Hypercholesterolemia
Conditions
Keywords
propionate
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.
Interventions
DIETARY_SUPPLEMENTCalcium-Propionate 500mg
Calcium-Propionate capsules
OTHERPlacebo
Placebo capsules without any active ingredient
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-cholesterol reduction | 8 weeks | mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total cholesterol | 8 weeks | mg/dL |
| HDL-cholesterol | 8 weeks | mg/dL |
| non HDL | 8 weeks | mg/dL |
| Ratio HDL/LDL | 8 weeks | — |
Countries
Germany
Outcome results
None listed