Evaluation of the Effectiveness of Oral Ozonized Oil Supplementation in Elite Athletes

NCT07801924 | Completed

• 2 other identifiers: C1LN001100008-2024-AIFFRA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

Ozonized oil has anti-inflammatory and antioxidant properties, but its effects on athletic performance remain unclear. This study evaluated whether daily ozonized oil supplementation, combined with training, influences aerobic capacity, anaerobic power, maximal strength, and muscular endurance in elite rugby players over six months

Conditions

Recovery Methods; Strength Endurance; Muscular

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (2)

• 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)

  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)

  1 year

Study Arms (2)

Intervention group (IG): received daily ozonized oil supplementation

EXPERIMENTAL

The IG received the supplement of ozonized oil capsules (O3ZONE Sport ®). Dosage was standardized and adjusted according to body: * ≥100 kg: 6 capsules/day (3 morning, 3 evening) * \<100 kg: 4 capsules/day (2 morning, 2 evening) Adherence to the protocol was monitored weekly through self-report and supervision by team medical staff. 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

Dietary Supplement: Ozonized Oil

• Control group (CG): n = 15, which continued standard training without supplementation

NO INTERVENTION

Interventions

Ozonized Oil DIETARY_SUPPLEMENT

, 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.

Intervention group (IG): received daily ozonized oil supplementation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inclusion criteria were age ≥18
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

Study Sites (2)

Stadio del Rugby

Avezzano, AQ, 67051, Italy

Location

University of Genova

Genova, Genova, 16132, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Hygiene and Preventive Medicine School of Medicine, University of Genoa, Italy Director PhD School in Health Sciences and Cancer Prevention

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: September 3, 2026
• Study Start: September 9, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 18, 2025
• Last Updated: September 3, 2026

Record last verified: 2026-04

Locations

IT (2)