Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

April 16, 2015 updated by: Matteo Pirro, University Of Perugia

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

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
placebo
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
Active Comparator: Nutraceutical combination
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in LDL cholesterol at 3 months
Time Frame: 3 months after treatment randomization
3 months after treatment randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Circulating endothelial microparticles at 3 months
Time Frame: 3 months after treatment randomization
3 months after treatment randomization
Change from Baseline in C-reactive protein at 3 months
Time Frame: 3 months after treatment randomization
3 months after treatment randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matteo Pirro, MD, PhD, University of Perugia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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