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PROPER-LDL: Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT03590496
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
23.2
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Calcium-Propionate 500mg
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
62 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 :
Jul 25, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. LDL-cholesterol reduction [8 weeks]

    mg/dL

Secondary Outcome Measures

  1. total cholesterol [8 weeks]

    mg/dL

  2. HDL-cholesterol [8 weeks]

    mg/dL

  3. non HDL [8 weeks]

    mg/dL

  4. Ratio HDL/LDL [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité Universitätsmedizin Berlin Berlin Germany 12203

Sponsors and Collaborators

  • Charite University, Berlin, Germany

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Arash Haghikia, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT03590496
Other Study ID Numbers:
  • PROPER-LDL Trial
First Posted:
Jul 18, 2018
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arash Haghikia, Principal Investigator, Charite University, Berlin, Germany
propionate
Additional relevant MeSH terms:
Hypercholesterolemia
Calcium

Study Results

No Results Posted as of Sep 16, 2020