Age-associated Memory ImpairmentCALERIENCT05910047
Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in Elderly With Mild Cognitive Impairment
A study testing Supplement in people with Age-associated Memory Impairment, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age-associated Memory Impairment
- What is being tested?
- Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Sep 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 65 years
- MMSE scores ranged from 23-27
- Informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Age-associated Memory Impairment
- Being tested
- Supplement, Placebo
- Keywords
- MITOCHONDRIAL BIOMARKERS, BRAIN METABOLISM, COGNITION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone
PlaceboDietary supplement
Inert substance
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | One tablet of supplement before breakfast and dinner Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | One tablet of inert compound before breakfast and dinner Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast growth factor 21
Level of fibroblast growth factor 21 in serum
Measured: Change from baseline serum fibroblast growth factor 21 at 6 weeks
Secondary outcomes (6)
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha
Level of peroxisome proliferator-activated receptor gamma coactivator 1-alpha 21 in serum
Measured: Change from baseline serum peroxisome proliferator-activated receptor gamma coactivator 1-alpha at 6 weeks
Brain-derived neurotrophic factor
Level of brain-derived neurotrophic factor in serum
Measured: Change from baseline serum brain-derived neurotrophic factor at 6 weeks
Irisin
Level of irisin in serum
Measured: Change from baseline serum irisin at 6 weeks
General cognition
Mini-MentalStateExamination (MMSE) score
Measured: Change from baseline MMSE score at 6 weeks
Brain creatine
MRS spectra for brain creatine
Measured: Change from baseline brain creatine at 6 weeks
Brain oxygenation
Near-infrared spectroscopy for prefrontal oxygen saturation
Measured: Change from baseline brain oxygenation at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Sep 2023
- Primary completion15 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Age-associated Memory ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910047
- Sponsor's protocol ID
- A13-CH-2023
- Acronym
- CALERIE
- Status last verified
- Dec 2024
- First submitted
- 8 Jun 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34601077Ostojic 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.
PubMed 32632247Korovljev 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.
PubMed 34654221Korovljev 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.
PubMed 28560519Ostojic 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.
PubMed 25720951Baltic S, Nedeljkovic D, Todorovic N, Ranisavljev M, Korovljev D, Cvejic J, Ostojic J, LeBaron TW, Timmcke J, Stajer V, Ostojic SM. The impact of six-week dihydrogen-pyrroloquinoline quinone supplementation on mitochondrial biomarkers, brain metabolism, and cognition in elderly individuals with mild cognitive impairment: a randomized controlled trial. J Nutr Health Aging. 2024 Aug;28(8):100287. doi: 10.1016/j.jnha.2024.100287. Epub 2024 Jun 21.
PubMed 38908296
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05910047
- Acronym / sponsor ID
- CALERIE / A13-CH-2023
- Conditions
- Age-associated Memory Impairment
- Keywords
- MITOCHONDRIAL BIOMARKERS, BRAIN METABOLISM, COGNITION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: SupplementOne tablet of supplement before breakfast and dinner |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne tablet of inert compound before breakfast and dinner |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age > 65 years
- MMSE scores ranged from 23-27
- Informed consent signed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementDietary supplement containing molecular hydrogen and pyrroloquinoline quinone | Dietary supplement | Supplement |
| PlaceboInert substance | Dietary supplement | Placebo |
Primary outcome
Fibroblast growth factor 21
Time frame: Change from baseline serum fibroblast growth factor 21 at 6 weeks
Level of fibroblast growth factor 21 in serum
6 secondary outcomes
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha
Time frame: Change from baseline serum peroxisome proliferator-activated receptor gamma coactivator 1-alpha at 6 weeks
Brain-derived neurotrophic factor
Time frame: Change from baseline serum brain-derived neurotrophic factor at 6 weeks
Irisin
Time frame: Change from baseline serum irisin at 6 weeks
General cognition
Time frame: Change from baseline MMSE score at 6 weeks
Brain creatine
Time frame: Change from baseline brain creatine at 6 weeks
Brain oxygenation
Time frame: Change from baseline brain oxygenation at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 34601077Zanini 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.
- Background: PubMed 32632247Ostojic 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.
- Background: PubMed 34654221Korovljev 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.
- Background: PubMed 28560519Korovljev 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.
- Background: PubMed 25720951Ostojic 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.
- Derived from this study: PubMed 38908296Baltic S, Nedeljkovic D, Todorovic N, Ranisavljev M, Korovljev D, Cvejic J, Ostojic J, LeBaron TW, Timmcke J, Stajer V, Ostojic SM. The impact of six-week dihydrogen-pyrroloquinoline quinone supplementation on mitochondrial biomarkers, brain metabolism, and cognition in elderly individuals with mild cognitive impairment: a randomized controlled trial. J Nutr Health Aging. 2024 Aug;28(8):100287. doi: 10.1016/j.jnha.2024.100287. Epub 2024 Jun 21.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Age-associated Memory Impairment
Recruiting
Physical Activity and Community EmPOWERment Project
Intellectual Disability, Neurodevelopmental Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Age-associated Memory Impairment, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast growth factor 21 (time frame: Change from baseline serum fibroblast growth factor 21 at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910047, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.