NCT05004935

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

November 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

August 5, 2021

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

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.

    4 hours

Secondary Outcomes (1)

  • The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status

    4 hours

Study Arms (2)

beetroot juice

EXPERIMENTAL

single intake of beetroot juice containing 800mg nitrates

Dietary Supplement: beetroot juice

nitrates

ACTIVE COMPARATOR

single intake of 800mg nitrates (NaNO3)

Other: nitrate

Interventions

beetroot juiceDIETARY_SUPPLEMENT

single intake of beetroot juice containing 800mg nitrates

Also known as: 140 ml of Beet It juice
beetroot juice
nitrateOTHER

single intake of 800mg nitrates

Also known as: NaNO3
nitrates

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademia Wychowania Fizycznego

Poznan, 61-871, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Study Officials

  • Robert A Olek, PhD

    Poznan University of Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 13, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 15, 2023

Last Updated

November 15, 2023

Record last verified: 2023-09

Locations