N18 G35
Conditions
Interventions
Group 1: This is an exploratory, mechanistic study in which patients will consume a balanced, standardized, plant-based diet for five days (exposure). There will be a total of five study time points:
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: For all patients: - Men and women in a 1:1 ratio - Age 18-60 years - Body Mass Index 18,5 - 29,9 kg/m2 - Stool frequency every 1-2 days - Ability to consent - Existing health insurance CKD patients: - Chronic renal failure stage 3 (GFR 30- 59 ml/min) - Polycystic kidney disease For MS patients: - Relapsing-remitting MS according to MS diagnosis according to McDonald 2017 - EDSS smaller than 4.5 - Stable immunomodulatory therapy or no immunomodulatory therapy min. 6 months prior to inclusion
Exclusion criteria
Exclusion criteria: For all patients: - Diseases or functional disorders that, in the opinion of the study physician, preclude participation in the study - Autoimmune diseases (except MS) - Diabetes mellitus type 2 - Postoperative phase - Acute infection - Malnutrition - Smoker (abstinence for at least 6 months) - Vegetarian - vegans - Food intolerances - Food allergies - Taking antibiotics within the last 3 months - Regular intake of probiotics and/or prebiotics - Change in body weight of more than 2 kg in the previous month of the study - Pregnancy and lactation - Known medication, drug or alcohol abuse - Incapacity or other circumstances that do not allow the patient to fully understand the nature, meaning and implications of this study. For CKD patients: - CKD due to other underlying diseases, e.g., diabetes, glomerulonephritis For MS patients: - Initiation of or change in immunomodulatory therapy during the study - Cortisone treatment in the last 30 days before inclusion - Relapse in the last 30 days before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum activation potential of AhR measured in vitro using a cell-based assay with AhR reporter cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reduction of systolic and diastolic blood pressure - Decrease in pulse wave velocity (PWV) - Change in taxonomic and functional composition of the gut microbiota - Alteration of mRNA expression of AhR-specific genes in whole blood - Change in metabolite patterns in serum, stool, and 24h urine - Change in tryptophan metabolites, amino acids and related amines, short chain fatty acids, purines, fatty acid profiles and fatty acid methyl esters in plasma, stool and 24h urine - Altered abundances of pro- and anti-inflammatory immune cells - Increase of anti-inflammatory circulating cytokines in plasma - Change in the expression of bacterial genes responsible for enzymes for the formation of metabolites that are relevant to host health - Improved intestinal barrier function | — |
Countries
Germany
Contacts
Public ContactVictoria McParland
Charité - Universitätsmedizin Berlin
Outcome results
None listed