Role of the immune system and the gut microbiota in neuroprotection: a dietary human intervention trial

Not Applicable

Conditions: cardio metabolic risk

Registration Number: DRKS00015861

Lead Sponsor: Institut für Ernährungs- und Lebensmittelwissenschaften, Abteilung Ernährungsphysiologie, Rheinische Friedrich-Wilhelms-Universität Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 120

Inclusion Criteria

• Caucasian participants aged 45-70 years
• BMI 27-39,9 kg/m²
• at least one trait of the metabolic syndrome: (i) central obesity (waist circumference = 94 cm for men and = 80 cm for women); (ii) hypertension (=140–159 mmHg SBP and/or =90–99 mmHg DBP); (iii) dyslipidemia (fasting serum triglyceride concentrations =1.7 mmol/l and/or serum concentrations of HDL-cholesterol <1.0 mmol/l for men and <1.3 mmol/l for women)
(IV) proinflammatory state (high-sensitive C-reactive protein =2 mg/l)
• Written declaration of consent to study participation

Exclusion Criteria

• smoking;
• type 2 diabetes mellitus;
• chronic liver, gastrointestinal, or in?ammatory disease (hs-CRP > 30 mg/L) including rheumatoid Arthritis
• history of cardiovascular events;
• untreated thyroid dysfunction;
• cancer;
• recent major surgery or illness;
• pregnancy or lactation;
• alcohol, drug or medication use disorder;
• regular consumption of dietary supplements notably n-3 fatty acids, Vitamin E and/or Magnesium
• vegetarians
• food intolerance (fish)
• participation in a weight loss program (last 30 days)
• use of antibiotics (last four weeks)
• medical discretion

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in GLP-1 (Peptidhormon Glucagon-like Peptide 1) plasma concentration at day 0, 1, 2, after 3 wks (d22) and after 6 wks (d41 and d42), in each case at various time points

Secondary Outcome Measures

Name	Time	Method
inflammation: Cytokine-panel, Tumornekrosefaktor a (TNF-a), high sensitive C-reactive Protein (hs-CRP))<br>neuroinflammation/ neurodegeneration (neurofilament light (NFL), glial fibrillary acidic protein (GFAP), amyloid-beta (Aß) 42/40, phosphorylated tau (p-tau) 181, 217 and 231, and total-tau, O-link panel) <br>glucose metabolism: Blood glucose, insulin HbA1c, insuline resistance<br>lipid metabolism: lipids and lipoproteins, free fatty acids, lipidomics;<br>lipopolysaccharide (LPS);<br>short chain fatty acids (SCFA) in faeces; <br>bacterial diversity of the gut microbiota (16S and WGS); <br>expression of G-Protein coupled receptors in gut tissue;<br>resting energy expenditure<br>at day 0, 1, 2, after 3 wks (d22) and after 6 wks (d41 and d42), at various time points <br>