Effects of LopiGLIK® on Cardiovascular Risk

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

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-01

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.

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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

Conditions

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Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LopiGLIK®

first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Prescribed Diet

Intervention Type OTHER

LopiGLIK®

Intervention Type DIETARY_SUPPLEMENT

Armolipid Plus

first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Prescribed Diet

Intervention Type OTHER

Armolipid Plus

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type OTHER

Prescribed Diet

Intervention Type OTHER

LopiGLIK®

Intervention Type DIETARY_SUPPLEMENT

Armolipid Plus

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes