Effects of LopiGLIK® on Cardiovascular Risk

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factors
• Interventions: Other: Placebo; Other: Prescribed Diet; Dietary Supplement: Armolipid Plus; Dietary Supplement: LopiGLIK®

• Registration Number: NCT02898805
• Lead Sponsor: Federico II University

Brief Summary

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

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

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Primary Completion: 2018-01
• Study Completion: 2018-12-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LopiGLIK®	Prescribed Diet	first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet
Armolipid Plus	Armolipid Plus	first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet
LopiGLIK®	LopiGLIK®	first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet
LopiGLIK®	Placebo	first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet
Armolipid Plus	Placebo	first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet
Armolipid Plus	Prescribed Diet	first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet

Primary Outcome Measures

Name	Time	Method
Reduction of LDL-Cholesterol levels	16 weeks

Secondary Outcome Measures

Name	Time	Method
Increasing of HDL-Cholesterol levels	16 weeks
Reduction of fastin insuline levels	16 weeks
Reduction of HbA1c levels	16 weeks

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy