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

September 14, 2020 updated by: Arash Haghikia, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.
Dietary supplement: Calcium-Propionate 500mg
Calcium-Propionate capsules
Placebo Comparator: Arm 2
31 patients will be treated with placebo capsules (twice a day) for 8 weeks.
Other: Placebo
Placebo capsules without any active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-cholesterol reduction
Time Frame: 8 weeks
mg/dL
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total cholesterol
Time Frame: 8 weeks
mg/dL
8 weeks
HDL-cholesterol
Time Frame: 8 weeks
mg/dL
8 weeks
non HDL
Time Frame: 8 weeks
mg/dL
8 weeks
Ratio HDL/LDL
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Arash Haghikia, PD MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPER-LDL Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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