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OpenTrials
Completed

NCT Number: NCT03849677

Uric Acid Metabolism, Endothelial Function and Oxidative Stress 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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme Hospital

Brussels, Belgique, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endothelial function and inflammation

Other

Analysis of endothelial function, oxidative stress

Primary outcomes

  1. 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

  1. Concentration of Uric acid

    Time frame: 2 hours

    Uric acid (mg/dL or SI)

  2. Concentration of xanthine oxidase and xanthine dehydrogenase in blood

    Time frame: 2 hours

    western blot

  3. Measure of hemoglobin

    Time frame: 2 hours

    g/l

  4. Measure of white blood cells, red blood cells and platelets

    Time frame: 2 hours

    cells/µl of blood

  5. Measure of urea, creatinine, bilirubin, albumine, prealbumin, LDL, HDL, lp(a), total cholesterol, triglyceride, apolipoprotein A and B

    Time frame: 2 hours

    mg/dl

  6. 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

  7. Measure of sodium, potassium, chlore, phosphor, calcium, magnesium, HbA1c, omega 3 et 6

    Time frame: 2 hours

    mmol/l

  8. Measure of glomerular filtration rate

    Time frame: 2 hours

    ml/min

  9. Measure of gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatin phosphokinase, insulin, TSH

    Time frame: 2 hours

    u/l

  10. Measure of allantoin, homocitrulline/lysine, chloro-tyrosine/tyrosine, Il-8, myeloperoxidase

    Time frame: 2 hours

    Mass spectrometry and Elisa Kits

  11. Measure of renin, aldosterone, angiotensin 2, angiotensin converting enzyme

    Time frame: 2 hours

  12. 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.

  13. Measure of blood pressure

    Time frame: 2 hours

    Systolic and diastolic blood pressure

  14. Measure of baroreflex sensitivity

    Time frame: 2 hours

    finometer

  15. Measure of heart rate

    Time frame: 2 hours

    finometer

  16. Measure of augmentation index

    Time frame: 2 hours

    Assessment of the arterial stiffness

  17. Measure of pulse wave velocity

    Time frame: 2 hours

    Assessment of the arterial stiffness

  18. Diet questionary

    Time frame: 2 hours

    Diet History Questionnaire third version provides estimation of one year consumption of proteins, carbohydrates, lipids, micronutrient and vitamines

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • Fonds Erasme
  • Fonds National de la Recherche Scientifique
  • Fonds pour la chirurgie cardiaque

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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