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

NCT05910047 | Completed

• 1 other identifier: A13-CH-2023
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-associated Memory Impairment

Keywords

MITOCHONDRIAL BIOMARKERS; BRAIN METABOLISM; COGNITION

Outcome Measures

Primary Outcomes (1)

• Fibroblast growth factor 21

  Level of fibroblast growth factor 21 in serum

  Change from baseline serum fibroblast growth factor 21 at 6 weeks

Secondary Outcomes (6)

• Peroxisome proliferator-activated receptor gamma coactivator 1-alpha

  Change from baseline serum peroxisome proliferator-activated receptor gamma coactivator 1-alpha at 6 weeks

• Brain-derived neurotrophic factor

  Change from baseline serum brain-derived neurotrophic factor at 6 weeks

• Irisin

  Change from baseline serum irisin at 6 weeks

• General cognition

  Change from baseline MMSE score at 6 weeks

• Brain creatine

  Change from baseline brain creatine at 6 weeks

Study Arms (2)

Supplement

EXPERIMENTAL

One tablet of supplement before breakfast and dinner

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

One tablet of inert compound before breakfast and dinner

Dietary Supplement: Placebo

Interventions

Supplement DIETARY_SUPPLEMENT

Dietary supplement containing molecular hydrogen and pyrroloquinoline quinone

Supplement

Placebo DIETARY_SUPPLEMENT

Inert substance

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 65 years
• MMSE scores ranged from 23-27
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (1)

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (5)

• 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.

  PMID: 34601077 BACKGROUND

• 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.

  PMID: 32632247 BACKGROUND

• 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.

  PMID: 34654221 BACKGROUND

• 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.

  PMID: 28560519 BACKGROUND

• 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.

  PMID: 25720951 BACKGROUND

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: September 1, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

SE (1)