Clinical trial NCT03828006: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low-Moderate Hypercholesterolemia
Lead sponsor: Bioksan
Sponsor class: INDUSTRY
Collaborators: name: Analysis and Research Network, S.L
First posted: 2019-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Systematic Coronary Risk Evaluation (SCORE)
timeFrame: Changes in the score from the baseline, at 3 and 6 months.
measure: Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)
timeFrame: Changes in the score from the baseline, at 3 and 6 months.
measure: Registre Gironi del Cor (REGICOR)
timeFrame: Changes in the score from the baseline, at 3 and 6 months.
Secondary outcomes:
measure: Changes in LDL cholesterol levels in blood
timeFrame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
measure: Changes in HDL cholesterol levels in blood
timeFrame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
measure: Changes in triglycerides levels in blood
timeFrame: Changes in the triglyceride levels from the baseline, at 3 and 6 months.
measure: Changes in lipoprotein levels in blood
timeFrame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
measure: Levels of glycosylated hemoglobin in blood
timeFrame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
measure: Alanine Transaminase (ALT) levels
timeFrame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
measure: Adverse Events
timeFrame: Through study completion, an average of 9 months
measure: Therapeutic adherence
timeFrame: At the 6 month visit
measure: Morisky-Green scale
timeFrame: At the 6 month visit
measure: Recount of returned product
timeFrame: At the 6 month visit
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospitales San Roque
state: Canarias
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
state: Catalunya
city: Valencia
country: Spain
facility: Hospital General Universitari de València
Study officials:
References: