DRKS00015861Completed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 enrollmentStarted: January 28, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (—)
- Sex
- All
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)
- •participation in a weight loss program (last 30 days)
- •use of antibiotics (last four weeks)
- •medical discretion
Investigators
Similar Trials
Completed
Not Applicable
The influence of the gut microbiome on immunity mediated by COVID-19 vaccinatiohealthy volunteersDRKS00027050Institut für Prävention und Tumorepidemiologie143
Completed
Not Applicable
The role of the microbiota in the systemic immune responsesepsis10019815NL-OMON36859Academisch Medisch Centrum12
Not yet recruiting
Not Applicable
Het effect van antibiotica en de darmflora op afweerreactiesEndotoxemiaNL-OMON27487Academic Medical Centre, Amsterdam16
Completed
Not Applicable
The effect of antibiotics and the gut flora on the immune system.sepsis, gut flora depletion, systemic immune responseNL-OMON27808Academisch Medisch Centrum, Amsterdam12
Recruiting
Not Applicable
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCTGraft Vs Host DiseaseNCT06143501The First Affiliated Hospital of Soochow University250