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

Bioksan100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Low-Moderate Hypercholesterolemia

Interventions

Red Rice YeastDIETARY_SUPPLEMENT

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

Placebo GroupOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (3)

Hospitales San Roque

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitari de Bellvitge

Barcelona, Catalonia, Spain

Hospital General Universitari de València

Valencia, Spain

Outcomes

Primary Outcomes

Systematic Coronary Risk Evaluation (SCORE)

This scale estimates the 10 year risk of fatal CVD. The risk is estimated with a High \& Low cardiovascular Risk Charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. High risk or low risk table depends on whether the person lives in a high or low risk country. There possible scores goes from 0 to 47 in the high risk table, and 0 to 26 in the low risk table. Where lower values represent lower risk and higher values higher risk.

Time frame: Changes in the score from the baseline, at 3 and 6 months.

Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)

Calculates 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines on de Assessment of Cardiovascular Risk.

Time frame: Changes in the score from the baseline, at 3 and 6 months.

Registre Gironi del Cor (REGICOR)

The scale measures the probability of having cardiovascular disease in 10 years. The probability is estimated with age, sex, smoking status, diabetic or not, total Cholesterol (mg/dl), HDL cholesterol (mg/dl), systolic blood pressure (mmHg) and diastolic blood pressure (mmHg). Possible risk values are divided in 5 categories: low \<5%, moderate 6-9%, medium 10-19%, high 20-38%, very high \>39%

Time frame: Changes in the score from the baseline, at 3 and 6 months.

Secondary Outcomes

Changes in LDL cholesterol levels in blood

LDL in blood measured in mg/dL Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.

Time frame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.

Changes in HDL cholesterol levels in blood

Data from ClinicalTrials.gov

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