- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
AQ
-
Avezzano, AQ, Italien, 67051
- Stadio del Rugby
-
-
Genova
-
Genova, Genova, Italien, 16132
- University of Genova
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Inclusion criteria were age ≥18
Exclusion Criteria:
- NA
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: • Control group (CG): n = 15, which continued standard training without supplementation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- C1LN001
- 100008-2024-AIFFRA (Anden identifikator: univeristy of Genova, university research funds)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .