Back to resultsThe Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration (BRJ_TMAO)
Primary Purpose
Hypertension
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
beetroot juice
nitrate
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
Sites / Locations
- Akademia Wychowania Fizycznego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
beetroot juice
nitrates
Arm Description
single intake of beetroot juice containing 800mg nitrates
single intake of 800mg nitrates (NaNO3)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05004935
First Posted
August 5, 2021
Last Updated
September 12, 2023
Sponsor
Poznan University of Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT05004935
Brief Title
The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration
Acronym
BRJ_TMAO
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
beetroot juice
Arm Type
Experimental
Arm Description
single intake of beetroot juice containing 800mg nitrates
Arm Title
nitrates
Arm Type
Active Comparator
Arm Description
single intake of 800mg nitrates (NaNO3)
Intervention Type
Dietary Supplement
Intervention Name(s)
beetroot juice
Other Intervention Name(s)
140 ml of Beet It juice
Intervention Description
single intake of beetroot juice containing 800mg nitrates
Intervention Type
Other
Intervention Name(s)
nitrate
Other Intervention Name(s)
NaNO3
Intervention Description
single intake of 800mg nitrates
Primary Outcome Measure Information:
Title
The effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration
Description
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 Outcome Measure Information:
Title
The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status
Description
Determination of plasma total antioxidant status following the beetroot juice consumption using commercially available kit.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Olek, PhD
Organizational Affiliation
Poznan University of Physical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akademia Wychowania Fizycznego
City
Poznan
ZIP/Postal Code
61-871
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration
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