- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849677
Uric Acid Metabolism, Endothelial Function and Oxidative Stress in Vegans and Omnivores.
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Belgique
-
Brussels, Belgique, Belgium, 1070
- Erasme hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 34735921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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