Molecular Hydrogen for Cognitive Function and Performance in Elderly

NCT02830854 — Phase 3, Completed, 13 participants, University of Novi Sad, Faculty of Sport and Physical Education

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RegistryNCT02830854
StatusCompleted
PhasePhase 3
Study typeInterventional; na, single group, masking: none, supportive care
Enrollment13 (Actual)
SponsorUniversity of Novi Sad, Faculty of Sport and Physical Education (Other)
ConditionsCognitive Impairments, Aging
InterventionsMolecular Hydrogen (Other)
Datesstart 2016-07-01, primary completion 2016-09-01, completion 2016-09-01, first posted 2016-07-13, last updated 2016-10-28
Locations1 site in Serbia

Related Papers Related Patents Related Grants Related Experts
All trials for Cognitive Impairments All trials for Aging All trials of Molecular Hydrogen

-Summary

A variety of non-pharmacological interventions have been used in the management of Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. Although it is still unknown what triggers AD, recent studies have shown that AD is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis to be evaluated in this project is that administration of H2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from AD.

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+Arms and interventions

ArmTypeInterventionsDescription
Molecular HydrogenExperimentalOther: Molecular HydrogenMolecular hydrogen: 20 min per day of 3% H2 during 4 weeks
  • Molecular Hydrogen (Other)

+Outcome measures

Primary outcomes

  • ADAS-Cog score for cognitive function [Change from Baseline ADAS-Cog Score at 4 weeks]: ADAS-Cog total score and scores for 4 separate cognitive domains (memory, orientation, praxis, and language) will be evaluated.

+Eligibility

Sex: All, ages: 65 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Age over 65
* No psychiatric comorbidities

Exclusion Criteria:

* Use of dietary supplements 4 weeks before study commence

+Locations (1)

FacilityCityCountryStatus
Applied Bioenergetics Lab at Faculty of Sport and PENovi Sad, VojvodinaSerbia

+Publications

  • Ostojic SM. Molecular hydrogen: An inert gas turns clinically effective. Ann Med. 2015 Jun;47(4):301-4. doi: 10.3109/07853890.2015.1034765. Epub 2015 May 4. PMID 25936365
  • Ostojic SM. Targeting molecular hydrogen to mitochondria: barriers and gateways. Pharmacol Res. 2015 Apr;94:51-3. doi: 10.1016/j.phrs.2015.02.004. Epub 2015 Feb 24. PMID 25720951
  • Ohno K, Ito M, Ichihara M, Ito M. Molecular hydrogen as an emerging therapeutic medical gas for neurodegenerative and other diseases. Oxid Med Cell Longev. 2012;2012:353152. doi: 10.1155/2012/353152. Epub 2012 Jun 8. PMID 22720117