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Completed

NCT Number: NCT03590496

Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Berlin

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium-Propionate 500mg

Dietary Supplement

Calcium-Propionate capsules

Placebo

Other

Placebo capsules without any active ingredient

Primary outcomes

  1. LDL-cholesterol reduction

    Time frame: 8 weeks

    mg/dL

Secondary outcomes

  1. total cholesterol

    Time frame: 8 weeks

    mg/dL

  2. HDL-cholesterol

    Time frame: 8 weeks

    mg/dL

  3. non HDL

    Time frame: 8 weeks

    mg/dL

  4. Ratio HDL/LDL

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: PROPER-LDL

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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