
- •Participants starting or changing major treatments during the study period
研究组 & 干预措施
Hydrogen-rich water
1.0 L of hydrogen-rich water per day
干预措施: Hydrogen-rich water (Dietary Supplement)
Control
1.0 L of hydrogen-free water per day
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Apolipoprotein B
时间窗: Change from baseline apolipoprotein B at 6 months
Serum level of apolipoprotein B
次要结局
- Lipoprotein (a)(Change from baseline lipoprotein (a) at 6 months)
- GLP-1(Change from baseline GLP-1 at 6 months)
- Short-chain fatty acids(Change from baseline short-chain fatty acids at 6 months)