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

Primary Purpose

Age-associated Memory Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Supplement
Placebo
Sponsored by
University of Novi Sad, Faculty of Sport and Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Age-associated Memory Impairment focused on measuring MITOCHONDRIAL BIOMARKERS, BRAIN METABOLISM, COGNITION

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FSPE Applied Bioenergetics LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplement

Placebo

Arm Description

One tablet of supplement before breakfast and dinner

One tablet of inert compound before breakfast and dinner

Outcomes

Primary Outcome Measures

Fibroblast growth factor 21
Level of fibroblast growth factor 21 in serum

Secondary Outcome Measures

Peroxisome proliferator-activated receptor gamma coactivator 1-alpha
Level of peroxisome proliferator-activated receptor gamma coactivator 1-alpha 21 in serum
Brain-derived neurotrophic factor
Level of brain-derived neurotrophic factor in serum
Irisin
Level of irisin in serum
General cognition
Mini-MentalStateExamination (MMSE) score
Brain creatine
MRS spectra for brain creatine
Brain oxygenation
Near-infrared spectroscopy for prefrontal oxygen saturation

Full Information

First Posted
June 8, 2023
Last Updated
August 11, 2023
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
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1. Study Identification

Unique Protocol Identification Number
NCT05910047
Brief Title
Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in Elderly With Mild Cognitive Impairment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-associated Memory Impairment
Keywords
MITOCHONDRIAL BIOMARKERS, BRAIN METABOLISM, COGNITION

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplement
Arm Type
Experimental
Arm Description
One tablet of supplement before breakfast and dinner
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet of inert compound before breakfast and dinner
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement
Intervention Description
Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Inert substance
Primary Outcome Measure Information:
Title
Fibroblast growth factor 21
Description
Level of fibroblast growth factor 21 in serum
Time Frame
Change from baseline serum fibroblast growth factor 21 at 6 weeks
Secondary Outcome Measure Information:
Title
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha
Description
Level of peroxisome proliferator-activated receptor gamma coactivator 1-alpha 21 in serum
Time Frame
Change from baseline serum peroxisome proliferator-activated receptor gamma coactivator 1-alpha at 6 weeks
Title
Brain-derived neurotrophic factor
Description
Level of brain-derived neurotrophic factor in serum
Time Frame
Change from baseline serum brain-derived neurotrophic factor at 6 weeks
Title
Irisin
Description
Level of irisin in serum
Time Frame
Change from baseline serum irisin at 6 weeks
Title
General cognition
Description
Mini-MentalStateExamination (MMSE) score
Time Frame
Change from baseline MMSE score at 6 weeks
Title
Brain creatine
Description
MRS spectra for brain creatine
Time Frame
Change from baseline brain creatine at 6 weeks
Title
Brain oxygenation
Description
Near-infrared spectroscopy for prefrontal oxygen saturation
Time Frame
Change from baseline brain oxygenation at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
FSPE Applied Bioenergetics Lab
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergej M Ostojic, MD, PhD
Phone
+38121450188
Email
sergej.ostojic@chess.edu.rs
First Name & Middle Initial & Last Name & Degree
Darinka Korovljev, PhD
First Name & Middle Initial & Last Name & Degree
Valdemar Stajer, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
Citations:
PubMed Identifier
34601077
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.
Results Reference
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PubMed Identifier
32632247
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.
Results Reference
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PubMed Identifier
34654221
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.
Results Reference
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PubMed Identifier
28560519
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.
Results Reference
background
PubMed Identifier
25720951
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.
Results Reference
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Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in Elderly With Mild Cognitive Impairment

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