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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Age-associated Memory Impairment

Intervention / Treatment
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* Dietary Supplement: Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibroblast growth factor 21 | 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 | 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 | Level of brain-derived neurotrophic factor in serum | Change from baseline serum brain-derived neurotrophic factor at 6 weeks | 
| Irisin | Level of irisin in serum | Change from baseline serum irisin at 6 weeks | 
| General cognition | Mini-MentalStateExamination (MMSE) score | Change from baseline MMSE score at 6 weeks | 
| Brain creatine | MRS spectra for brain creatine | Change from baseline brain creatine at 6 weeks | 
| Brain oxygenation | Near-infrared spectroscopy for prefrontal oxygen saturation | Change from baseline brain oxygenation at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MITOCHONDRIAL BIOMARKERS, BRAIN METABOLISM, COGNITION