Metabolic DiseaseBEETITNCT03545009
Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
A study testing Sodium Nitrate, Beetroot Juice no Nitrate and Beetroot Juice in people with Metabolic Disease and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Obesity, Exercise
- What is being tested?
- Sodium Nitrate, Beetroot Juice no Nitrate and Beetroot Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 30 Aug 2020
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 30 kg/m2
- Able to perform exercise testing on a cycle ergometer
Who cannot join
- Currently taking medications know to affect cardiovascular or respiratory function
- Currently supplementing with an antioxidant compound
- Current smoker
- Currently taking antibiotics
- Not willing to abstain from mouthwash use
- Currently participating in regular physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.
- Conditions
- Metabolic Disease, Obesity, Exercise
- Being tested
- Sodium Nitrate, Beetroot Juice no Nitrate, Beetroot Juice
- Medical subject headings
- Metabolic Diseases, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitrateDietary supplement
70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm
Beetroot Juice no NitrateDietary supplement
70ml Concentrated Beetroot Juice with nitrate removed
Beetroot JuiceDietary supplement
70ml Concentrated Beetroot Juice
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Juice | Experimental | Not described Receives: Dietary Supplement: Beetroot Juice |
| Beetroot Juice no Nitrate | Active comparator | Not described Receives: Dietary Supplement: Beetroot Juice no Nitrate |
| Sodium Nitrate | Active comparator | Not described Receives: Dietary Supplement: Sodium Nitrate |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Exhaustion
Measured: A Time to Exhaustion Test will be conducted on each participant a total of four times throughout their participation in the study. This will take place approximately 2.5 hours post ingestion of the dietary supplement they are randomized to at each visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start10 Aug 2018
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon Fisher, University of Alabama at Birmingham
- Investigators
- Gordon Fisher, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545009
- Sponsor's protocol ID
- 300001210
- Acronym
- BEETIT
- Status last verified
- Sep 2021
- First submitted
- 22 May 2018
- Last updated
- 22 Sep 2021
- 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 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
- ClinicalTrials.gov ID
- NCT03545009
- Acronym / sponsor ID
- BEETIT / 300001210
- Conditions
- Metabolic Disease, Obesity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 4 Jun 2018 (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 purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beetroot Juice | Experimental | Dietary Supplement: Beetroot Juice |
| Beetroot Juice no Nitrate | Active comparator | Dietary Supplement: Beetroot Juice no Nitrate |
| Sodium Nitrate | Active comparator | Dietary Supplement: Sodium Nitrate |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI ≥ 30 kg/m2
- Able to perform exercise testing on a cycle ergometer
Key exclusion criteria (6 listed)
- Currently taking medications know to affect cardiovascular or respiratory function
- Currently supplementing with an antioxidant compound
- Current smoker
- Currently taking antibiotics
- Not willing to abstain from mouthwash use
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 |
|---|---|---|
| Sodium Nitrate70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm | Dietary supplement | Sodium Nitrate |
| Beetroot Juice no Nitrate70ml Concentrated Beetroot Juice with nitrate removed | Dietary supplement | Beetroot Juice no Nitrate |
| Beetroot Juice70ml Concentrated Beetroot Juice | Dietary supplement | Beetroot Juice |
Primary outcome
Time to Exhaustion
Time frame: A Time to Exhaustion Test will be conducted on each participant a total of four times throughout their participation in the study. This will take place approximately 2.5 hours post ingestion of the dietary supplement they are randomized to at each visit.
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 22 Sep 2021.
- 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.
Gordon Fisher, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Nitrate, Beetroot Juice no Nitrate and Beetroot Juice in people with Metabolic Disease and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
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 2 inclusion and 6 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 22 Sep 2021. 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 United States. 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?
Time to Exhaustion (time frame: A Time to Exhaustion Test will be conducted on each participant a total of four times throughout their participation in the study. This will take place approximately 2.5 hours post ingestion of the dietary supplement they are randomized to at each visit.). 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 22 Sep 2021.