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.
1 other identifier
observational
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
March 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2020
CompletedJuly 1, 2020
June 1, 2020
1.1 years
February 6, 2019
June 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of the perfusion of the microcirculation of the skin
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 Outcomes (18)
Concentration of Uric acid
2 hours
Concentration of xanthine oxidase and xanthine dehydrogenase in blood
2 hours
Measure of hemoglobin
2 hours
Measure of white blood cells, red blood cells and platelets
2 hours
Measure of urea, creatinine, bilirubin, albumine, prealbumin, LDL, HDL, lp(a), total cholesterol, triglyceride, apolipoprotein A and B
2 hours
- +13 more secondary outcomes
Study Arms (2)
Omnivore
Vegan
Interventions
Analysis of endothelial function, oxidative stress
Eligibility Criteria
Participants will be recruited upon invitation on social network mainly.
You may qualify if:
- Vegan or omnivore diet for at least one year (matched for age, gender, BMI, socio-economic status and weight)
- Healthy
You may not qualify if:
- Smoking
- Chronic treatment
- No allowed drugs taking
- Excessive alcohol consumption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasme University Hospitallead
- Fonds National de la Recherche Scientifiquecollaborator
- Fonds Erasmecollaborator
- Fonds pour la chirurgie cardiaquecollaborator
Study Sites (1)
Erasme Hospital
Brussels, Belgique, 1070, Belgium
Biospecimen
Blood and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2019
First Posted
February 21, 2019
Study Start
March 10, 2019
Primary Completion
March 30, 2020
Study Completion
June 20, 2020
Last Updated
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share