Metabolic health in neurodegenerative diseases - implications of metabolic characteristics and gut microbiome
- Conditions
- G20G30E88.9Parkinson diseaseAlzheimer diseaseMetabolic disorder, unspecified
- Registration Number
- DRKS00030597
- Lead Sponsor
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
•BMI 18,5-39,9 kg/m²
•Non-smoker (for at least 3 months)
written declaration of consent for participation in the study.
•Diagnosis Parkinson disease or Alzheimer disease
PD cohort:
•PD based on clinical diagnosis according to Brain Bank criteria(Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson’s disease. A clinico-pathological study of 100 cases. JNNP 1992;55:181-184.)
•Hoehn & Yahr stadium 1-3
AD cohort
•Clinical and biomarker-based diagnosis with Alzheimer's pathology based on typical CSF findings
Mixed dementia with a vascular component (up to Fazekas II) is permitted.
•Taking medications that affect glucose metabolism
•chronic hepatic diseases, gastrointestinal diseases, chronic inflammatory diseases or other severe diseases
•antibiotic therapy 3 weeks before the start of the study
•Planned lifestyle changes
•regular intake of supplements
•drug abuse
•participation in another clinical trial simultaneously/in the last 30 days
PD cohort:
•Atypical PD syndromes
•DBS care
•severe motor fluctuations
AD cohort:
•Dementia of unclear origin
•Heavy vascular part (Fazekas III)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Metabolic differences
- Secondary Outcome Measures
Name Time Method intestinal microbiome (composition, diversity), concentration of various intestinal hormones, parameter of intestinal permeability, parameter of glucose and lipid metabolism, parameter of inflammation, neuroinflammation and antioxidative defence, short chain fatty acids (SCFAs), amino acids, serotonin, electrolytes. <br><br>Further parameters: anthropometrics (body weight, body height, waist and hip ratio, body composition (BodPod), resting energy expenditure (QuarkRMR), cognition, transit time, nutritional behaviour, physical activity, socio-economic status, chronobiology, gynaecological history.<br><br>Security parameters: small blood count, parameters of renal and hepatic function (GOT, GPT, GGT, bilirubin, uric acid, urea, creatinine).<br>