Influence of a vegan diet on immunological parameters related to rheumatoid arthritisin healthy volunteers – a randomised controlled trial
Not Applicable
- Conditions
- Inflammatory parameters, redox status and microbiome.Healthy volunteers
- Registration Number
- DRKS00011963
- Lead Sponsor
- niversitätsklinikum Freiburg, Institut für Umweltmedizin und Krankenhaushygiene, Uni-Zentrum Naturheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
healthy, 18 - 60 years old, body mass index (BMI) between 21 kg/m^2 and 30 kg/m^2
Exclusion Criteria
pregnany and breastfeeding; regular intake of medication (except contraceptives or iodide); pronounced allergies (medication needed during allergy season); momentarily adhering to a vegan or vegetarian diet; aversion towards a meat-rich or vegan diet; eating disorder (anamnestically); drug, alcohol (>20g / day) or nicotine abuse (daily use), participation in another study or blood donation during the last four weeks.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method metabolic function of B-cells, measured by the sialylation of anti-bodies; count of regulatory T-cells, measured by the concentration of FoxP3; serum-concentration of Interleukin 10; redox status of immune cells, measured by the intracellular ROS-concentration<br>In the beginning and in the end of the intervention we will take blood samples of all probands. Examination of the samples will be done in the end.
- Secondary Outcome Measures
Name Time Method - CCR6, a chemokine-receptor on TH-17 cells<br>- Neopterin, a marker of macrophages-activity<br>- I?Ba-degradation<br>- serum antibodies with galactosyl attachments<br>- serum free light chains (? and ?)<br>- serum IL-1, IL-6, IL-17, IL-20, IL-24, IL-27, TNF-a, TNF-ß, soluble IL-2 receptor<br>- arachidonic acid and eicosanoids in urine<br>- autophagy-markers (Atg8/LC3)<br>- lymphocytes differentiation<br>o activated T-cells: CD3+/HLA-DR+<br>o activated B-cells: CD19+/CD71+ (transferrin receptor)<br>o natural regulatory T-cells: CD3+/CD4+/CD25+/CD127 low<br>- differential blood count<br>- Vitamin D (25(OH)D), Vitamin B12 (transcobalamin II)<br>- Microbiological profile of gut flora<br>- epigenetical patterns in lymphocytes in peripheral blood specimens<br>- gene expression of cyclooxygenase in lymphocytes in peripheral blood<br>In the beginning and in the end of the intervention we will collect samples of urine, stool and blood of all probands. Examination of the samples will be done in the end. <br>