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Enrolling by invitationNCT05004935BRJ_TMAOUpdated Nov 15, 2023

The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration

An interventional study of beetroot juice and nitrate in Hypertension, sponsored by Poznan University of Physical Education. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's planned enrollment of 20 is below the median of 90 across 4,996 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

healthy volunteers

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    beetroot juice

    single intake of beetroot juice containing 800mg nitrates

    Dietary Supplement: beetroot juice

  • Active comparator
    nitrates

    single intake of 800mg nitrates (NaNO3)

    Other: nitrate

Interventions

  • Dietary supplementbeetroot juice

    single intake of beetroot juice containing 800mg nitrates

    Also known as: 140 ml of Beet It juice

  • Othernitrate

    single intake of 800mg nitrates

    Also known as: NaNO3

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 4 hours

07

Study locations

1 site
  • Akademia Wychowania Fizycznego
    Poznan, 61-871, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05004935
Lead sponsor
Poznan University of Physical Education
Responsible party
Robert Olek (Principal Investigator, Poznan University of Physical Education) — Principal investigator
First posted
Aug 13, 2021
Start date
Sep 1, 2021
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 15, 2023 (estimated)
Last update
Nov 15, 2023

Study contacts

Robert A Olek, PhD
principal investigator · Poznan University of Physical Education

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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