Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight
ConditionOverweight
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter for Health Sciences, Serbia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrogen-rich water
Dietary supplementHydrogen-rich water (1.0 L per day)
Control
Dietary supplementHydrogen-free water (1.0 L per day)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Hydrogen-rich waterExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Apolipoprotein B
Serum level of apolipoprotein B
Time frame
Change from baseline apolipoprotein B at 6 monthsSecondary outcomes
1
Lipoprotein (a)
Serum level of lipoprotein (a)
Time frame
Change from baseline lipoprotein (a) at 6 months2
GLP-1
Serum level of GLP-1
Time frame
Change from baseline GLP-1 at 6 months3
Short-chain fatty acids
Serum level of short-chain fatty acids
Time frame
Change from baseline short-chain fatty acids at 6 monthsOther outcomes
1
Fat mass
Body fat percentage
Time frame
Change from baseline body fat percentage at 6 months2
Fasting breath hydrogen
Breath levels of molecular hydrogen at fasting
Time frame
Change from baseline breath levels of molecular hydrogen at fasting at 6 months3
Post-prandial breath hydrogen
Breath levels of molecular hydrogen after meal
Time frame
Change from baseline breath levels of molecular hydrogen after meal at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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