- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07801924
Evaluation of the Effectiveness of Oral Ozonized Oil Supplementation in Elite Athletes
Evaluation of the Effects of Ozonated Oil Administration on Athletic Performance and Injury Prevention in Elite Athletes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
AQ
-
Avezzano, AQ, Italy, 67051
- Stadio del Rugby
-
-
Genova
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Genova, Genova, Italy, 16132
- University of Genova
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion criteria were age ≥18
Exclusion Criteria:
- NA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group (IG): received daily ozonized oil supplementation
The IG received the supplement of ozonized oil capsules (O3ZONE Sport ®). Dosage was standardized and adjusted according to body:
Both groups followed identical training protocols; the IG additionally received daily ozonized oil. Performance was assessed at baseline, 3 months, and 6 months using the Bronco test (field endurance), Bruce and Léger tests (estimated VO2max), the Running-Based Anaerobic Sprint Test (RAST), and tests of quadriceps and bench-press 1-repetition maximum (1RM) and endurance at 50% 1RM. Outcomes were expressed as percentage change from baseline |
, the present study aimed to investigate the potential effects of daily oral supplementation with ozonized oil (O3ZONE Sport®) (produced for O3 ZONE LIMITED, Acquaviva, RSM) on physical performance outcomes - aerobic capacity, maximal strength, muscular endurance, and functional fitness - in elite rugby players over a six-month training period.
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No Intervention: • Control group (CG): n = 15, which continued standard training without supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary objective was to investigate the effects of ozonated oil administration on athletic performance and injury prevention in a group of 21 rugby athletes, divided into two groups: Experimental group (n=13) vs Control group (n=8)
Time Frame: 1 year
|
Bruce test: which measures a subject's maximal oxygen consumption (VO2max).
VO2max represents the maximum aerobic power, that is, the maximum amount of energy that can be synthesized by the aerobic mechanism in a unit of time.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary objective was to investigate the effects of ozonated oil administration on athletic performance and injury prevention in a group of 21 rugby athletes, divided into two groups: Experimental group (n=13) vs Control group (n=8)
Time Frame: 1 year
|
Bronco test: is a 1,200 meter shuttle run designed to measure maximum aerobic speed (MAS) and endurance, primarily used in rugby.
The test requires athletes to complete five sets of 20 meter, 40 meter, and 60meter shuttle runs, totalling 1,200 meters as fast as possible
|
1 year
|
|
The primary objective was to investigate the effects of ozonated oil administration on athletic performance and injury prevention in a group of 21 rugby athletes, divided into two groups: Experimental group (n=13) vs Control group (n=8)
Time Frame: 1 year
|
Leger Test:or multi-stage fitness test, requires running back and forth between two markers placed exactly 20 meters (65.6 feet) apart.
The pace is set by audio beeps, with speeds increasing every minute (level), typically starting at 8.5 km/h and increasing by 0.5 km/h each level
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C1LN001
- 100008-2024-AIFFRA (Other Identifier: univeristy of Genova, university research funds)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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