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Completed

NCT Number: NCT05910047

Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in 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.

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Key information

Conditions

Age-associated Memory Impairment

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplement

Dietary Supplement

Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone

Placebo

Dietary Supplement

Inert substance

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Irisin

    Time frame: Change from baseline serum irisin at 6 weeks

    Level of irisin in serum

  4. General cognition

    Time frame: Change from baseline MMSE score at 6 weeks

    Mini-MentalStateExamination (MMSE) score

  5. Brain creatine

    Time frame: Change from baseline brain creatine at 6 weeks

    MRS spectra for brain creatine

  6. Brain oxygenation

    Time frame: Change from baseline brain oxygenation at 6 weeks

    Near-infrared spectroscopy for prefrontal oxygen saturation

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study 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

Acronym: CALERIE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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