HealthyNCT05777642
Oxygen Nanobubble Drink Impact on Exercise in Elite Athletes
A study testing Oxygen Nanobubble in people with Healthy, run by University of Oxford.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxygen Nanobubble
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Oxygen Nanobubble, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen NanobubbleDietary supplement
This contains oxygenated nanobubbles made from lecithin and natural flavourings (Liquorice, glycerol, and citric acid)
PlaceboDietary supplement
This does not contain nanobubbles and is made from natural flavourings (Liquorice, glycerol, and citric acid)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Oxygen Nanobubble; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
2000m Row Time
Time taken to complete 2000m Row
Measured: 7 days
Secondary outcomes (5)
Heart Rate
Changes in the Heartrate before and after the 2000m Row with the oxygen nanobubbles drink compared with the placebo drink
Measured: 7 days
Peripheral Oxygen Saturation (SpO2)
Changes in the Oxygen Saturation (SpO2) before and after the 2000m Row with the oxygen nanobubbles drink compared with the placebo drink.
The oxygen saturation (SpO2) will be measured by a pulse oximeter on a scale of 0-100%.
Measured: 7 days
Rate of Perceived Exertion
Changes in the Rate of Perceived Exertion before and after the 2000m Row with the oxygen nanobubbles drink compared with the placebo drink.
This uses the Borg scale from 6-20, where 6 indicates light exertion, and 20 indicates maximal exertion
Measured: 7 days
Blood Lactate
Changes in the blood lactate before and after the 2000m Row with the oxygen nanobubbles drink compared with the placebo drink.
Measured: 7 days
Blood Glucose
Changes in the blood glucose before and after the 2000m Row with the oxygen nanobubbles drink compared with the placebo drink.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start20 Apr 2023 (estimated)
- Primary completion18 May 2024 (estimated)
- Study completion18 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashok Handa, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777642
- Sponsor's protocol ID
- R83003/RE001
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05777642
- Acronym / sponsor ID
- R83003/RE001
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 18 May 2024 (estimated)
- Study completion
- 18 Jun 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen Nanobubble First | Experimental | Dietary Supplement: Oxygen Nanobubble, Dietary Supplement: PlaceboIn 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. |
| Placebo First | Placebo comparator | Dietary Supplement: Oxygen Nanobubble, Dietary Supplement: PlaceboIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen NanobubbleThis contains oxygenated nanobubbles made from lecithin and natural flavourings (Liquorice, glycerol, and citric acid) | Dietary supplement | Oxygen Nanobubble First, Placebo First |
| PlaceboThis does not contain nanobubbles and is made from natural flavourings (Liquorice, glycerol, and citric acid) | Dietary supplement | Oxygen Nanobubble First, Placebo First |
Primary outcome
2000m Row Time
Time frame: 7 days
Time taken to complete 2000m Row
5 secondary outcomes
Heart Rate
Time frame: 7 days
Peripheral Oxygen Saturation (SpO2)
Time frame: 7 days
Rate of Perceived Exertion
Time frame: 7 days
Blood Lactate
Time frame: 7 days
Blood Glucose
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Handa principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Nanobubble in people with Healthy, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihir Sheth (01865617683, mihir.sheth@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2000m Row Time (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.