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Metabolic health in neurodegenerative diseases - implications of metabolic characteristics and gut microbiome

Recruiting
Conditions
G20
G30
E88.9
Parkinson disease
Alzheimer disease
Metabolic 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
Inclusion Criteria

•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.

Exclusion Criteria

•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
NameTimeMethod
Metabolic differences
Secondary Outcome Measures
NameTimeMethod
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>
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