cardio metabolic risk
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| inflammation: Cytokine-panel, Tumornekrosefaktor a (TNF-a), high sensitive C-reactive Protein (hs-CRP)) 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) glucose metabolism: Blood glucose, insulin HbA1c, insuline resistance lipid metabolism: lipids and lipoproteins, free fatty acids, lipidomics; lipopolysaccharide (LPS); short chain fatty acids (SCFA) in faeces; bacterial diversity of the gut microbiota (16S and WGS); expression of G-Protein coupled receptors in gut tissue; resting energy expenditure at day 0, 1, 2, after 3 wks (d22) and after 6 wks (d41 and d42), at various time points | — |
Countries
Germany
Contacts
Institut für Ernährungs- und Lebensmittelwissenschaften, Abteilung Ernährung & Mikrobiota