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

Age-associated Memory Impairment Clinical Trial

— CALERIE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910047
• Other study ID #: A13-CH-2023
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Age-associated Memory Impairment
• Cognitive Dysfunction

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