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

Charité University Medicine Berlin logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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