M06.9
Conditions
Interventions
Group 1: 30 patients will receive a twice-daily regimen of a dietary ketogenic supplement for 8 weeks followed by a second twice-daily regimen of combining ketogenic compound and fiber for additional
Sponsors
Dr. Schär AG / SPA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed Rheumatoid Arthritis 2. On stable medication 3. Fluent in German
Exclusion criteria
Exclusion criteria: 1. Other inflammatory diseases 2. Severe mental illness (impaired compliance) 3. BMI = 30 4. Vegan diet 5. Coconut oil rich diet 6. Pro- and prebiotic food supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score reduction of SDAI indices before and after intervention (4 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in disease activity in terms of DAS-28 (Disease Activity Score-28), ESR, CRP and morning stiffness (in minutes) before and after the intervention (0, 2, 4 months). 2. Change in functional status in terms of HAQ (Health Assessment Questionnaire) before and after the intervention (0, 2, 4 months). 3. Change in mood/depressiveness in terms of BDI (Beck Depression Inventory) and PHQ-9 (Patient Health Questionnaire-9) before and after the intervention (0, 2, 4 months). 4. Change in health-related quality of life with regard to SF-36 (Short Form-36) before and after the intervention (0, 2, 4 months). 5. Change in fatigue symptoms and physical activity with regard to MFI (Multidimensional Fatigue Inventory) and FFkA (Freiburg Physical Activity Questionnaire) before and after the intervention (0, 2, 4 months). 6. Changes in various blood values before and after intervention (0, 2, 4 months) including: - Lipids, metabolic profile (CRP, TG, LDL, HDL, Chol, rheumatoid factor, creatinine, urea, potassium, sodium, blood count, diff.-BB, GPT, GOT, GGT). - Cellular measurements: distribution of different immune cell populations in peripheral blood mononuclear cells (PBMCs); activation levels of monocytes (M1 and M2) and T cells, Th1/T17 and, Treg cells, expression of adhesion molecules. - Inflammatory cytokines, factors and insulin including IL-1, HMGB-1, RAGE, IL-6, IL-18, Il-1beta, IL-17, TNF-alpha, Nesfatin-1, IL-35. - Redox status including lipoxygenases (LOX), cyclooxygenases (COX) and gluthathione peroxidases (GPx) as well as their metabolites. Change in the faecal microbiome during the intervention, including: - Microbiome (quantitative cultural detection of E. coli, Enterococcus sp., Bifidobacterium sp., Lactobacillus sp., fungi, etc.) - Faecal fatty acid profile (butyrate, acetate, propionate, iso-butyrate, iso-valerate) - Alpha 1-Antitrypsin, Zonulin, Calprotectin, LPS 7. Change in metabolic profile in urine and stool over the course | — |
Countries
Germany
Contacts
Public ContactMonika Reuss-Borst
Schwerpunktpraxis für Rheumatologie
Outcome results
None listed