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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202469
Other study ID # CR-24-AK15
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2023
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact Sergej Ostojic, MD, PhD
Phone +38121450188
Email sergej.ostojci@chess.edu.rs
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date June 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Age 18 - 35 years - Sperm quality test available (at least half will have low sperm quality) - Informed consent - Healthy BMI (18.5 - 24.9 kg/m2) Exclusion Criteria: - Major chronic disease and acute injuries - History of dietary supplement use during the past 28 days - No consent to randomization - Participation in other studies

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Supplement 1
Creatine monohydrate (5 g/day)
Supplement 2
Creatine monohydrate (5 g/day) plus ubiquinol (200 mg/day)
Placebo
Placebo (inulin)

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 (1)

Ostojic SM, Stea TH, Engeset D. Creatine as a Promising Component of Paternal Preconception Diet. Nutrients. 2022 Jan 28;14(3):586. doi: 10.3390/nu14030586. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sperm concentration Number of sperm per milliliter of semen Change from baseline sperm concentration at 8 weeks
Secondary Total antioxidant capacity Level of total antioxidant capacity in semen Change from baseline total antioxidant capacity at 8 weeks
Secondary Creatine kinase Level of creatine kinase in semen Change from baseline creatine kinase at 8 weeks
Secondary Creatine Level of creatine in semen Change from baseline creatine at 8 weeks
Secondary The World Health Organisation-Five Well-Being Index (WHO-5) The World Health Organisation-Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The raw scores are transformed to a score from 0 to 100, with lower scores indicating worse well-being. Change from baseline WHO-5 at 8 weeks
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