NCT06163287

Brief Summary

The study investigates the impact of consuming hydrogen-rich water over a six-week period on exercise-related biomarkers among individuals aged over 50, both men and women, who undergo a resistance training program. This research aims to discern the potential benefits of hydrogen-infused water consumption concerning exercise-related markers in an aging demographic post-resistance training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

November 30, 2023

Last Update Submit

December 3, 2024

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • 36-Item Short Form Health Survey

    Short Form Health Survey total score, minimum and maximum possible score of between 0 and 100, with higher scores mean better outcome

    Change from baseline 36-Item Short Form Health Survey total score at 6 weeks

Secondary Outcomes (4)

  • Grip strength

    Change from baseline grip strength at 6 weeks

  • Myoglobin

    Change from baseline serum myoglobine at 6 weeks

  • Pittsburgh Sleep Quality Index

    Change from baseline Pittsburgh Sleep Quality Index score at 6 weeks

  • Dehydroepiandrosterone

    Change from baseline serum dehydroepiandrosterone at 6 weeks

Study Arms (2)

Supplement

EXPERIMENTAL

One tablet of hydrogen-rich supplement before breakfast and dinner

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

One tablet of hydrogen-free supplement before breakfast and dinner

Dietary Supplement: Placebo

Interventions

SupplementDIETARY_SUPPLEMENT

Dietary supplement containing molecular hydrogen

Supplement
PlaceboDIETARY_SUPPLEMENT

Inert substance

Placebo

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 - 65 years (at least 50% would be over 60 years)
  • Body mass index 18.5 - 29.9 kg/m2
  • Free of major chronic diseases or acute disorders
  • Resistance exercise naïve (no resistance traiing during 6 months before study commences)

You may not qualify if:

  • History of dietary supplement use during the 4 weeks before study commences
  • Unwillingness to return for follow-up analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (3)

  • 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: 34601077BACKGROUND

  • 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: 28560519BACKGROUND

  • 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: 34654221BACKGROUND

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sergej Ostojic, MD, PhD

    University of Novi Sad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

October 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest in hydrogen research in biomedicine. 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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE(1)