NCT02422927

Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Atherosclerosis
• Inflammation
• Hypercholesterolemia

Interventions

Type	Name	Description
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	Standard of Care	low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
OTHER	Placebo	placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2015-04-22
• Last updated: 2015-04-22