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

Sponsor
Erasme University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03849677
Collaborator
Fonds National de la Recherche Scientifique (Other), Fonds Erasme (Other), Fonds pour la chirurgie cardiaque (Other)
103
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15.4
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Endothelial function and inflammation

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
Actual Enrollment :
103 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Differential Analysis of Uric Acid Metabolism, Endothelial Function, Oxidative Stress and Cardiovascular Parameters in Vegans and Omnivores.
Actual Study Start Date :
Mar 10, 2019
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Jun 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Omnivore

Other: Endothelial function and inflammation
Analysis of endothelial function, oxidative stress

Vegan

Other: Endothelial function and inflammation
Analysis of endothelial function, oxidative stress

Outcome Measures

Primary Outcome Measures

  1. Measure of the perfusion of the microcirculation of the skin [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 Outcome Measures

  1. Concentration of Uric acid [2 hours]

    Uric acid (mg/dL or SI)

  2. Concentration of xanthine oxidase and xanthine dehydrogenase in blood [2 hours]

    western blot

  3. Measure of hemoglobin [2 hours]

    g/l

  4. Measure of white blood cells, red blood cells and platelets [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 [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 [2 hours]

    mg/dl

  7. Measure of sodium, potassium, chlore, phosphor, calcium, magnesium, HbA1c, omega 3 et 6 [2 hours]

    mmol/l

  8. Measure of glomerular filtration rate [2 hours]

    ml/min

  9. Measure of gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatin phosphokinase, insulin, TSH [2 hours]

    u/l

  10. Measure of allantoin, homocitrulline/lysine, chloro-tyrosine/tyrosine, Il-8, myeloperoxidase [2 hours]

    Mass spectrometry and Elisa Kits

  11. Measure of renin, aldosterone, angiotensin 2, angiotensin converting enzyme [2 hours]

  12. Measure of main proteomes and metabolomes in cells incubated with sera from participants [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 [2 hours]

    Systolic and diastolic blood pressure

  14. Measure of baroreflex sensitivity [2 hours]

    finometer

  15. Measure of heart rate [2 hours]

    finometer

  16. Measure of augmentation index [2 hours]

    Assessment of the arterial stiffness

  17. Measure of pulse wave velocity [2 hours]

    Assessment of the arterial stiffness

  18. Diet questionary [2 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
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)

  • Healthy

Exclusion Criteria:
  • Smoking

  • Chronic treatment

  • No allowed drugs taking

  • Excessive alcohol consumption

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erasme Hospital Brussels Belgique Belgium 1070

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT03849677
Other Study ID Numbers:
  • 34735921
First Posted:
Feb 21, 2019
Last Update Posted:
Jul 1, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erasme University Hospital

Study Results

No Results Posted as of Jul 1, 2020