Clinical trial NCT05910047: Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in Elderly With Mild Cognitive Impairment
Official title: The Effects of Six-week Hydrogen Plus Pyrroloquinoline Quinone (PQQ) Intake on Mitochondrial Biomarkers, Brain Metabolism and Cognition in the Elderly With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-associated Memory Impairment
Keywords: MITOCHONDRIAL BIOMARKERS
BRAIN METABOLISM
COGNITION
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fibroblast growth factor 21
timeFrame: Change from baseline serum fibroblast growth factor 21 at 6 weeks
Secondary outcomes:
measure: Peroxisome proliferator-activated receptor gamma coactivator 1-alpha
timeFrame: Change from baseline serum peroxisome proliferator-activated receptor gamma coactivator 1-alpha at 6 weeks
measure: Brain-derived neurotrophic factor
timeFrame: Change from baseline serum brain-derived neurotrophic factor at 6 weeks
measure: Irisin
timeFrame: Change from baseline serum irisin at 6 weeks
measure: General cognition
timeFrame: Change from baseline MMSE score at 6 weeks
measure: Brain creatine
timeFrame: Change from baseline brain creatine at 6 weeks
measure: Brain oxygenation
timeFrame: Change from baseline brain oxygenation at 6 weeks
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied Bioenergetics Lab
state: Vojvodina
Study officials:
References:
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.
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.
citation: 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.
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.
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.