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

oryza granulata/obesitas

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

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