Safety and Efficacy of Propionate for Reduction of LDL Cholesterol (PROPER-LDL)

Charité University Medicine Berlin

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Other: Placebo; Dietary Supplement: Calcium-Propionate 500mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03590496

PROPER-LDL Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.

Treatment:

Dietary Supplement: Calcium-Propionate 500mg

Arm 2

Placebo Comparator group

Description:

31 patients will be treated with placebo capsules (twice a day) for 8 weeks.

Treatment:

Other: Placebo