Skip to main content
Clinical Trials/DRKS00015861
DRKS00015861
Completed
未知

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

Institut für Ernährungs- und Lebensmittelwissenschaften, Abteilung Ernährungsphysiologie, Rheinische Friedrich-Wilhelms-Universität Bonn0 sites120 target enrollmentJanuary 28, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
cardio metabolic risk
Sponsor
Institut für Ernährungs- und Lebensmittelwissenschaften, Abteilung Ernährungsphysiologie, Rheinische Friedrich-Wilhelms-Universität Bonn
Enrollment
120
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 28, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

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

Eligibility 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

  • 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;
  • 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)

Outcomes

Primary Outcomes

Not specified

Similar Trials