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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement | Experimental | One tablet of supplement before breakfast and dinner |
|
| Placebo | Placebo Comparator | One tablet of inert compound before breakfast and dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement | Dietary Supplement | Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibroblast growth factor 21 | Level of fibroblast growth factor 21 in serum | Change from baseline serum fibroblast growth factor 21 at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Brain-derived neurotrophic factor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSPE Applied Bioenergetics Lab | Novi Sad | Vojvodina | 21000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34601077 | Background | 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. | |
| 32632247 |
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Data obtained through this study may be provided to qualified researchers with academic interest in age-related mild cognitive impairment. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Dietary Supplement | Inert substance |
|
Level of brain-derived neurotrophic factor in serum |
| Change from baseline serum brain-derived neurotrophic factor at 6 weeks |
| Irisin | Level of irisin in serum | Change from baseline serum irisin at 6 weeks |
| General cognition | Mini-MentalStateExamination (MMSE) score | Change from baseline MMSE score at 6 weeks |
| Brain creatine | MRS spectra for brain creatine | Change from baseline brain creatine at 6 weeks |
| Brain oxygenation | Near-infrared spectroscopy for prefrontal oxygen saturation | Change from baseline brain oxygenation at 6 weeks |
| Background |
| 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. |
| 34654221 | Background | 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. |
| 28560519 | Background | 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. |
| 25720951 | Background | 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. |