- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05004935
The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration (BRJ_TMAO)
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Poznan, Poland, 61-871
- Akademia Wychowania Fizycznego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
Study Plan
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:
|
|
Active Comparator: nitrates
single intake of 800mg nitrates (NaNO3)
|
single intake of 800mg nitrates
Other Names:
|
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
Investigators
- Principal Investigator: Robert A Olek, PhD, Poznań University of Physical Education
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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