Uric Acid Metabolism, Endothelial Function and Oxidative Stress in Vegans and Omnivores.

June 29, 2020 updated by: Erasme University Hospital

Differential Analysis of Uric Acid Metabolism, Endothelial Function, Oxidative Stress and Cardiovascular Parameters in Vegans and Omnivores.

50 vegans and 50 omnivores will be recruited at the Erasme Hospital, Brussels.

Hypothesis

  • Relative induced-hyperuricemia by the vegan diet is not associated with impaired endothelial function if vitamin B12 and folic acid levels are normal.
  • Quantification of xanthine oxidoreductase (XOR) isoforms varies according to the diet. Omnivores present more xanthine oxidase (XO) than vegans in which the xanthine dehydrogenase (XD) isoform is more prevalent.
  • The vegan group has more favorable oxidant, metabolic and inflammatory profiles than the omnivore group.

Study Overview

Status

Completed

Detailed Description

Non-meat eaters rise widely worldwide. This choice answers ideological, ecological or health concerns. Several vegetarian diets exist and the vegan diet is the most restricted one as it excludes all animal products, eggs and dairy.

Beside benefits on health and particularly on the cardiovascular system (blood pressure, weight, lipid profile), some authors described less favorable lipid and oxidative profiles and others described an impairment in endothelial function markers in 'vegans'. These effects were attributed to low vitamin B12 and folate levels and high homocystein levels. However, vitamin B12 supplementation improved these parameters. Epidemiological studies also showed that 'vegans' disclose higher uric acid levels than other vegetarians or omnivores. Uric acid acts as an antioxidant in the plasma but can be deleterious for vascular cells leading to endothelial dysfunction. The main enzyme involved in uric acid metabolism is xanthine oxidoreductase which exists under two interconvertible isoforms. Xanthine dehydrogenase is the main form and uses nicotinamide adenine dinucleotide (NAD+) as electron acceptor and does not produce reactive oxygen species (ROS). In contrast, the other isoform xanthine oxidase uses oxygen as an electron acceptor and produces reactive oxygen species (ROS). The investigators wish to test the hypothesis that it is not uric acid per se, but which isoform of xanthine oxidoreductase which alters endothelial function. This is why the investigators wish to determine if regular 'vegans' (with normal vitamin B12 and folate levels) disclose increased uric acid levels in the presence of a reduced inflammation, oxidative stress and improved endothelial function, as compared to matched 'omnivores'.

50 vegans and 50 omnivores will be recruited at the Erasme Hospital, Brussels.

Hypothesis

  • Relative induced-hyperuricemia by the vegan diet is not associated with impaired endothelial function if vitamin B12 and folic acid levels are normal.
  • Quantification of oxidoreductase (XOR) isoforms varies according to the diet. Omnivores present more xanthine oxidase (XO) than vegans in which the xanthine dehydrogenase (XD) isoform is more prevalent.
  • The vegan group has more favorable oxidant, metabolic and inflammatory profiles than the omnivore group.

Study Type

Observational

Enrollment (Actual)

103

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

    • Belgique
      • Brussels, Belgique, Belgium, 1070
        • Erasme hospital

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 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited upon invitation on social network mainly.

Description

Inclusion Criteria:

  • Vegan or omnivore diet for at least one year (matched for age, gender, BMI, socio-economic status and weight)
  • Healthy

Exclusion Criteria:

  • Smoking
  • Chronic treatment
  • No allowed drugs taking
  • Excessive alcohol consumption

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Omnivore
Analysis of endothelial function, oxidative stress
Vegan
Analysis of endothelial function, oxidative stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the perfusion of the microcirculation of the skin
Time Frame: 2 hours

Endothelial function assessment will be performed through analyse of the perfusion of the microcirculation of the skin in the forearm will be assessed by means of a laser Doppler imager and iontophoresis of acetylcholine and sodium nipride. Heating-induced hyperemia will be assessed after iontophoresis of inhibitor of NO synthase and saline. Units are perfusion unit.

Iontophoresis is a non-invasive tool which permits to infuse molecules in the first micrometers of the skin. The used molecules are vasodilative, saline or NO synthase inhibitor.

2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Uric acid
Time Frame: 2 hours
Uric acid (mg/dL or SI)
2 hours
Concentration of xanthine oxidase and xanthine dehydrogenase in blood
Time Frame: 2 hours
western blot
2 hours
Measure of hemoglobin
Time Frame: 2 hours
g/l
2 hours
Measure of white blood cells, red blood cells and platelets
Time Frame: 2 hours
cells/µl of blood
2 hours
Measure of urea, creatinine, bilirubin, albumine, prealbumin, LDL, HDL, lp(a), total cholesterol, triglyceride, apolipoprotein A and B
Time Frame: 2 hours
mg/dl
2 hours
Measure of glycemia, vitamine and iron status (B3, B6, B12, C, D, E, B9, Zn, Cu, Selenium, iron, ferritin), c-reactive protein, homocystein
Time Frame: 2 hours
mg/dl
2 hours
Measure of sodium, potassium, chlore, phosphor, calcium, magnesium, HbA1c, omega 3 et 6
Time Frame: 2 hours
mmol/l
2 hours
Measure of glomerular filtration rate
Time Frame: 2 hours
ml/min
2 hours
Measure of gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatin phosphokinase, insulin, TSH
Time Frame: 2 hours
u/l
2 hours
Measure of allantoin, homocitrulline/lysine, chloro-tyrosine/tyrosine, Il-8, myeloperoxidase
Time Frame: 2 hours
Mass spectrometry and Elisa Kits
2 hours
Measure of renin, aldosterone, angiotensin 2, angiotensin converting enzyme
Time Frame: 2 hours
2 hours
Measure of main proteomes and metabolomes in cells incubated with sera from participants
Time Frame: 2 hours
Sera will be used for cell cultures. Theses cells will be lysed and used to analyse and compare the different proteomes / metabolomes according to the groups. We will be able to understand which protein groups are reduced or enhanced according to the diet.
2 hours
Measure of blood pressure
Time Frame: 2 hours
Systolic and diastolic blood pressure
2 hours
Measure of baroreflex sensitivity
Time Frame: 2 hours
finometer
2 hours
Measure of heart rate
Time Frame: 2 hours
finometer
2 hours
Measure of augmentation index
Time Frame: 2 hours
Assessment of the arterial stiffness
2 hours
Measure of pulse wave velocity
Time Frame: 2 hours
Assessment of the arterial stiffness
2 hours
Diet questionary
Time Frame: 2 hours
Diet History Questionnaire third version provides estimation of one year consumption of proteins, carbohydrates, lipids, micronutrient and vitamines
2 hours

Collaborators and Investigators

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

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)

March 10, 2019

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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