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

February 5, 2024 updated by: Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Recruiting
        • FSPE Applied Bioenergetics Lab
        • Contact:
        • Sub-Investigator:
          • Darinka Korovljev, PhD
        • Sub-Investigator:
          • Valdemar Stajer, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement
One tablet of supplement before breakfast and dinner
Dietary supplement: Supplement
Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone
Placebo Comparator: Placebo
One tablet of inert compound before breakfast and dinner
Dietary supplement: Placebo
Inert substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline serum fibroblast growth factor 21 at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Change from baseline serum brain-derived neurotrophic factor at 6 weeks
Level of brain-derived neurotrophic factor in serum
Change from baseline serum brain-derived neurotrophic factor at 6 weeks
Irisin
Time Frame: Change from baseline serum irisin at 6 weeks
Level of irisin in serum
Change from baseline serum irisin at 6 weeks
General cognition
Time Frame: Change from baseline MMSE score at 6 weeks
Mini-MentalStateExamination (MMSE) score
Change from baseline MMSE score at 6 weeks
Brain creatine
Time Frame: Change from baseline brain creatine at 6 weeks
MRS spectra for brain creatine
Change from baseline brain creatine at 6 weeks
Brain oxygenation
Time Frame: Change from baseline brain oxygenation at 6 weeks
Near-infrared spectroscopy for prefrontal oxygen saturation
Change from baseline brain oxygenation at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A13-CH-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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