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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06163287
Other study ID # HRW-1-23-AL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date March 31, 2024

Study information

Verified date December 2023
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Supplement
Dietary supplement containing molecular hydrogen
Placebo
Inert substance

Locations

Country Name City State
Serbia FSPE Applied Bioenergetics Lab Novi Sad Vojvodina

Sponsors (1)

Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Grip strength Muscular strength generated by one's forearm muscles Change from baseline grip strength at 6 weeks
Secondary Myoglobin Level of myoglobin in serum Change from baseline serum myoglobine at 6 weeks
Secondary Pittsburgh Sleep Quality Index 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
Secondary Dehydroepiandrosterone Level of dehydroepiandrosterone in serum Change from baseline serum dehydroepiandrosterone at 6 weeks
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