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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05004935
Other study ID # RMPN2021/JJ
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date December 15, 2023

Study information

Verified date September 2023
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 nicotinamide-adenine dinucleotide reduced form (NADH) content during transient ischemia and reperfusion.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date December 15, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: healthy volunteers Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
beetroot juice
single intake of beetroot juice containing 800mg nitrates
Other:
nitrate
single intake of 800mg nitrates

Locations

Country Name City State
Poland Akademia Wychowania Fizycznego Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 4 hours
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