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

NCT03828006 | Completed

• 1 other identifier: BIO-LIP-01-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Low-Moderate Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Changes in LDL cholesterol levels in blood

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

• Changes in HDL cholesterol levels in blood

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

• Changes in triglycerides levels in blood

  Changes in the triglyceride levels from the baseline, at 3 and 6 months.

• Changes in lipoprotein levels in blood

  Changes in the lipoprotein levels from the baseline, at 3 and 6 months.

• Levels of glycosylated hemoglobin in blood

  Changes in the lipoprotein levels from the baseline, at 3 and 6 months.

Study Arms (2)

Active Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

One tablet per day of placebo.

Other: Placebo Group

Interventions

Red Rice Yeast DIETARY_SUPPLEMENT

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

Active Group

Placebo Group OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Body Mass Index (BMI) between 18.5 y 29.9.
• LDL-c levels between 100mg/dL and 160mg/dL
• year estimated cardiovascular risk assessed by the ASCVD less than 20%
• Accepts to participate and sings Informed Consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioksan: lead
• Analysis and Research Network, S.L: collaborator

Study Sites (3)

Hospitales San Roque

Las Palmas de Gran Canaria, Canary Islands, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Catalonia, Spain

Location

Hospital General Universitari de València

Valencia, Spain

Location

MeSH Terms

Interventions

red yeast rice

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: February 4, 2019
• Study Start: December 13, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

ES (3)