The effects of ingestion of hydrogen-dissolved alkaline electrolyzed water on stool consistency and gut microbiota: a double-blind randomized trial.
Yoshinori Tanaka, Masataka Kiuchi, Yasuki Higashimura, Yuji Naito, Katsuhiro Koyama · Medical gas research · 2021
Research-use notice
Independent study record
Each H2HUBB study page organizes source-linked research details for educational use. Interpretation should remain proportional to the study design, population, controls, and limitations.
H2HUBB TAKEAWAY
In the study, the researchers performed a comparative evaluation of two groups with largely equal (i.e., no significant difference) relative abundances of Bifidobacterium who drank either AEW containing hydrogen or PW, and were thereby able to confirm an increase in the Bifidobacterium population in the intestine as a result of drinking AEW. These findings add human evidence that helps define the outcomes that did and did not change with molecular hydrogen in this study.
What the Findings Mean
H2HUBB reviewed how molecular hydrogen affected the outcomes measured in The participants drank 500 mL of purified tap water or AEW every day for 2 weeks. In the study, the researchers performed a comparative evaluation of two groups with largely equal (i.e., no significant difference) relative abundances of Bifidobacterium who drank either AEW containing hydrogen or PW, and were thereby able to confirm an increase in the Bifidobacterium population in the intestine as a result of drinking AEW.
What the Researchers Studied
The researchers studied The participants drank 500 mL of purified tap water or AEW every day for 2 weeks. The study used a randomized, double-blind human clinical trial.
What Effects Did Molecular Hydrogen Have?
Reported treatment duration: 2 weeks. In the study, the researchers performed a comparative evaluation of two groups with largely equal (i.e., no significant difference) relative abundances of Bifidobacterium who drank either AEW containing hydrogen or PW, and were thereby able to confirm an increase in the Bifidobacterium population in the intestine as a result of drinking AEW. It can be hypothesized that hydrogen molecules, which exhibit antioxidant action, are involved in this oxidation/antioxidation pathway, and that this acts as an indirect growth factor for Bifidobacteria, which are highly sensitive to oxygen.
Why These Findings Matter
This publication adds useful evidence about where molecular hydrogen did and did not change the measured outcomes, helping define the larger therapeutic evidence base.
How Strong Is This Evidence?
This is human clinical evidence from a randomized, double-blind human clinical trial. H2HUBB interprets the findings in the context of the study design, sample, comparator, and measured outcomes rather than using one publication as a verdict on hydrogen therapy.
Technical Study Details
H2HUBB classifies this publication as human clinical study with human clinical evidence. The research population or model was The participants drank 500 mL of purified tap water or AEW every day for 2 weeks. The reported sample size was 20. The study used a randomized, double-blind human clinical trial. The reported treatment duration was 2 weeks.
Limitations and Safety
Reported limitations: CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Item No Checklist item Reported on page No Title and abstract 1a Identification as a randomised trial in the title 1 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 1 Introduction Background and 2a Scientific background and explanation of rationale 2-3 objectives 2b Specific objectives or hypotheses 3 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 4 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 4 Participants 4a Eligibility criteria for participants 4 4b Settings and locations where the data were collected 4 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 4 Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 6-8 6b Any changes to trial outcomes after the trial commenced, with reasons N/A Sample size 7a How sample size was determined 4 7b When applicable, explanation of any interim analyses and stopping guidelines N/A Randomisation: Sequence generation 8a Method used to generate the random allocation sequence 4 8b Type of randomisation. Details of any restriction (such as blocking and block size) 4 Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 4 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 4 Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 4 11b If relevant, description of the similarity of interventions N/A Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 8 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses N/A Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome 5 13b For each group, losses and exclusions after randomisation, together with reasons N/A Recruitment 14a Dates defining the periods of recruitment and follow-up 2 14b Why the trial ended or was stopped N/A Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 5 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 11-13 Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 11-14 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended N/A Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory NA Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) NA Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 15-16 Generalisability 21 Generalisability (external validity, applicability) of the trial findings 15-16 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 15-16 Other information Registration 23 Registration number and name of trial registry 16 Protocol 24 Where the full trial protocol can be accessed, if available 16 Funding 25 Sources of funding and other support (such as supply of drugs), role of funders 16 *the researchers strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items.
Original Study and H2HUBB Research Context
H2HUBB presents this source-grounded research record as one contribution to the broader molecular-hydrogen evidence base.