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

Bioksan

Status: Completed

Conditions: Low-Moderate Hypercholesterolemia

Treatments: Other: Placebo Group; Dietary Supplement: Red Rice Yeast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03828006

BIO-LIP-01-18

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Active Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Red Rice Yeast

Placebo Group

Placebo Comparator group

Description:

One tablet per day of placebo.

Treatment:

Other: Placebo Group