Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Calcium-Propionate 500mg; Other: Placebo

• Registration Number: NCT03590496
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-18
• Study Start: 2018-07-25
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Calcium-Propionate 500mg	31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.
Arm 2	Placebo	31 patients will be treated with placebo capsules (twice a day) for 8 weeks.

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol reduction	8 weeks	mg/dL

Secondary Outcome Measures

Name	Time	Method
non HDL	8 weeks	mg/dL
Ratio HDL/LDL	8 weeks
total cholesterol	8 weeks	mg/dL
HDL-cholesterol	8 weeks	mg/dL

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany