Low-Moderate Hypercholesterolemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTRed Rice Yeast
Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months
OTHERPlacebo Group
Participants of this group will take one tablet of placebo per day for a period of six months
Sponsors
Analysis and Research Network, S.L
Bioksan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systematic Coronary Risk Evaluation (SCORE) | 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. |
| Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD) | 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. |
| Registre Gironi del Cor (REGICOR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipoprotein levels in blood | 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. |
| Levels of glycosylated hemoglobin in blood | 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. |
| Alanine Transaminase (ALT) levels | 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. |
| Changes in LDL cholesterol levels in blood | 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. |
| Therapeutic adherence | 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. |
| Morisky-Green scale | 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. |
| Recount of returned product | At the 6 month visit | The number of returned product will be counted |
| Adverse Events | Through study completion, an average of 9 months | Number of adverse events. |
| Changes in HDL cholesterol levels in blood | 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. |
| Changes in triglycerides levels in blood | 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. |
Countries
Spain
Outcome results
None listed