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Abstract

We analyzed the effects of 4-week H2 inhalation on cognitive performance in women aged 65 and above. The participants (n = 13) were community-dwelling older women (age 68.0 ± 3.0 years; weight 66.9 ± 10.3 kg; height 161.1 ± 5.8 cm) who volunteered to participate in this open-label pilot trial (ClinicalTrials.gov, NCT02830854). The participants received H2 by inhalation for 15 min once per day for 4 weeks. The cognitive function was assessed using the Mini Mental State Exam (MMSE) and Alzheimer disease assessment scale cognitive subscale (ADAS-Cog) at baseline and at follow up. H2 intervention significantly increased total MMSE scores (for 14.2% on average; p < 0.01), thereby improving cognitive function from mild dementia at baseline (a score of 25.6 out of 30) to normal cognition at follow up (above a cut score of 27). In addition, ADAS-Cog scores were significantly improved by H2 inhalation, with better performance for word recall test (p < 0.01), and improved word recognition (p = 0.01) at post-administration, respectively. This pilot trial seems to corroborate previous animal studies, suggesting that gaseous H2 might be considered as a beneficial agent for age-related cognitive health.
1. Introduction
A decline in cognitive function accompanies aging as one of the
most distinctive and hard-to-manage features of the process of
growing old. Many different pharmacological and non-pharmaco-
logical procedures have been used to tackle age-related cognitive
impairment in clinical environment with mixed results.1Molecular
hydrogen (H2) is a novel biomedical gas with polyvalent therapeutic
properties.2H2has recently been reported to alleviate cognitive
impairment and neurodegeneration in several animal models,3–5
yet no studies so far evaluated its effectiveness in human trials. In
this open-label pilot study, we analyzed the effects of 4-week H2
inhalation on cognitive performance in women aged 65 and above.
2. Methods
The participants (n= 13) were community-dwelling older
women (age 68.0 ±3.0 years; weight 66.9 ±10.3 kg; height 161.1 ±
5.8 cm) who volunteered to participate in this open-label pilot trial
(registered at ClinicalTrials.gov, NCT02830854). Exclusion criteria in-
cluded the presence of serious disease or psychiatric comorbidity.
The study was conducted according to the guidelines of the De-
claration of Helsinki, with local institutional review board approved
the study protocol. All participants gave their informed consent, and
were asked to maintain their usual lifestyle and dietary intake during
the study. The participants received H2by inhalation for 15 min once
per day for 4 weeks. Gaseous H2(4%) was provided by biological gas
supplying apparatus (MIZ Company Ltd, Kanagawa, Japan), with
day-to-day H2inhalation supervised by study investigators through-
out the trial. The primary endpoint of treatment efficacy was the
change in the Mini Mental State Exam (MMSE) score from baseline
to week 4. Additionally, assessment of other cognition markers and
side-effects evaluation were performed at baseline and after 4
weeks after study commence. The cognitive function of participants
was assessed using the MMSE and Alzheimer disease assessment
scale cognitive subscale (ADAS-Cog). MMSE is a 30-point question-
naire that is used extensively in clinical and research settings to mea-
sure cognitive impairment in elderly.6ADAS-Cog is a cognitive test-
ing instrument that consists of 11 tasks measuring the disturbances
of memory, language, praxis, attention and other cognitive abilities
in the assessment of dementia.6In addition to above tests, partici-
pants were instructed to report any adverse events of H2interven-
tion through an open-ended questionnaire for self-assessment of
side effects (e.g. nausea, headache) during the study. Wilcoxon
signed rank test was used to establish if any significant differences
existed between participants’ responses over time of intervention
(baseline vs. post-administration). Significance level was set at p£
0.05.
3. Results
All participants completed the follow-up measures, with no
participants were excluded from the study due to adverse events, or
reported any side effect of H2intervention. The compliance with the
regimen was 95.8%. Changes in cognitive function outcomes during
the study (baseline vs. 4-week follow up) are presented in Table.
H2intervention significantly increased total MMSE scores (for
14.2% on average; p< 0.01), thereby improving cognitive function
from mild dementia at baseline (a score of 25.6 out of 30) to normal
International Journal of Gerontology 14 (2020) 149-150
https://doi.org/10.6890/IJGE.202005_14(2).0013
Brief Communication
Short-Term H2Inhalation Improves Cognitive Function in Older Women: A Pilot Study
Darinka Korovljev, Tatjana Trivic, Valdemar Òtajer, Patrik Drid, Bunpei Sato, Sergej Ostojic *
Faculty of Sport and Physical Education, University of Novi Sad, Lovcenska 16, Novi Sad, Serbia
ARTICLE INFO
Accepted 2 October 2018
Keywords:
molecular hydrogen,
cognitive health,
older women
SUMMARY
We analyzed the effects of 4-week H2inhalation on cognitive performance in women aged 65 and
above. The participants (n= 13) were community-dwelling older women (age 68.0 ±3.0 years; weight
66.9 ±10.3 kg; height 161.1 ±5.8 cm) who volunteered to participate in this open-label pilot trial
(ClinicalTrials.gov, NCT02830854). The participants received H2by inhalation for 15 min once per day for
4 weeks. The cognitive function was assessed using the Mini Mental State Exam (MMSE) and Alzheimer
disease assessment scale cognitive subscale (ADAS-Cog) at baseline and at follow up. H2intervention
significantly increased total MMSE scores (for 14.2% on average; p< 0.01), thereby improving cognitive
function from mild dementia at baseline (a score of 25.6 out of 30) to normal cognition at follow up
(above a cut score of 27). In addition, ADAS-Cog scores were significantly improved by H2inhalation,
with better performance for word recall test (p< 0.01), and improved word recognition (p= 0.01) at
post-administration, respectively. This pilot trial seems to corroborate previous animal studies, sug-
gesting that gaseous H2might be considered as a beneficial agent for age-related cognitive health.
Copyright ©2020, Taiwan Society of Geriatric Emergency & Critical Care Medicine.
International Journal of Gerontology
journal homepage: http://www.sgecm.org.tw/ijge/
* Corresponding author.
E-mail address: sergej.ostojic@chess.edu.rs (S. Ostojic)
cognition at follow up (above a cut score of 27). In addition,
ADAS-Cog scores were significantly improved by H2inhalation, with
better performance for word recall test (p< 0.01), and improved
word recognition (p= 0.01) at post-administration, respectively.
Other nine domains of ADAS-Cog scores (naming task, commands,
constructional praxis, ideational praxis, orientation, spoken lan-
guage ability, remembering test instructions, word-finding difficulty,
and comprehension) were performed correctly (e.g. score = 0) at
both assessment periods (not presented).
4. Discussion
In this first-in-human, open-label trial of H2efficacy for cog-
nitive performance in elderly, a daily inhalation of 15 min of gaseous
H2for four weeks improved selected markers of cognition in a cohort
of apparently healthy women aged 65 and above. Twelve women
(out of 13) displayed higher MMSE scores at post-administration,
while enhanced word-sensitive cognition was reported in ADAS-Cog
test after H2intervention. In addition, inhaling H2appeared to have
acceptable safety profiles, with no evidence of subjectively reported
side effects. This pilot trial seems to corroborate previous animal
studies, suggesting that gaseous H2might be considered as a
beneficial agent for age-related cognitive health. Cognitive im-
pairment appears to be closely related to oxidative stress in elderly.7
Since exogenous H2acts as a selective antioxidant,2it might help to
maintain or retrieve redox balance within the central nervous sys-
tem, and promote cognitive longevity. Nagata and co-workers re-
ported that consumption of H2reduces oxidative stress in the brain,
and prevents oxidative stress-induced decline in hippocampus-
dependent learning and memory tasks in mice.3Besides anti-
oxidant effect, H2is also reported having an anti-inflammatory and
anti-apoptosis effect, an anti-allergic action, a lipid metabolism-
improving effect, a neuroprotective effect, and an intracellular
signaling regulatory effect.8These diverse effects would also con-
tribute to the improvement of cognitive impairment, and the ac-
curate mechanism of H2to affect cognition requires future re-
search. However, several limitations must be considered when study
findings are interpreted. The study population included only female
participants; it remains unknown whether gaseous H2affects cog-
nitive performance in older men and if gender-based differences
occur in response to H2inhalation. Other limitations include rela-
tively small sample size and no control or placebo-control group.
Finally, a 4-week study is perhaps too short to exam the lasting ef-
fect of cognitive benefit and to avoid the possibility of practice effect
when repeated during serial cognitive tests. Hence, randomized con-
trolled trials are highly warranted to substantiate this cognition-
boosting power of gaseous H2in humans, with other markers of cog-
nitive function (e.g. functional neuroimaging, cerebrospinal fluid
and blood-based biomarkers) monitored during the intervention, as
well as further validation in larger samples. If proven effective and
safe in well-designed human trials, gaseous H2might be considered
as an innovative therapeutic agent for other cognitive disorders,
including amnesia, Alzheimer’s disease or vascular dementia in the
future.
Funding
This work was supported by the Serbian Ministry of Education,
Science and Technological Development (Grant # 175037), and the
Provincial Secretariat for Science and Technological Development
(Grant # 114-451-710/2016-03). The funders had no role in study
design, data collection, analysis, and interpretation, decision to
publish, or preparation of the manuscript.
Conflict of interest
The authors declare no conflict of interest.
References
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150 D. Korovljev et al.
Table
Changes in cognitive performance after H2inhalation in older women (n= 13). Values are mean ±SD.
Baseline At 4 weeks % Change (95% CI) p
MMSE
Total score 25.6 ±1.6029.1 ±1.1014.2 (8.6 to 19.8) < 0.001
ADAS-Cog
Word recall task 3.6 ±1.0 8.1 ±1.2 140.0 (94.4 to 185.6) < 0.001
Word recognition* 4.2 ±3.2 1.1 ±1.0 -40.1 (-93.3 to 13.1) 0.01
Abbreviations. MMSE, Mini Mental State Examination; ADAS-Cog, Alzheimer's disease assessment scale-cognitive subscale; CI, confidence interval.
* Lower score means better word recognition.
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Screening for cognitive impairment in older adults: An evidence update for the U.S. Preventive Services Task Force
  • J S Lin
  • E O'connor
  • R C Rossom
Lin JS, O'Connor E, Rossom RC, et al. Screening for cognitive impairment in older adults: An evidence update for the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 2013 (Evidence Report No. 107. AHRQ Publication No. 14-05198-EF-1).