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

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

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 Overview

• Status: Completed
• Conditions: Low-Moderate Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Red Rice Yeast; Other: Placebo Group

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Hospital General Universitari de Valencia
  • Canarias
    • Las Palmas De Gran Canaria, Canarias, Spain
      • Hospitales San Roque
  • Catalunya
    • Barcelona, Catalunya, Spain
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Group; 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; Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months
Placebo Comparator: Placebo Group; One tablet per day of placebo.	Other: Placebo Group; Participants of this group will take one tablet of placebo per day for a period of six months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bioksan
• Collaborators: Analysis and Research Network, S.L

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Red yeast rice
• Other Study ID Numbers: BIO-LIP-01-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No