HypertensionBRJ_TMAONCT05004935
The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration
A study testing beetroot juice and nitrate in people with Hypertension, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration. A secondary aims: exploring the effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status, and measurement of changes in the skin… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- beetroot juice and nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 15 Dec 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Electromyography Activation Trunk Muscles and the Effect of Beetroot Juice Intake on the Results in Strength Exercises: Lateral Medicine Ball Throw and Sled Pushing
The primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration.
A secondary aims: exploring the effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status, and measurement of changes in the skin nicotinamide-adenine dinucleotide reduced form (NADH) content during transient ischemia and reperfusion.
Read the detailed description
In a random order subjects will consume beetroot juice (140ml), or equimolar nitrates (NaNO3). Antecubital vein blood samples will be taken at the beginning, and every hour for 4 hours following consumption.
Plasma trimethylamine N-oxide, total antioxidant status, and nitrite/nitrate concentrations will be determined.
Using Flow Mediated Skin Fluorescence skin NADH content determined during controlled ischemia triggered by total occlusion of the brachial artery by the brachial blood pressure cuff and during reperfusion after deflation of the blood pressure cuff 2 and 4 hours following consumption.
- Conditions
- Hypertension
- Being tested
- beetroot juice, nitrate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beetroot juiceDietary supplement
Also called 140 ml of Beet It juice
single intake of beetroot juice containing 800mg nitrates
nitrateOther
Also called NaNO3
single intake of 800mg nitrates
| Study group | Role | What they receive |
|---|---|---|
| beetroot juice | Experimental | single intake of beetroot juice containing 800mg nitrates Receives: Dietary Supplement: beetroot juice |
| nitrates | Active comparator | single intake of 800mg nitrates (NaNO3) Receives: Other: nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration
Determination of plasma trimethylamine N-oxide concentration following the beetroot juice consumption using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method.
Measured: 4 hours
Secondary outcomes (1)
The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status
Determination of plasma total antioxidant status following the beetroot juice consumption using commercially available kit.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Olek, Poznan University of Physical Education
- Investigators
- Robert A Olek, PhD, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004935
- Sponsor's protocol ID
- RMPN2021/JJ
- Acronym
- BRJ_TMAO
- Status last verified
- Sep 2023
- First submitted
- 5 Aug 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jurga J, Samborowska E, Zielinski J, Olek RA. Effects of Acute Beetroot Juice and Sodium Nitrate on Selected Blood Metabolites and Response to Transient Ischemia: A Crossover Randomized Clinical Trial. J Nutr. 2024 Feb;154(2):491-497. doi: 10.1016/j.tjnut.2023.12.018. Epub 2023 Dec 16.
PubMed 38110180
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Electromyography Activation Trunk Muscles and the Effect of Beetroot Juice Intake on the Results in Strength Exercises: Lateral Medicine Ball Throw and Sled Pushing
- ClinicalTrials.gov ID
- NCT05004935
- Acronym / sponsor ID
- BRJ_TMAO / RMPN2021/JJ
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Aug 2021 (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 primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration.
A secondary aims: exploring the effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status, and measurement of changes in the skin nicotinamide-adenine dinucleotide reduced form (NADH) content during transient ischemia and reperfusion.
Detailed description
In a random order subjects will consume beetroot juice (140ml), or equimolar nitrates (NaNO3). Antecubital vein blood samples will be taken at the beginning, and every hour for 4 hours following consumption.
Plasma trimethylamine N-oxide, total antioxidant status, and nitrite/nitrate concentrations will be determined.
Using Flow Mediated Skin Fluorescence skin NADH content determined during controlled ischemia triggered by total occlusion of the brachial artery by the brachial blood pressure cuff and during reperfusion after deflation of the blood pressure cuff 2 and 4 hours following consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beetroot juice | Experimental | Dietary Supplement: beetroot juicesingle intake of beetroot juice containing 800mg nitrates |
| nitrates | Active comparator | Other: nitratesingle intake of 800mg nitrates (NaNO3) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| beetroot juiceAlso: 140 ml of Beet It juicesingle intake of beetroot juice containing 800mg nitrates | Dietary supplement | beetroot juice |
| nitrateAlso: NaNO3single intake of 800mg nitrates | Other | nitrates |
Primary outcome
The effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration
Time frame: 4 hours
Determination of plasma trimethylamine N-oxide concentration following the beetroot juice consumption using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method.
1 secondary outcome
The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 38110180Jurga J, Samborowska E, Zielinski J, Olek RA. Effects of Acute Beetroot Juice and Sodium Nitrate on Selected Blood Metabolites and Response to Transient Ischemia: A Crossover Randomized Clinical Trial. J Nutr. 2024 Feb;154(2):491-497. doi: 10.1016/j.tjnut.2023.12.018. Epub 2023 Dec 16.
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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.
Robert A Olek, PhD principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beetroot juice and nitrate in people with Hypertension, run by Poznan University of Physical Education at 1 site in Poland.
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 1 inclusion and 0 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 15 Nov 2023. 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 Poland. 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?
Results are not available in the source record.
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?
The effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004935, which also lists 1 linked publication.
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 15 Nov 2023.