Status:
COMPLETED
Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
Lead Sponsor:
Bioksan
Collaborating Sponsors:
Analysis and Research Network, S.L
Conditions:
Low-Moderate Hypercholesterolemia
Eligibility:
All Genders
18-99 years
Phase:
NA
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 cho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03828006
Start Date
December 13 2018
End Date
November 30 2020
Last Update
July 21 2022
Active Locations (3)
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1
Hospitales San Roque
Las Palmas de Gran Canaria, Canary Islands, Spain
2
Hospital Universitari de Bellvitge
Barcelona, Catalonia, Spain
3
Hospital General Universitari de València
Valencia, Spain