NCT05777642

Oxygen Nanobubble Drink Impact on Exercise in Elite Athletes

in Vivo Double-blind, Randomized, Placebo Controlled, Crossover Investigation of the Effect of Oral Administration of an Oxygen-nanobubble Drink on the Exercise Performance in Elite Athletes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Although the primary organ of gas exchange is the lung, it has been recognized for some time that other organs have a potential role in gas exchange. There is emerging evidence that the gastrointestinal tract may have the capacity to act as an organ of gas exchange. Several recent studies in both animals and humans have indicated that orally administered oxygenated nanobubbles is a safe intervention that can improve tissue oxygenation. Oxygen nanobubbles can reduce the hypoxia in tumours when injected, in conjunction with sonodynamic therapy. In mice, researchers have shown a reduction in tumour hypoxia and improved response to sonodynamic therapy occurs even when the oxygen nanobubbles are orally administered. This will be an in vivo randomized, double-blinded, cross-over, placebo-controlled study consisting of rowers. By measuring the time taken by participants to complete a 2000m row after consuming an Oxygen nanobubbles drink, and a placebo drink, the investigators will evaluate the efficacy of the nanobubbles on the exercising ability of the participant.

Detailed description

Although the primary organ of gas exchange is the lung, it has been recognized for some time that other organs have a potential role in gas exchange. There is emerging evidence that the gastrointestinal tract may have the capacity to act as an organ of gas exchange. Several animal studies have demonstrated that oxygen (delivered as a gas and within enriched water) is capable of diffusing through the mucosa of the colon, peritoneum and stomach resulting in elevated oxygen tension in the splanchnic circulation (hepatic portal vein, arterial and venous mixed blood) and increased blood flow (portal venous blood flow). One MRI study has demonstrated that orally administered oxygen-supersaturated water causes a significant increase in the luminal oxygen concentration in both the oral cavity and the stomach, despite a low amount of oxygen added to the overall oxygen balance of the body. Several recent studies in both animals and humans have indicated that orally administered oxygenated nanobubbles is a safe intervention that can improve tissue oxygenation. Oxygen nanobubbles can reduce the hypoxia in tumours when injected, in conjunction with sonodynamic therapy. In mice, researchers have shown a reduction in tumour hypoxia and improved response to sonodynamic therapy occurs even when the oxygen nanobubbles are orally administered. A study of male cyclists also showed that ingested oxygen nanobubbles led to an increased power output. This will be an in vivo randomized, double-blinded, cross-over, placebo-controlled study consisting of rowers. By measuring the time taken by participants to complete a 2000m row after consuming an Oxygen nanobubbles drink, and a placebo drink, the efficacy of the nanobubbles on the exercising ability of the participant will be evaluated. This will be supplemented with a comparison of a pre-intervention and post-intervention validated Rate of Perceived Exertion (RPE) breathlessness questionnaire and measurement of blood lactate and glucose, blood gases, respiratory gas exchange and heart rate.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oxygen Nanobubble	This contains oxygenated nanobubbles made from lecithin and natural flavourings (Liquorice, glycerol, and citric acid)
DIETARY_SUPPLEMENT	Placebo	This does not contain nanobubbles and is made from natural flavourings (Liquorice, glycerol, and citric acid)

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-05-18
• Completion: 2024-06-18
• First posted: 2023-03-21
• Last updated: 2023-03-21