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

November 14, 2023 updated by: Robert Olek, Poznan University of Physical Education

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Poznan, Poland, 61-871
        • Akademia Wychowania Fizycznego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: beetroot juice
single intake of beetroot juice containing 800mg nitrates
single intake of beetroot juice containing 800mg nitrates
Other Names:
  • 140 ml of Beet It juice
Active Comparator: nitrates
single intake of 800mg nitrates (NaNO3)
single intake of 800mg nitrates
Other Names:
  • NaNO3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status
Time Frame: 4 hours
Determination of plasma total antioxidant status following the beetroot juice consumption using commercially available kit.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert A Olek, PhD, Poznań University of Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 15, 2023

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMPN2021/JJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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