Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2020-11-30

Brief Summary

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This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the dietary supplement or a placebo during a six months period.

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Detailed Description

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Conditions

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Low-Moderate Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Group

One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient

Group Type EXPERIMENTAL

Red Rice Yeast

Intervention Type DIETARY_SUPPLEMENT

Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months

Placebo Group

One tablet per day of placebo.

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type OTHER

Participants of this group will take one tablet of placebo per day for a period of six months

Interventions

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Red Rice Yeast

Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months

Intervention Type DIETARY_SUPPLEMENT

Placebo Group

Participants of this group will take one tablet of placebo per day for a period of six months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older
* Body Mass Index (BMI) between 18.5 y 29.9.
* LDL-c levels between 100mg/dL and 160mg/dL
* 10 year estimated cardiovascular risk assessed by the ASCVD less than 20%
* Accepts to participate and sings Informed Consent.

Exclusion Criteria

* Patients with history of cardiovascular diseases.
* Patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver or thyroid diseases.
* Patients with muscle diseases
* Patients undergoing pharmacological treatment with any of the following: lipid lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or during the last 2 months.
* Patients with proven intolerance with the components present in the dietary supplement.
* Patients with any other concomitant disease that to the researcher's criteria are not susceptible to participate in the study.
* Woman that are pregnant, in breastfeeding period or with a possibility of starting a pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No