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

Study Overview
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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.

Official Title
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Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk

Conditions
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Low-Moderate Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Red Rice Yeast
* Other: Placebo Group


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Group<br>One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient | Dietary Supplement: Red Rice Yeast<br>* Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months<br>|
| Placebo Comparator: Placebo Group<br>One tablet per day of placebo. | Other: Placebo Group<br>* Participants of this group will take one tablet of placebo per day for a period of six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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% | Changes in the score from the baseline, at 3 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Changes in the cholesterol levels from the baseline, at 3 and 6 months. | 
| Changes in HDL cholesterol levels in blood | HDL cholesterol will be 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. | Changes in the cholesterol levels from the baseline, at 3 and 6 months. | 
| Changes in triglycerides levels in blood | Triglycerides will be 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. | Changes in the triglyceride levels from the baseline, at 3 and 6 months. | 
| Changes in lipoprotein levels in blood | Lipoproteins will be 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. | Changes in the lipoprotein levels from the baseline, at 3 and 6 months. | 
| Levels of glycosylated hemoglobin in blood | Glycosylated Hemoglobin (HbA1c) will be measured as % in blood Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake. | Changes in the lipoprotein levels from the baseline, at 3 and 6 months. | 
| Alanine Transaminase (ALT) levels | Levels of ALT Transaminase measured in IU/L. Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake. | Changes in the lipoprotein levels from the baseline, at 3 and 6 months. | 
| Adverse Events | Number of adverse events. | Through study completion, an average of 9 months | 
| Therapeutic adherence | Data will be collected by the investigator at participant visits with a unique question about percentage of intake. It will be considered a good compliance if the 80% of the medication has been taken. | At the 6 month visit | 
| Morisky-Green scale | The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1. Possible result values goes from 0 to 4, being 0 less adherence and 4 more adherence. | At the 6 month visit | 
| Recount of returned product | The number of returned product will be counted | At the 6 month visit |