Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

Sponsor

University Of Perugia (Other)

Overall Status

Completed

CT.gov ID

NCT02422927

Collaborator

(none)

100

Enrollment

Arms

7.1

Duration (Months)

Study Details

Study Description

Brief Summary

The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Inflammation Hypercholesterolemia	Dietary Supplement: Nutraceutical Combination Other: Standard of Care Other: Placebo	Phase 4

Detailed Description

Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL 100-160 mg / dL) and hsCRP levels> 2 mg / L, divided into two groups of equal numbers, matched by by sex and age, randomized to receive a nutraceutical combination containing red yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a low-cholesterol diet (<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).

All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed randomization in the two intervention arms: NC + SOC or SOC.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard of Care + Placebo low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo	Other: Standard of Care low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule Other: Placebo placebo
Active Comparator: Nutraceutical combination low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination	Dietary Supplement: Nutraceutical Combination red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily Other Names: Armolipid Plus, Rottapharm-Madaus Other: Standard of Care low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule

Arm

Intervention/Treatment

Placebo Comparator: Standard of Care + Placebo

low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo

Other: Standard of Care

low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule

Other: Placebo

placebo

Active Comparator: Nutraceutical combination

low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination

Dietary Supplement: Nutraceutical Combination

red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily

Other Names:

Armolipid Plus, Rottapharm-Madaus

Other: Standard of Care

low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule

Outcome Measures

Primary Outcome Measures

Change from Baseline in LDL cholesterol at 3 months [3 months after treatment randomization]

Secondary Outcome Measures

Change from Baseline in Circulating endothelial microparticles at 3 months [3 months after treatment randomization]
Change from Baseline in C-reactive protein at 3 months [3 months after treatment randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

LDL cholesterol <160 mg/dl (4,14 mmol/l);
hsCRP >2 mg/L;

Exclusion Criteria:

triglycerides >500 mg/dL (5.6 mmol/L);
current or previous treatment with lipid-lowering drugs or with other drugs supposed to modify vascular damage and/or repair (antiplatelet, anti-hypertensive and antioxidant drugs);
current or previous treatment with hormone replacement therapy for menopause vasomotor symptoms;
evidence of liver dysfunction or alanine-aminotransferase (ALT) levels twice above the upper normal limit;
creatin-kinase (CK) levels thrice above the upper normal limit
history or clinical evidence of previous or current cardiovascular disease;
presence of strong cardiovascular risk factors such as: serum creatinine levels >2 mg/dL, diabetes mellitus, uncontrolled systemic arterial hypertension (systolic blood pressure >190 mg/dL or diastolic blood pressure >100 mg/dL); history of cancer in the former 5 years before recruitment; not adequately treated hypothyroidism (TSH levels

1,5 times the upper normal limit);

history of malignancy in the previous 5 years before screening;
not adequately treated hypothyroidism (TSH levels >1,5 times the upper normal limit);
previous or current alcohol or drugs abuse;
history or clinical evidence of chronic inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory bowel disease;
current or previous use of immunosuppressant agents or long term glucocorticoids
history or clinical evidence of any severe concomitant disease which may compromise subject's safety or its possibility to carry out the study.