Exercise PerformanceNCT05841407
Beetroot Supplementation and High Intensity Exercise
A study testing High nitrate isotonic drink and No nitrate isotonic drink in people with Exercise Performance, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
Ingested beetroot contains inorganic nitrate which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- High nitrate isotonic drink and No nitrate isotonic drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Mar 2023to 14 Mar 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21 - 40 years
- Healthy and injury-free (e.g., no cardiovascular disease, diabetes mellitus, orthopaedic impairment that interferes with moderate-to-vigorous 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.
- Recreational cyclist (Minimum 1 hour cycling per week)
- Body mass index: 18.5-25 kg/m2
- Non-smoker
- Asian ethnicity by self identification
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.
- Any recent Covid vaccination (within last 2 weeks).
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: The Effect of Isotonic Beetroot Supplementation on High-intensity Time-trial Performance
Ingested beetroot contains inorganic nitrate which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. Beetroot juice contain inorganic nitrate and consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism enhancing high-intensity exercise performance. Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two isotonic drinks with high in nitrate or with no nitrate.
Read the detailed description
Ingested beetroot contains inorganic nitrate (NO3-) which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. These functions mean that beetroot juice has become of strong interest in the field of exercise and is a recommended supplement for athletes to improve performance in recent consensus statements by the International Olympic Committee on dietary supplements. Importantly, the consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism, hence, enhancing high-intensity exercise performance . Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two drinks either high in nitrate or with no nitrate. Participants will ingest the two drinks in a randomised, crossover double-blind trial. One hour after drink ingestion they will undertake high intensity intermittent exercise for 30 minutes followed by a 10 km time trial on a cycle ergometer. Time trial will be compared between trials as the main outcome. It is hypothesised that the drink high in nitrate will lead to faster time trial completion.
- Conditions
- Exercise Performance
- Being tested
- High nitrate isotonic drink, No nitrate isotonic drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High nitrate isotonic drinkDietary supplement
High nitrate (12.9 mmol) drink with carbohydrate and minerals
No nitrate isotonic drinkDietary supplement
Carbohydrate and mineral isotonic drink
| Study group | Role | What they receive |
|---|---|---|
| High nitrate | Experimental | High nitrate isotonic drink Receives: Dietary Supplement: High nitrate isotonic drink |
| No nitrate | Active comparator | No nitrate isotonic drink Receives: Dietary Supplement: No nitrate isotonic drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 km cycling time trial (endurance) performance
Time trial
Measured: 1 hour after drink ingestion the time taken to complete 10 km on a stationary cycle ergometer will be assessed. Time to complete this is the primary outcome measure .
Secondary outcomes (2)
Salivary nitrate
Salivary nitrate concentration determined from strips
Measured: Four samples over 2 hours
Near infra-red spectroscopy (NIRS)
Tissue saturation index
Measured: During cycling ~1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start15 Mar 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT05841407
- Sponsor's protocol ID
- IRB-2022-880
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All published data will be placed into the Data Repository of Nanyang Technological University National Institute of Education for public access upon publication.
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
- The Effect of Isotonic Beetroot Supplementation on High-intensity Time-trial Performance
- ClinicalTrials.gov ID
- NCT05841407
- Acronym / sponsor ID
- IRB-2022-880
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 3 May 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.
Ingested beetroot contains inorganic nitrate which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. Beetroot juice contain inorganic nitrate and consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism enhancing high-intensity exercise performance. Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two isotonic drinks with high in nitrate or with no nitrate.
Detailed description
Ingested beetroot contains inorganic nitrate (NO3-) which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. These functions mean that beetroot juice has become of strong interest in the field of exercise and is a recommended supplement for athletes to improve performance in recent consensus statements by the International Olympic Committee on dietary supplements. Importantly, the consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism, hence, enhancing high-intensity exercise performance . Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two drinks either high in nitrate or with no nitrate. Participants will ingest the two drinks in a randomised, crossover double-blind trial. One hour after drink ingestion they will undertake high intensity intermittent exercise for 30 minutes followed by a 10 km time trial on a cycle ergometer. Time trial will be compared between trials as the main outcome. It is hypothesised that the drink high in nitrate will lead to faster time trial completion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High nitrate | Experimental | Dietary Supplement: High nitrate isotonic drinkHigh nitrate isotonic drink |
| No nitrate | Active comparator | Dietary Supplement: No nitrate isotonic drinkNo nitrate isotonic drink |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 21 - 40 years
- Healthy and injury-free (e.g., no cardiovascular disease, diabetes mellitus, orthopaedic impairment that interferes with moderate-to-vigorous 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.
- Recreational cyclist (Minimum 1 hour cycling per week)
Key exclusion criteria (4 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.
- Any recent Covid vaccination (within last 2 weeks).
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 |
|---|---|---|
| High nitrate isotonic drinkHigh nitrate (12.9 mmol) drink with carbohydrate and minerals | Dietary supplement | High nitrate |
| No nitrate isotonic drinkCarbohydrate and mineral isotonic drink | Dietary supplement | No nitrate |
Primary outcome
10 km cycling time trial (endurance) performance
Time frame: 1 hour after drink ingestion the time taken to complete 10 km on a stationary cycle ergometer will be assessed. Time to complete this is the primary outcome measure .
Time trial
2 secondary outcomes
Salivary nitrate
Time frame: Four samples over 2 hours
Near infra-red spectroscopy (NIRS)
Time frame: During cycling ~1 hour
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: Yes. All published data will be placed into the Data Repository of Nanyang Technological University National Institute of Education for public access upon publication.
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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.
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 High nitrate isotonic drink and No nitrate isotonic drink in people with Exercise Performance, 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 8 inclusion and 4 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?
10 km cycling time trial (endurance) performance (time frame: 1 hour after drink ingestion the time taken to complete 10 km on a stationary cycle ergometer will be assessed. Time to complete this is the primary outcome measure .). 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.