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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Calcium-Propionate 500mg
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring propionate

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.

31 patients will be treated with placebo capsules (twice a day) for 8 weeks.

Outcomes

Primary Outcome Measures

LDL-cholesterol reduction
mg/dL

Secondary Outcome Measures

total cholesterol
mg/dL
HDL-cholesterol
mg/dL
non HDL
mg/dL
Ratio HDL/LDL

Full Information

First Posted
July 6, 2018
Last Updated
September 14, 2020
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03590496
Brief Title
Safety and Efficacy of Propionate for Reduction of LDL Cholesterol
Acronym
PROPER-LDL
Official Title
Safety and Efficacy of PROPionatE for Reduction of LDL Cholesterol (PROPER-LDL Trial) - A Phase 2 Randomized Placebo Controlled Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
propionate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
31 patients will be treated with placebo capsules (twice a day) for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium-Propionate 500mg
Intervention Description
Calcium-Propionate capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules without any active ingredient
Primary Outcome Measure Information:
Title
LDL-cholesterol reduction
Description
mg/dL
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
total cholesterol
Description
mg/dL
Time Frame
8 weeks
Title
HDL-cholesterol
Description
mg/dL
Time Frame
8 weeks
Title
non HDL
Description
mg/dL
Time Frame
8 weeks
Title
Ratio HDL/LDL
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Haghikia, PD MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27040132
Citation
Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, Lopez-Jaramillo P, Leiter LA, Dans A, Avezum A, Piegas LS, Parkhomenko A, Keltai K, Keltai M, Sliwa K, Peters RJ, Held C, Chazova I, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Sanchez-Vallejo G, McKelvie R, Pogue J, Jung H, Gao P, Diaz R, Lonn E; HOPE-3 Investigators. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016 May 26;374(21):2021-31. doi: 10.1056/NEJMoa1600176. Epub 2016 Apr 2.
Results Reference
background
PubMed Identifier
26039521
Citation
Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.
Results Reference
background
PubMed Identifier
25722430
Citation
Kataoka Y, St John J, Wolski K, Uno K, Puri R, Tuzcu EM, Nissen SE, Nicholls SJ. Atheroma progression in hyporesponders to statin therapy. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):990-5. doi: 10.1161/ATVBAHA.114.304477. Epub 2015 Feb 26.
Results Reference
background
PubMed Identifier
8813902
Citation
Berggren AM, Nyman EM, Lundquist I, Bjorck IM. Influence of orally and rectally administered propionate on cholesterol and glucose metabolism in obese rats. Br J Nutr. 1996 Aug;76(2):287-94. doi: 10.1079/bjn19960032.
Results Reference
background
PubMed Identifier
27892486
Citation
Lu Y, Fan C, Li P, Lu Y, Chang X, Qi K. Short Chain Fatty Acids Prevent High-fat-diet-induced Obesity in Mice by Regulating G Protein-coupled Receptors and Gut Microbiota. Sci Rep. 2016 Nov 28;6:37589. doi: 10.1038/srep37589.
Results Reference
background
PubMed Identifier
25500202
Citation
Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10.
Results Reference
background
PubMed Identifier
34597388
Citation
Haghikia A, Zimmermann F, Schumann P, Jasina A, Roessler J, Schmidt D, Heinze P, Kaisler J, Nageswaran V, Aigner A, Ceglarek U, Cineus R, Hegazy AN, van der Vorst EPC, Doring Y, Strauch CM, Nemet I, Tremaroli V, Dwibedi C, Krankel N, Leistner DM, Heimesaat MM, Bereswill S, Rauch G, Seeland U, Soehnlein O, Muller DN, Gold R, Backhed F, Hazen SL, Haghikia A, Landmesser U. Propionate attenuates atherosclerosis by immune-dependent regulation of intestinal cholesterol metabolism. Eur Heart J. 2022 Feb 10;43(6):518-533. doi: 10.1093/eurheartj/ehab644.
Results Reference
derived

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Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

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