Trial | NCT03828006  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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.
Study Started
Dec 13
2018
Primary Completion
Nov 30
2020
Study Completion
Nov 30
2020
Last Update
Jul 21
2022

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

Other Placebo Group

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

Active Group Experimental

One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient

Placebo Group Placebo Comparator

One tablet per day of placebo.

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.
No Results Posted