Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

NCT03590496 | Completed DMC

• 1 other identifier: PROPER-LDL Trial
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

propionate

Outcome Measures

Primary Outcomes (1)

• LDL-cholesterol reduction

  mg/dL

  8 weeks

Secondary Outcomes (4)

• total cholesterol

  8 weeks

• HDL-cholesterol

  8 weeks

• non HDL

  8 weeks

• Ratio HDL/LDL

  8 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium-Propionate 500mg

Arm 2

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Calcium-Propionate 500mg DIETARY_SUPPLEMENT

Calcium-Propionate capsules

Arm 1

Placebo OTHER

Placebo capsules without any active ingredient

Arm 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Related Publications (7)

• 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.

  PMID: 27040132 BACKGROUND

• 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.

  PMID: 26039521 BACKGROUND

• 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.

  PMID: 25722430 BACKGROUND

• 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.

  PMID: 8813902 BACKGROUND

• 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.

  PMID: 27892486 BACKGROUND

• 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.

  PMID: 25500202 BACKGROUND

• 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.

  PMID: 34597388 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Propionates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Arash Haghikia, PD MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: July 25, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)