Effects of LopiGLIK® on Cardiovascular Risk

Cardiovascular Risk Factors Clinical Trial

— LopiWEB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898805
• Other study ID #: AKP_3
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: July 2019
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 1, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factors

Intervention

Other:
• Placebo

• Prescribed Diet

Dietary Supplement:
• LopiGLIK®

• Armolipid Plus

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Carrizzo A, Ambrosio M, Damato A, Madonna M, Storto M, Capocci L, Campiglia P, Sommella E, Trimarco V, Rozza F, Izzo R, Puca AA, Vecchione C. Morus alba extract modulates blood pressure homeostasis through eNOS signaling. Mol Nutr Food Res. 2016 Oct;60(10 — View Citation

Trimarco V, Izzo R, Stabile E, Rozza F, Santoro M, Manzi MV, Serino F, Schiattarella GG, Esposito G, Trimarco B. Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of LDL-Cholesterol levels		16 weeks
Secondary	Increasing of HDL-Cholesterol levels		16 weeks
Secondary	Reduction of HbA1c levels		16 weeks
Secondary	Reduction of fastin insuline levels		16 weeks