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

Low-Moderate Hypercholesterolemia

Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months

Red Rice Yeast

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

Placebo Group

Hospitales San Roque

Hospital Universitari de Bellvitge

Hospital General Universitari de València

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

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.

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.

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%

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.

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.

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.

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.

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.

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.

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.

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.

The number of returned product will be counted

Bioksan

Analysis and Research Network, S.L

One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.

One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.

One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.
Nutraceutical combination: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

Nutraceutical Combination

One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.
Placebo: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

Placebo

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

LDL blood cholesterol level

Mean change in blood LDL cholesterol level from randomization (day 0) to V4 (week 8)

Change in Blood LDL Cholesterol Level

Mean change in total blood LDL cholesterol level from randomization (day 0) to V4 (week 8)

Change in Total Blood Cholesterol Level

Mean change in blood HDL cholesterol level from randomization (day 0) to V4 (week 8)

Change in Blood HDL Cholesterol Level

Mean change in blood non-HDL cholesterol level from randomization (day 0) to V4 (week 8)

Change in Blood Non-HDL Cholesterol Level

Mean change in blood triglycerides level from randomization (day 0) to V4 (week 8)

Change in Blood Triglycerides Level

Mean change in blood apolipoprotein B level from randomization (day 0) to V4 (week 8)

Change in Blood Apolipoprotein B Level

Mean change in total cholesterol/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)

Change in Total Cholesterol/HDL Cholesterol Ratio

Mean change in LDL/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)

Change in Total LDL Cholesterol/HDL Cholesterol Ratio

Mean change in Pulse Volume (PV) waveform from randomization (day 0) to V4 (week 8).
PV unit of measurement is a percent change in the PV waveform area, comparing waveforms during and before hyperemia through the equation √PV2/PV1 that relates PV at baseline (PV1) and PV during hyperemia (PV2).

Change in Pulse Volume (PV) Waveform (Endothelial Reactivity)

Mean change in Glycemia from randomization (day 0) to V4 (week 8)

Change in Glycemia

Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)

Change in Aspartate Aminotransferase (AST)

Change in Alanine Aminotransferase (ALT)

Mean change gamma glutamyl transpeptidase (GGT) from randomization (day 0) to V4 (week 8)

Change in Gamma Glutamyl Transpeptidase (GGT)

Mean change in Serum Creatinine values from randomization (day 0) to V4 (week 8)

Change in Serum Creatinine

Mean change in Serum uric acid values from randomization (day 0) to V4 (week 8)

Change in Serum Uric Acid

Mean change in creatine phosphokinase (CPK) from randomization (day 0) to V4 (week 8)

Change in Creatine Phosphokinase (CPK)

Overall Study

Dr Paolo Fabrizzi Clinical Operation Director

Hypercholesterolemia

One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

Nutraceutical combination

Policlinico S.Orsola - Malpighi Medicina Interna Borghi

Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels

A Randomized, Double-blinded, Placebo-controlled, Clinical Study of the Effects of a Nutraceutical Combination on LDL Cholesterol Levels in Subjects With Sub-optimal Blood Cholesterol Levels

A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Dyslipidemias

patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.

Coleosoma

patients will take one tablet daily for 12 weeks.

Endocrinology Unit

Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

Randomized Controlled Clinical Trial for Assessing Tolerability and Effectiveness of Formula Coleosoma 29 in Patients With Dyslipidemia

Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.

Difference in the Free Plasma Glucose value compared to baseline in the 2 arms.

Difference in the BMI value compared to baseline in the 2 arms.

Difference in the waist circumference value compared to baseline in the 2 arms.

Difference in the HbA1C value compared to baseline in the 2 arms.

Difference in theLDL Cholesterol, triglycerides and HDL cholesterol value compared to baseline in the 2 arms.
All these parameters have the same Units of Measure (mg/dl)

Difference in the ApoB/Apo A1ratio compared to baseline in the 2 arms.

Difference in the inflammatory cytokines value compared to baseline in the 2 arms.
All these parameters have the same Units of Measure (pg/ml)

Difference in the insulin value compared to baseline in the 2 arms.

Difference in the hormone profile compared to baseline in the 2 arms. All these parameters have the same Units of Measure (pg/ml)

Difference in the EPC number compared to baseline in the 2 arms.

Alessandra Dei Cas

Research Assistant, MD, PhD

Azienda Ospedaliero-Universitaria di Parma

DOC generici srl

The study included two arms: a treatment arm with dietary supplement (Coleosoma) and a placebo arm.
Coleosoma is the name of a new patented dietary supplement composed by Berberin 200 mg, Fermented Red Rice from Monascus purpureus 100 mg (correspondiing at 3 mg of monacolin K), Chitosan 100 mg e Q10 Coenzyme10 mg

oryza sativa/triglyceride

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

Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels

Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

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