Safety and Efficacy of Propionate for Reduction of LDL Cholesterol
Not Applicable
Completed
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT03590496
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
The objective of the trial is to evaluate a potential impact of food supplements with the short chain fatty acid propionate on blood LDL cholesterol level.
- Detailed Description
62 patients with low cardiovascular risk will be 1:1 randomized to receive either placebo (b.i.d.) or 500mg of propionate (b.i.d.). The primary endpoint is the change (delta) in blood LDL cholesterol levels after 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- patients with hypercholestrolemia and a LDL serum level of > 115 mg/dl
- age of patient between 20 and 70 years
- participant is fully competent and has given his/her written informed consent to the scheduled trial conduct
Exclusion Criteria
- patients with acute coronary syndrome in the last 4 weeks
- patients with chronic symptomatic heart failure (NYHA 2-4)
- patients with chronic renal failure and a GFR < 45 ml/min
- patients with chronic liver disease
- patients with hematological diseases
- patients with severe diseases of other organ systems (tumors, infections)
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method LDL-cholesterol reduction 8 weeks mg/dL
- Secondary Outcome Measures
Name Time Method non HDL 8 weeks mg/dL
Ratio HDL/LDL 8 weeks total cholesterol 8 weeks mg/dL
HDL-cholesterol 8 weeks mg/dL
Trial Locations
- Locations (1)
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Charité Universitätsmedizin Berlin🇩🇪Berlin, Germany