Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 228 for:    yeast

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828006
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Analysis and Research Network, S.L
Information provided by (Responsible Party):
Bioksan

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.

Condition or disease Intervention/treatment Phase
Low-Moderate Hypercholesterolemia Dietary Supplement: Red Rice Yeast Other: Placebo Group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828006


Locations
Layout table for location information
Spain
Hospitales San Roque Recruiting
Las Palmas De Gran Canaria, Canarias, Spain
Contact: Javier Martínez    +34 928 40 40 40      
Principal Investigator: Javier Martínez         
Hospital Universitari de Bellvitge Recruiting
Barcelona, Catalunya, Spain
Contact: Xavier Pintó    +34 932 60 75 00      
Principal Investigator: Xavier Pintó         
Hospital General Universitari de València Recruiting
Valencia, Spain
Contact: Juan J Tamarit, PhD    +34 963 13 18 00      
Principal Investigator: Juan J Tamarit, PhD         
Sponsors and Collaborators
Bioksan
Analysis and Research Network, S.L

Layout table for additonal information
Responsible Party: Bioksan
ClinicalTrials.gov Identifier: NCT03828006     History of Changes
Other Study ID Numbers: BIO-LIP-01-18
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Red yeast rice
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents