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Completed

NCT Number: NCT03828006

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.

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Key information

Conditions

Low-Moderate Hypercholesterolemia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospitales San Roque, Las Palmas de Gran Canaria, Canary Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo Group

Other

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

Primary outcomes

  1. Systematic Coronary Risk Evaluation (SCORE)

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

    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.

  2. Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)

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

    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.

  3. Registre Gironi del Cor (REGICOR)

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

    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 outcomes

  1. Changes in LDL cholesterol levels in blood

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

    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.

  2. Changes in HDL cholesterol levels in blood

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

    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.

  3. Changes in triglycerides levels in blood

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

    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.

  4. Changes in lipoprotein levels in blood

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

    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.

  5. Levels of glycosylated hemoglobin in blood

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

    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.

  6. Alanine Transaminase (ALT) levels

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

    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.

  7. Adverse Events

    Time frame: Through study completion, an average of 9 months

    Number of adverse events.

  8. Therapeutic adherence

    Time frame: At the 6 month visit

    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.

  9. Morisky-Green scale

    Time frame: At the 6 month visit

    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.

  10. Recount of returned product

    Time frame: At the 6 month visit

    The number of returned product will be counted

Sponsors and collaborators

Lead sponsor

Bioksan

Industry

Collaborators

  • Analysis and Research Network, S.L

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.