Hydrogen-Rich Water and Exercise-Related Biomarkers in Men and Women Over 50 Years (HYDRORES)

December 28, 2023 updated by: Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

The Effects of Drinking Hydrogen-rich Water for 6 Weeks on Exercise-related Biomarkers in Men and Women Over 50 Years Following Resistance Training Program: a Randomized Controlled Pilot Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • FSPE Applied Bioenergetics Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement
One tablet of hydrogen-rich supplement before breakfast and dinner
Dietary supplement: Supplement
Dietary supplement containing molecular hydrogen
Placebo Comparator: Placebo
One tablet of hydrogen-free supplement before breakfast and dinner
Dietary supplement: Placebo
Inert substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Health Survey
Time Frame: Change from baseline 36-Item Short Form Health Survey total score at 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Change from baseline grip strength at 6 weeks
Muscular strength generated by one's forearm muscles
Change from baseline grip strength at 6 weeks
Myoglobin
Time Frame: Change from baseline serum myoglobine at 6 weeks
Level of myoglobin in serum
Change from baseline serum myoglobine at 6 weeks
Dehydroepiandrosterone
Time Frame: Change from baseline serum dehydroepiandrosterone at 6 weeks
Level of dehydroepiandrosterone in serum
Change from baseline serum dehydroepiandrosterone at 6 weeks
Pittsburgh Sleep Quality Index
Time Frame: Change from baseline Pittsburgh Sleep Quality Index score at 6 weeks
Pittsburgh Sleep Quality Index score, a score ranging from 0 to 3, with 3 indicating the greatest dysfunction
Change from baseline Pittsburgh Sleep Quality Index score at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Investigators

  • Principal Investigator: Sergej Ostojic, MD, PhD, University of Novi Sad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HRW-1-23-AL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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