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Clinical Trials/NCT03849677
NCT03849677CompletedNot Applicable

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

Erasme University Hospital1 site in 1 country103 target enrollmentStarted: March 10, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
103
Locations
1
Primary Endpoint
Measure of the perfusion of the microcirculation of the skin

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Measure of augmentation index(2 hours)
  • Diet questionary(2 hours)
  • Concentration of xanthine oxidase and xanthine dehydrogenase in blood(2 hours)
  • Measure of sodium, potassium, chlore, phosphor, calcium, magnesium, HbA1c, omega 3 et 6(2 hours)
  • Measure of heart rate(2 hours)
  • Measure of pulse wave velocity(2 hours)
  • Concentration of Uric acid(2 hours)
  • Measure of glomerular filtration rate(2 hours)
  • Measure of allantoin, homocitrulline/lysine, chloro-tyrosine/tyrosine, Il-8, myeloperoxidase(2 hours)
  • Measure of main proteomes and metabolomes in cells incubated with sera from participants(2 hours)
  • Measure of hemoglobin(2 hours)
  • Measure of white blood cells, red blood cells and platelets(2 hours)
  • Measure of renin, aldosterone, angiotensin 2, angiotensin converting enzyme(2 hours)
  • Measure of blood pressure(2 hours)
  • Measure of urea, creatinine, bilirubin, albumine, prealbumin, LDL, HDL, lp(a), total cholesterol, triglyceride, apolipoprotein A and B(2 hours)
  • Measure of gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatin phosphokinase, insulin, TSH(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(2 hours)
  • Measure of baroreflex sensitivity(2 hours)

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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