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

Primary Purpose

Low-Moderate Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Red Rice Yeast
Placebo Group
Sponsored by
Bioksan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-Moderate Hypercholesterolemia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospitales San Roque
  • Hospital Universitari de Bellvitge
  • Hospital General Universitari de València

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Group

Placebo Group

Arm Description

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

One tablet per day of placebo.

Outcomes

Primary Outcome Measures

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.
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.
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%

Secondary Outcome Measures

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 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 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 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.
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.
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.
Adverse Events
Number of adverse events.
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.
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.
Recount of returned product
The number of returned product will be counted

Full Information

First Posted
January 10, 2019
Last Updated
July 20, 2022
Sponsor
Bioksan
Collaborators
Analysis and Research Network, S.L
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1. Study Identification

Unique Protocol Identification Number
NCT03828006
Brief Title
Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
Official Title
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioksan
Collaborators
Analysis and Research Network, S.L

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-Moderate Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
One tablet per day of placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Red Rice Yeast
Intervention Description
Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months
Intervention Type
Other
Intervention Name(s)
Placebo Group
Intervention Description
Participants of this group will take one tablet of placebo per day for a period of six months
Primary Outcome Measure Information:
Title
Systematic Coronary Risk Evaluation (SCORE)
Description
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.
Title
Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)
Description
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.
Title
Registre Gironi del Cor (REGICOR)
Description
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 Outcome Measure Information:
Title
Changes in LDL cholesterol levels in blood
Description
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.
Title
Changes in HDL cholesterol levels in blood
Description
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.
Time Frame
Changes in the cholesterol levels from the baseline, at 3 and 6 months.
Title
Changes in triglycerides levels in blood
Description
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.
Time Frame
Changes in the triglyceride levels from the baseline, at 3 and 6 months.
Title
Changes in lipoprotein levels in blood
Description
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.
Time Frame
Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Title
Levels of glycosylated hemoglobin in blood
Description
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.
Time Frame
Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Title
Alanine Transaminase (ALT) levels
Description
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.
Time Frame
Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Title
Adverse Events
Description
Number of adverse events.
Time Frame
Through study completion, an average of 9 months
Title
Therapeutic adherence
Description
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.
Time Frame
At the 6 month visit
Title
Morisky-Green scale
Description
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.
Time Frame
At the 6 month visit
Title
Recount of returned product
Description
The number of returned product will be counted
Time Frame
At the 6 month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospitales San Roque
City
Las Palmas De Gran Canaria
State/Province
Canarias
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
State/Province
Catalunya
Country
Spain
Facility Name
Hospital General Universitari de València
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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