Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05910047
Other study ID # A13-CH-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date March 31, 2024

Study information

Verified date February 2024
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date March 31, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Supplement
Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone
Placebo
Inert substance

Locations

Country Name City State
Serbia FSPE Applied Bioenergetics Lab Novi Sad Vojvodina

Sponsors (1)

Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fibroblast growth factor 21 Level of fibroblast growth factor 21 in serum Change from baseline serum fibroblast growth factor 21 at 6 weeks
Secondary Peroxisome proliferator-activated receptor gamma coactivator 1-alpha Level of peroxisome proliferator-activated receptor gamma coactivator 1-alpha 21 in serum Change from baseline serum peroxisome proliferator-activated receptor gamma coactivator 1-alpha at 6 weeks
Secondary Brain-derived neurotrophic factor Level of brain-derived neurotrophic factor in serum Change from baseline serum brain-derived neurotrophic factor at 6 weeks
Secondary Irisin Level of irisin in serum Change from baseline serum irisin at 6 weeks
Secondary General cognition Mini-MentalStateExamination (MMSE) score Change from baseline MMSE score at 6 weeks
Secondary Brain creatine MRS spectra for brain creatine Change from baseline brain creatine at 6 weeks
Secondary Brain oxygenation Near-infrared spectroscopy for prefrontal oxygen saturation Change from baseline brain oxygenation at 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT01429103 - Hormones and Cognition in the Menopausal Transition N/A
Completed NCT05759910 - Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals N/A
Completed NCT00355550 - Tricaprilin In Age-Associated Memory Impairment Phase 2
Terminated NCT05462782 - TMS for Investigating Memory Facilitation N/A
Recruiting NCT05934344 - Effectiveness of an Intervention Using Observation/Action Therapy Among Patients With Mild Cognitive Impairment N/A