Oxygen Nanobubble Drink Impact on Exercise in Elite Athletes

NCT05777642 | Unknown

• 1 other identifier: R83003/RE001
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 2000m Row Time

  Time taken to complete 2000m Row

  7 days

Secondary Outcomes (5)

• Heart Rate

  7 days

• Peripheral Oxygen Saturation (SpO2)

  7 days

• Rate of Perceived Exertion

  7 days

• Blood Lactate

  7 days

• Blood Glucose

  7 days

Study Arms (2)

Oxygen Nanobubble First

EXPERIMENTAL

In this arm, the oxygen nanobubbles drink will be provided as the first drink. The oxygen nanobubbles mixture will be mixed with water and oxygenated and provided as a one-time 200ml drink 10 minutes before the start of the 2000m row. The placebo will be provided as the second drink, 2-4 days after the first drink. The placebo mixture will be mixed with water and oxygenated and provided as a one-time 200ml drink 10 minutes before the start of the 2000m row.

Dietary Supplement: Oxygen Nanobubble; Dietary Supplement: Placebo

Placebo First

PLACEBO COMPARATOR

In this arm, the placebo drink will be provided as the first drink. The placebo mixture will be mixed with water and oxygenated and provided as a one-time 200ml drink 10 minutes before the start of the 2000m row. The oxygen nanobubbles will be provided as the second drink, 2-4 days after the first drink. The oxygen nanobubbles mixture will be mixed with water and oxygenated and provided as a one-time 200ml drink 10 minutes before the start of the 2000m row.

Dietary Supplement: Oxygen Nanobubble; Dietary Supplement: Placebo

Interventions

Oxygen Nanobubble DIETARY_SUPPLEMENT

This contains oxygenated nanobubbles made from lecithin and natural flavourings (Liquorice, glycerol, and citric acid)

Oxygen Nanobubble First; Placebo First

Placebo DIETARY_SUPPLEMENT

This does not contain nanobubbles and is made from natural flavourings (Liquorice, glycerol, and citric acid)

Oxygen Nanobubble First; Placebo First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the research
• Participant is 18+ years of age
• Not currently taking any medications (except the contraceptive pill)
• The participant must be a competitive rower, with an estimated 2000m time of ≤6:30 minutes for males, and ≤ 8 minutes for females.
• The participant agrees to abstain from tobacco and nicotine products 24 hours before each visit.
• The participant agrees to abstain from alcohol 24 hours before each visit.
• The participant is, in the opinion of the investigator, healthy on the basis of a self-reported medical history, vital signs.
• The participant has no active disease process that could interfere with endpoints.
• Available for the duration of the study.
• The participant is not taking regular medications (including NSAIDs such as ibuprofen) that could interfere with endpoints measured and/or influence gastrointestinal permeability and led to gastrointestinal symptoms.
• The participant has not taken dietary/nutritional supplements in the preceding 2 weeks.
• The participant is not following a weight reducing diet.
• The participant is willing not to undertake strenuous or unaccustomed physical exercise for at least 24 hours prior to screening and study visits.

You may not qualify if:

• Participants with a history of smoking in the previous 30 days
• Participants that are allergic or intolerant towards: Liquorice, Lecithin derived from soya or sunflower, Citric acid, Glycerol
• Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or haematological disease or abnormality, as determined by the self-reported health questionnaire.
• History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding study visit 1.
• Currently participating in another study with an investigational or non-investigational drug or device, or has participated in another clinical study within the 2 months preceding study visit 1 (based on participant's self report).
• Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
• Participant is pregnant and/or breastfeeding

Sponsors & Collaborators

• University of Oxford: lead

Study Officials

• Ashok Handa

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihir Sheth

CONTACT

01865617683; mihir.sheth@nds.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 21, 2023
• Study Start: April 20, 2023
• Primary Completion: May 18, 2024
• Study Completion: June 18, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share