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Molecular Hydrogen for Cognitive Function and Performance in Elderly

NCT ID: NCT02830854

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Impairments Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Molecular Hydrogen

Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks

Group Type EXPERIMENTAL

Molecular Hydrogen

Intervention Type OTHER

Interventions

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Molecular Hydrogen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age over 65
* No psychiatric comorbidities

Exclusion Criteria

* Use of dietary supplements 4 weeks before study commence
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, Serbia

Site Status

Countries

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Serbia

References

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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.

Reference Type BACKGROUND
PMID: 25936365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25720951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22720117 (View on PubMed)

Other Identifiers

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DK-DR16-02

Identifier Type: -

Identifier Source: org_study_id