Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

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

Group Type ACTIVE_COMPARATOR

Calcium-Propionate 500mg

Intervention Type DIETARY_SUPPLEMENT

Calcium-Propionate capsules

Arm 2

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsules without any active ingredient

Interventions

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Calcium-Propionate 500mg

Calcium-Propionate capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsules without any active ingredient

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No