Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590496
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Arash Haghikia, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Atorvastatin 10mg Dietary Supplement: Calcium-Propionate 500mg Other: Placebo Phase 2

Detailed Description:
124 patients with hypercholesterolemia (LDL serum level > 115 mg/dl) will be enrolled. 62 patients with moderate cardiovascular risk will be 1:1 randomized to receive either Placebo (b.i.d.) or 500mg of propionate (b.i.d.) in addition to their basic cholesterol lowering treatment with 10mg Atorvastatin per day. Another 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of PROPionatE for Reduction of LDL Cholesterol (PROPER-LDL Trial) - A Phase 2 Randomized Placebo Controlled Double-blind Trial
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) in addition to their basic cholesterol lowering therapy with 10mg Atorvastatin (once per day) for 8 weeks.
Drug: Atorvastatin 10mg
Atorvastatin-Calcium Film-coated tablets

Dietary Supplement: Calcium-Propionate 500mg
Calcium-Propionate capsules

Placebo Comparator: Arm 2
31 patients will be treated with placebo capsules (twice a day) in addition to their basic cholesterol lowering therapy with 10mg Atorvastatin (once per day) for 8 weeks.
Drug: Atorvastatin 10mg
Atorvastatin-Calcium Film-coated tablets

Other: Placebo
Placebo capsules without any active ingredient

Active Comparator: Arm 3
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 4
31 patients will be treated with placebo capsules (twice a day) for 8 weeks.
Other: Placebo
Placebo capsules without any active ingredient




Primary Outcome Measures :
  1. LDL-cholesterol reduction [ Time Frame: 8 weeks ]
    mg/dL


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590496


Contacts
Layout table for location contacts
Contact: Arash Haghikia, PD MD (0)30450513797 ext +49 arash.haghikia@charite.de
Contact: Paul Schumann, PhD candidate (0)30450513807 ext +49 paul.schumann@charite.de

Locations
Layout table for location information
Germany
St. Josef-hospital Ruhr-Univesity Bochum Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44791
Contact: Christos Krogias, PD MD    +492345092411    christos.krogias@ruhr-uni-bochum.de   
Principal Investigator: Christos Krogias, PD Dr. med.         
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12203
Contact: Arash Haghikia, PD MD    (0)30450513797 ext +49    arash.haghikia@charite.de   
Contact: Paul Schumann    (0)30450513807 ext +49    paul.schumann@charite.de   
Principal Investigator: Arash Haghikia, PD MD         
Sub-Investigator: Friederike Zimmermann, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Principal Investigator: Arash Haghikia, PD MD Charite University, Berlin, Germany

Publications:

Layout table for additonal information
Responsible Party: Arash Haghikia, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03590496     History of Changes
Other Study ID Numbers: PROPER-LDL Trial
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arash Haghikia, Charite University, Berlin, Germany:
propionate
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors