Effects of LopiGLIK® on Cardiovascular Risk

Study Overview
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Brief Summary
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The study is designed to compare the effects of two combination of nutraceuticals: Armolipid Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment with one of the combinations, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of the two combinations to reduce the levels of total and LDL cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.

Detailed Description
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The experimental design involves the construction of a multi-center, controlled, randomized, single-blind, versus Armolipid Plus®. Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will be recruited, from the beginning of the study and for the next 2 weeks, from 30 Cv specialists and/or GPs (25 patients each). The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in order to obtain a proper comparison between groups with similar demographic characteristics or not statistically different. The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into two groups, subjected to centralized randomization at the Diagnosis and Treatment of hypertension Center to receive one of two different treatments, a tablet/day of the new nutraceutical LopiGLIK® (Akademy Pharma) containing Morus Alba, immediately after a meal, vs. a tablet/day of Armolipid Plus, always immediately after the meal. During the first two weeks both groups will follow the prescribed diet and assume the placebo. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) and the endothelial function will be assesed. During the next 16 weeks a group will assume LopiGLIK® (Akademy Pharma) containing Morus Alba, the other will assume Armolipid Plus and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of Armolipid Plus, LopiGLIK® and placebo will be provided by Akademy Pharma free of charge

Official Title
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Effects of a New Combination of Nutraceutics (LopiGLIK®) on Cardiovascular Risk

Conditions
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Cardiovascular Risk Factors

Intervention / Treatment
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* Other: Placebo
* Other: Prescribed Diet
* Dietary Supplement: LopiGLIK®
* Dietary Supplement: Armolipid Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total Cholesterol<300 mg/dL Total Cholesterol>200 mg/dL Cardiovascular Risk<20% Exclusion Criteria: Pregnancy Documented intolerance to one or more 'components LOPIGLIK / Armolipid PLUS Previous cardiovascular events Familiar severe dyslipidemia Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LopiGLIK®<br>first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet | Other: Placebo<br> <br> Other: Prescribed Diet<br> <br> Dietary Supplement: LopiGLIK®<br> <br> |
| Active Comparator: Armolipid Plus<br>first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet | Other: Placebo<br> <br> Other: Prescribed Diet<br> <br> Dietary Supplement: Armolipid Plus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of LDL-Cholesterol levels |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increasing of HDL-Cholesterol levels |  | 16 weeks | 
| Reduction of HbA1c levels |  | 16 weeks | 
| Reduction of fastin insuline levels |  | 16 weeks |