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

Not Applicable

Completed

• Conditions: Age-associated Memory Impairment
• Interventions: Dietary Supplement: Supplement; Dietary Supplement: Placebo

• Registration Number: NCT05910047
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Study Start: 2023-09-01
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplement	Supplement	One tablet of supplement before breakfast and dinner
Placebo	Placebo	One tablet of inert compound before breakfast and dinner

Primary Outcome Measures

Name	Time	Method
Fibroblast growth factor 21	Change from baseline serum fibroblast growth factor 21 at 6 weeks	Level of fibroblast growth factor 21 in serum

Secondary Outcome Measures

Name	Time	Method
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha	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
Brain creatine	Change from baseline brain creatine at 6 weeks	MRS spectra for brain creatine
Brain-derived neurotrophic factor	Change from baseline serum brain-derived neurotrophic factor at 6 weeks	Level of brain-derived neurotrophic factor in serum
Irisin	Change from baseline serum irisin at 6 weeks	Level of irisin in serum
General cognition	Change from baseline MMSE score at 6 weeks	Mini-MentalStateExamination (MMSE) score
Brain oxygenation	Change from baseline brain oxygenation at 6 weeks	Near-infrared spectroscopy for prefrontal oxygen saturation

Trial Locations

Locations (1)

FSPE Applied Bioenergetics Lab; 🇷🇸 Novi Sad, Vojvodina, Serbia