Age-associated Memory Impairment Clinical Trial
— CALERIEOfficial 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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Serbia | FSPE Applied Bioenergetics Lab | Novi Sad | Vojvodina |
Lead Sponsor | Collaborator |
---|---|
University of Novi Sad, Faculty of Sport and Physical Education |
Serbia,
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
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 |
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