Blood Plasma NitriteNCT05452421
Nitrate and Power Output After Two Beetroot Juice Drinks
A study testing Isotonic carbohydrate beetroot juice drink and Beetroot juice drink in people with Blood Plasma Nitrite, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Plasma Nitrite
- What is being tested?
- Isotonic carbohydrate beetroot juice drink and Beetroot juice drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2022to 10 Oct 2022
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21-35 years.
- Healthy and injury-free: defined as no positive (Yes) answers to the Physical Activity Readiness Questionnaire (PAR-Q+) and not reporting any other health issues that may be affected by exercise.
- Blood pressure: <130/90 mmHg.
- Physically active: Engaging in a minimum of 150 minutes of moderate-intensity exercise or 75 minutes of vigorous-intensity physical activity each week determined via self-report Global Physical Activity Questionnaire (GPAQ).
- Body mass index (BMI): 18.5-25.0 kg/m2.
- Non-smoker.
Who cannot join
- Any allergies to beetroot or isotonic drink.
- Asthma.
- Any report of personal health issues that may compromise the individual's ability to undertake exercise safely.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University
Singapore, 637616
About this study
Official title: Plasma and Salivary Nitrate/Nitrite Responses and Power Output Compared After Two Beetroot Juice Drinks
The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Optimal timing of drink consumption in relation to exercise can then be prescribed in relation to nitrite appearance in the blood. A randomised controlled trial with participants completing two conditions: (i) BR and (ii) ISO-CB. On each condition participants will consume During each trial, participants will ingest 2 x 285ml of beverage 3 hours prior to performing two jump tests follow by a Wingate test. Salivary NO content will be measured at the start of the morning, 1 hour, 2 hours, 3 hours after consumption of beverage and at the end of the exercise.
Read the detailed description
- The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Optimal timing of drink consumption in relation to exercise can then be prescribed in relation to nitrite appearance in the blood.
- A secondary aim of this study is to evaluate the association between blood plasma nitrite concentration and saliva nitrite concentration after ingestion of the two drinks to determine whether blood plasma analysis can be fully or partially substituted with a salivary nitrite test.
- A final aim of this study is to investigate the ergogenic effects of ISO-CB compared with BR during a single 30 second cycling sprint bout (Wingate test) and two jumping tests.
A randomised controlled trial recruiting 24 healthy male and female participants. Each participant will complete two conditions: (i) BR and (ii) ISO-CB. On each condition participants will consume During each trial, participants will ingest 2 x 285ml of beverage 3 hours prior to performing two jump tests follow by a Wingate test. In the next trial, participants will undergo the same procedures, but ingest the beverage that they did not take the previous round. The study will be double-blinded study. Blood samples will be taken before supplementation, 2 hours and 3 hours after consuming the beverage. Salivary NO content will be measured at the start of the morning, 1 hour, 2 hours, 3 hours after consumption of beverage and at the end of the exercise. For each trial, participants will also fill out a sensory evaluation form in relation to the drink consumed. It is hypothesized that blood plasma nitrite and saliva nitrite appearance will be earlier with ISO-CB and that participants will have improved peak and mean power when ISO-CB is consumed compared with BR.
- Conditions
- Blood Plasma Nitrite
- Being tested
- Isotonic carbohydrate beetroot juice drink, Beetroot juice drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic carbohydrate beetroot juice drinkDietary supplement
Also called ISO-CB
An isotonic carbohydrate beetroot juice drink containing 141 mg nitrate per 100 ml (12.9 mmol). Total of 570 ml serving in two doses of 285 ml over one morning. Contains 6.2 g carbohydrate per 100 ml. Osmolality 304-310 mOsm/kg.
Beetroot juice drinkDietary supplement
Also called BR
A beetroot juice drink containing 141 mg nitrate per 100 ml (12.9 mmol). Total of 570 ml serving in two doses of 285 ml over one morning. Contains 6.1 g carbohydrate per 100 ml. Osmolality 390-410 mOsm/kg.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Isotonic carbohydrate beetroot juice drink Receives: Dietary Supplement: Isotonic carbohydrate beetroot juice drink; Dietary Supplement: Beetroot juice drink |
| Group B | Experimental | Beetroot juice drink Receives: Dietary Supplement: Isotonic carbohydrate beetroot juice drink; Dietary Supplement: Beetroot juice drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood plasma nitrite
Peak concentration of blood plasma nitrite
Measured: 3 hours
Secondary outcomes (3)
Salivary nitrite
Salivary nitrite concentration
Measured: 3 hours
Power output
Peak and mean power output
Measured: 30 seconds
Jump height and distance
Jump height and distance
Measured: Two jumps averaged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jul 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Plasma NitriteStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Burns, Nanyang Technological University
- Investigators
- Stephen Burns, PhD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452421
- Sponsor's protocol ID
- IRB-2022-149
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma and Salivary Nitrate/Nitrite Responses and Power Output Compared After Two Beetroot Juice Drinks
- ClinicalTrials.gov ID
- NCT05452421
- Acronym / sponsor ID
- IRB-2022-149
- Conditions
- Blood Plasma Nitrite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 11 Jul 2022 (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.
The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Optimal timing of drink consumption in relation to exercise can then be prescribed in relation to nitrite appearance in the blood. A randomised controlled trial with participants completing two conditions: (i) BR and (ii) ISO-CB. On each condition participants will consume During each trial, participants will ingest 2 x 285ml of beverage 3 hours prior to performing two jump tests follow by a Wingate test. Salivary NO content will be measured at the start of the morning, 1 hour, 2 hours, 3 hours after consumption of beverage and at the end of the exercise.
Detailed description
- The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Optimal timing of drink consumption in relation to exercise can then be prescribed in relation to nitrite appearance in the blood.
- A secondary aim of this study is to evaluate the association between blood plasma nitrite concentration and saliva nitrite concentration after ingestion of the two drinks to determine whether blood plasma analysis can be fully or partially substituted with a salivary nitrite test.
- A final aim of this study is to investigate the ergogenic effects of ISO-CB compared with BR during a single 30 second cycling sprint bout (Wingate test) and two jumping tests.
A randomised controlled trial recruiting 24 healthy male and female participants. Each participant will complete two conditions: (i) BR and (ii) ISO-CB. On each condition participants will consume During each trial, participants will ingest 2 x 285ml of beverage 3 hours prior to performing two jump tests follow by a Wingate test. In the next trial, participants will undergo the same procedures, but ingest the beverage that they did not take the previous round. The study will be double-blinded study. Blood samples will be taken before supplementation, 2 hours and 3 hours after consuming the beverage. Salivary NO content will be measured at the start of the morning, 1 hour, 2 hours, 3 hours after consumption of beverage and at the end of the exercise. For each trial, participants will also fill out a sensory evaluation form in relation to the drink consumed. It is hypothesized that blood plasma nitrite and saliva nitrite appearance will be earlier with ISO-CB and that participants will have improved peak and mean power when ISO-CB is consumed compared with BR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Isotonic carbohydrate beetroot juice drink, Dietary Supplement: Beetroot juice drinkIsotonic carbohydrate beetroot juice drink |
| Group B | Experimental | Dietary Supplement: Isotonic carbohydrate beetroot juice drink, Dietary Supplement: Beetroot juice drinkBeetroot juice drink |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 21-35 years.
- Healthy and injury-free: defined as no positive (Yes) answers to the Physical Activity Readiness Questionnaire (PAR-Q+) and not reporting any other health issues that may be affected by exercise.
- Blood pressure: <130/90 mmHg.
- Physically active: Engaging in a minimum of 150 minutes of moderate-intensity exercise or 75 minutes of vigorous-intensity physical activity each week determined via self-report Global Physical Activity Questionnaire (GPAQ).
- Body mass index (BMI): 18.5-25.0 kg/m2.
Key exclusion criteria (3 listed)
- Any allergies to beetroot or isotonic drink.
- Asthma.
- Any report of personal health issues that may compromise the individual's ability to undertake exercise safely.
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 |
|---|---|---|
| Isotonic carbohydrate beetroot juice drinkAlso: ISO-CBAn isotonic carbohydrate beetroot juice drink containing 141 mg nitrate per 100 ml (12.9 mmol). Total of 570 ml serving in two doses of 285 ml over one morning. Contains 6.2 g carbohydrate per 100 ml. Osmolality 304-310 mOsm/kg. | Dietary supplement | Group A, Group B |
| Beetroot juice drinkAlso: BRA beetroot juice drink containing 141 mg nitrate per 100 ml (12.9 mmol). Total of 570 ml serving in two doses of 285 ml over one morning. Contains 6.1 g carbohydrate per 100 ml. Osmolality 390-410 mOsm/kg. | Dietary supplement | Group A, Group B |
Primary outcome
Blood plasma nitrite
Time frame: 3 hours
Peak concentration of blood plasma nitrite
3 secondary outcomes
Salivary nitrite
Time frame: 3 hours
Power output
Time frame: 30 seconds
Jump height and distance
Time frame: Two jumps averaged
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Blood Plasma Nitrite
Not yet recruiting
The Effects of Nitrate-Rich Mouthwash on Vascular Tone
Blood Pressure Regulation
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.
Stephen Burns, PhD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic carbohydrate beetroot juice drink and Beetroot juice drink in people with Blood Plasma Nitrite, run by Nanyang Technological University at 1 site in Singapore.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood plasma nitrite (time frame: 3 hours). 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 9 Apr 2024.