Creatine and Ubiquinol for Sperm Quality (CRESPAQ10)

The Effects of 8-week Creatine Supplementation With and Without Ubiquinol on Sperm Quality Biomarkers in Normospermic and Oligospermic Men

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.

Study Overview

• Status: Recruiting
• Conditions: Oligospermia; Sperm Count, Low
• Intervention / Treatment: Dietary supplement: Supplement 1; Dietary supplement: Supplement 2; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergej Ostojic, MD, PhD; Phone Number: +38121450188; Email: sergej.ostojci@chess.edu.rs

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Recruiting
      • FSPE Applied Bioenergetics Lab
      • Contact: Sergej M Ostojic, MD, PhD; Phone Number: +38121450188; Email: sergej.ostojic@chess.edu.rs
      • Sub-Investigator: Darinka Korovljev, PhD
      • Sub-Investigator: Valdemar Stajer, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplement 1; Creatine monohydrate	Dietary supplement: Supplement 1; Creatine monohydrate (5 g/day)
Experimental: Supplement 2; Creatine monohydrate plus ubiquinol	Dietary supplement: Supplement 2; Creatine monohydrate (5 g/day) plus ubiquinol (200 mg/day)
Placebo Comparator: Placebo; Inulin	Dietary supplement: Placebo; Placebo (inulin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm concentration	Number of sperm per milliliter of semen	Change from baseline sperm concentration at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total antioxidant capacity	Level of total antioxidant capacity in semen	Change from baseline total antioxidant capacity at 8 weeks
Creatine kinase	Level of creatine kinase in semen	Change from baseline creatine kinase at 8 weeks
Creatine	Level of creatine in semen	Change from baseline creatine at 8 weeks
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

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Oligospermia
• Other Study ID Numbers: CR-24-AK15

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 sperm quality. 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 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.
• IPD Sharing Access Criteria: Only qualified researchers with academic interest in sperm quality
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; 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