Trial Outcomes & Findings for Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels (NCT NCT03739242)

NCT ID: NCT03739242

Last Updated: 2019-10-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
• Results posted on: 2019-10-14

Participant Flow

Participant milestones

Measure	Nutraceutical Combination 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)	Placebo 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)
Overall Study STARTED	44	44
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Nutraceutical Combination 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)	Placebo 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)
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)	Total n=85 Participants Total of all reporting groups
Age, Continuous	51.28 years STANDARD_DEVIATION 9.56 • n=5 Participants	51.79 years STANDARD_DEVIATION 10.74 • n=7 Participants	51.53 years STANDARD_DEVIATION 10.10 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Italy	43 participants n=5 Participants	42 participants n=7 Participants	85 participants n=5 Participants
LDL blood cholesterol level	154.27 mg/dL STANDARD_DEVIATION 20.47 • n=5 Participants	160.57 mg/dL STANDARD_DEVIATION 20.84 • n=7 Participants	157.38 mg/dL STANDARD_DEVIATION 20.77 • n=5 Participants

PRIMARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Blood LDL Cholesterol Level	-32.48 mg/dL Standard Deviation 30.18	2.54 mg/dL Standard Deviation 19.44

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Total Blood Cholesterol Level	-31.99 mg/dL Standard Deviation 34.05	7.17 mg/dL Standard Deviation 21.10

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Blood HDL Cholesterol Level	0.78 mg/dL Standard Deviation 7.17	1.11 mg/dL Standard Deviation 7.37

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Blood Non-HDL Cholesterol Level	-33.35 mg/dL Standard Deviation 22.99	3.65 mg/dL Standard Deviation 18.78

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Blood Triglycerides Level	-1.44 mg/dL Standard Deviation 42.76	17.62 mg/dL Standard Deviation 60.48

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Blood Apolipoprotein B Level	-14.79 mg/dL Standard Deviation 15.05	1.6 mg/dL Standard Deviation 14.29

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Total Cholesterol/HDL Cholesterol Ratio	-0.79 ratio Standard Deviation 0.79	0.06 ratio Standard Deviation 0.64

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Total LDL Cholesterol/HDL Cholesterol Ratio	-0.76 ratio Standard Deviation 0.70	-0.01 ratio Standard Deviation 0.52

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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).

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Pulse Volume (PV) Waveform (Endothelial Reactivity)	-0.08 percentage of change Standard Deviation 0.25	-0.03 percentage of change Standard Deviation 0.21

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Glycemia	-0.88 mg/dL Standard Deviation 6.26	-1.57 mg/dL Standard Deviation 5.78

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Aspartate Aminotransferase (AST)	0.98 U/L Standard Deviation 4.01	0.86 U/L Standard Deviation 3.40

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Alanine Aminotransferase (ALT)	4.53 U/L Standard Deviation 9.29	2.93 U/L Standard Deviation 9.75

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Gamma Glutamyl Transpeptidase (GGT)	0.91 U/L Standard Deviation 9.83	3.07 U/L Standard Deviation 9.53

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Serum Creatinine	0 mg/dL Standard Deviation 0.08	0 mg/dL Standard Deviation 0.10

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Serum Uric Acid	-0.30 mg/dL Standard Deviation 0.98	0 mg/dL Standard Deviation 0.56

SECONDARY outcome

Timeframe: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Population: Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).

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

Outcome measures

Measure	Nutraceutical Combination n=43 Participants 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)	Placebo n=42 Participants 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)
Change in Creatine Phosphokinase (CPK)	2.09 U/L Standard Deviation 48.76	-7.00 U/L Standard Deviation 56.56

Adverse Events

Nutraceutical Combination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paolo Fabrizzi Clinical Operation Director

A. Menarini Industrie Farmaceutiche Riunite SrL

Phone: +39 055 5680459

Email: pfabrizzi@menarini.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60