Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

Safety and Efficacy of PROPionatE for Reduction of LDL Cholesterol (PROPER-LDL Trial) - A Phase 2 Randomized Placebo Controlled Double-blind Trial

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.

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.

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