M79.7
Conditions
Interventions
Group 1: Ketogenic diet plus routine care
Patients keep a ketogenic diet ad libitum without calorie restrictions for three weeks. Carbohydrates should account for less than 10% of the daily calory int
Sponsors
Klinik für Anaesthesiologie, LMU Klinikum, LMU München
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Medically confirmed diagnosis of fibromyalgia syndrome (FMS) according to the criteria of the American college of Rheumatology (ACR) • Written informed consent
Exclusion criteria
Exclusion criteria: • current other out- or inpatient treatment for FMS • planned other out- or inpatient treatment for FMS during the study period • Pregnancy or breastfeeding • Current haemoglobin level 13 or clinical diagnosis) • Acute illness • Neuropathy or polyneuropathy of other origin • Untreated thyroid disease • Serious metabolic disorder (e.g. diabetes mellitus HbA1 C > 48 mmol/mol Hb) • Autoimmune diseases • Nickel and/or copper allergy • Personal relationship to the investigators (family members, relatives)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline-adjusted difference in the total score of the Fibromyalgia Impact Questionnaire in its revised version (FIQ-R) after three weeks of ketogenic diet (t1) plus routine treatment compared to three weeks of routine treatment alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Unless otherwise stated, the following secondary study endpoints are defined as the baseline-adjusted group difference in outcome measures post-intervention (directly and three months after the intervention phase). • FIQ-R sumsocre three months after the intervention phase • Psychological symptoms (subscores of the Depression, Anxiety and Stress Scales (DASS)) • Health-related quality of life (SF36 questionnaire) • Body mass index (BMI) • Percentage of fat, water, muscle and bone in the body • Analgesic demand: total over the three-week intervention phase (diary) and overall assessment at three months after the intervention phase • Parameters of immune homeostasis of immune cells analysed ex vivo (peripheral blood mononuclear cells (PBMC) such as T cells and their subpopulations as well as NK cells) o Protein secretion of proinflammatory cytokines and chemokines (IFNy, IL-2, IL-4, IL-6, IL-10, IL-17, IL-1ß, TNF) from in vitro stimulated immune cells and after TruCulture whole blood stimulation ex vivo o mRNA and protein expression of further inflammatory parameters (pro- and anti-inflammatory) in PBMC (subpopulations: IFNy, IL-2, IL-4, IL-6, IL-10, IL-17, IL-1ß, FOXP3, RORc, GATA3, T-bet, CTLA, STAT5, NFkB, GZMB, Prf, TNF) o mRNA, microRNA, protein and metabolite expression profiles relevant to inflammation (array analyses, next-generation sequencing (NGS), Luminex, mass spectrometry analyses) o Immune cell typing by Flow cytometry (proportion of specific subpopulations: T cells (Th17, Treg, Th1, Th2; NK cells, Myeloid-Derived Suppressor Cells (MDSC)), T cell activation and differentiation into T cell subpopulations, NK cell activity/exhaustion (CD107a, PD-1, CD69, DNAM)) o Functionally analysed T-cell and NK-cell immune function: cytotoxicity assays, proliferation rate o Mitochondrial analyses: quantification of mitochondrial membrane potential, production of reactive oxygen species (ROS), mitochondrial mass, protein quantification of respiratory c | — |
Countries
Germany
Contacts
Public ContactDominik Irnich
Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, LMU Klinikum, LMU München
Outcome results
None listed