MedDataX Logo

Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in Elderly With Mild Cognitive Impairment

NCT ID: NCT05910047

Last Updated: 2024-12-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of dietary supplementation with molecular hydrogen and pyrroloquinoline quinone in elderly. The main questions it aims to answer are: (1) whether the supplementation affects biomarkers of mitochondrial function in serum, and (2) whether the supplementation affects cognition and brain metabolism. The participants will be subjected to take the dietary supplement during 6 weeks.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age-associated Memory Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supplement

One tablet of supplement before breakfast and dinner

Group Type EXPERIMENTAL

Supplement

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone

Placebo

One tablet of inert compound before breakfast and dinner

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Inert substance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supplement

Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone

Intervention Type DIETARY_SUPPLEMENT

Placebo

Inert substance

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 65 years
* MMSE scores ranged from 23-27
* Informed consent signed

Exclusion Criteria

* Take part in exercise on a regular basis
* Severe chronic disease and acute injuries
* History of dietary supplement use during the past 4weeks
* No consent to randomization
* Participation in other studies
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sergej Ostojic

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, Serbia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Serbia

References

Explore related publications, articles, or registry entries linked to this study.

Zanini D, Todorovic N, Korovljev D, Stajer V, Ostojic J, Purac J, Kojic D, Vukasinovic E, Djordjievski S, Sopic M, Guzonjic A, Ninic A, Erceg S, Ostojic SM. The effects of 6-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in older adults aged 70 years and over: A randomized controlled pilot trial. Exp Gerontol. 2021 Nov;155:111574. doi: 10.1016/j.exger.2021.111574. Epub 2021 Oct 1.

Reference Type BACKGROUND
PMID: 34601077 (View on PubMed)

Ostojic SM. Does drinking water rich in hydrogen gas revive brain hypometabolism in neurodegeneration by SCFAs upregulation? Eur J Clin Nutr. 2021 Jan;75(1):212-213. doi: 10.1038/s41430-020-0680-x. Epub 2020 Jul 6. No abstract available.

Reference Type BACKGROUND
PMID: 32632247 (View on PubMed)

Korovljev D, Stajer V, Javorac D, Ostojic SM. Hydrogen inhalation positively affects cardiometabolic risk factors in men and women aged 65 years or older: a preliminary report. Eur Geriatr Med. 2018 Oct;9(5):729-730. doi: 10.1007/s41999-018-0087-6. Epub 2018 Jul 31. No abstract available.

Reference Type BACKGROUND
PMID: 34654221 (View on PubMed)

Korovljev D, Trivic T, Drid P, Ostojic SM. Molecular hydrogen affects body composition, metabolic profiles, and mitochondrial function in middle-aged overweight women. Ir J Med Sci. 2018 Feb;187(1):85-89. doi: 10.1007/s11845-017-1638-4. Epub 2017 May 30.

Reference Type BACKGROUND
PMID: 28560519 (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)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A13-CH-2023

Identifier Type: -

Identifier Source: org_study_id