Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight

Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight (HOPE)

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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