Nutraceuticals and Vascular Remodelling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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RYR plus CoQ

333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily

Liposcudil Plus

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Liposcudil Plus

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Total Cholesterol \> 150 mg/dl and \< 250 mg/dl;
* Triglycerides \> 150 mg/dl and \< 500 mg/dl;
* Fasting glucose \< 126 mg/dl;
* Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.

Exclusion Criteria

* Total Cholesterol \> 250 mg/dl
* Triglycerides \> 500 mg/dl
* Previous statin therapy (last 6 months);
* Treatment with hypoglycemic agents and/or fasting glucose \> 126 mg/dl;
* Chronic gastrointestinal disorders;
* Chronic kidney disease (eGFR \< 60 ml/min/1.73 m2);
* Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
* Proven intolerance to any component of the nutraceutical product;
* Pregnancy or breastfeeding.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes