Effects of LopiGLIK® on Cardiovascular Risk

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Cardiovascular Risk Factors

Clinical Trial Details

NCT number	NCT02898805
Study type	Interventional
Source	Federico II University
Contact
Status	Completed
Phase	N/A
Start date	January 2016
Completion date	December 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06405880` - Pharmacist Case Finding and Intervention for Vascular Prevention Trial	N/A
Completed	`NCT02589769` - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons	N/A
Recruiting	`NCT01902654` - Osteoarthritis Cardiovascular Risk Factors	N/A
Completed	`NCT01698034` - Volunteering and Cardiovascular Risk in Adolescents	N/A
Recruiting	`NCT01231152` - The Impact of Obesity on Children and Adolescents.	N/A
Completed	`NCT00983333` - Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program	N/A
Terminated	`NCT00527436` - Fish Oil and Biomarkers of Cardiovascular Risk	N/A
Recruiting	`NCT02917928` - The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health	Phase 2
Active, not recruiting	`NCT02490683` - Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.	N/A
Recruiting	`NCT02282748` - Swiss Longitudinal Cohort
Completed	`NCT01252316` - Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers	Phase 1/Phase 2
Completed	`NCT01190592` - Resistance Training With Milk Supplementation in Adolescents	N/A
Withdrawn	`NCT01087411` - Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children	N/A
Completed	`NCT00787306` - Cardiovascular Health And Risk Modification in Family Health Teams	Phase 3
Completed	`NCT01260441` - An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program	Phase 1
Completed	`NCT04025463` - Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV	N/A
Completed	`NCT02922920` - Effects of Tart Cherry Juice on the Body	N/A
Completed	`NCT01514656` - CPR Training: Video Self-Instruction Kit or Video-Only	N/A
Completed	`NCT01134029` - Planned CORR: Planned Care for Obesity and Risk Reduction	N/A
Active, not recruiting	`NCT00786890` - A Survey to Evaluate the Cardiovascular Risk Status of Subjects With Pre-Diabetes in Hong Kong	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of LopiGLIK® on Cardiovascular Risk — LopiWEB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms