Effects of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose

NCT ID: NCT03340285

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-01

Brief Summary

The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism.

The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, 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 AkP 06 to reduce the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase those of HDL cholesterol.

In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration will be evaluated.

Detailed Description

The experimental design involves the construction of a placebo-controlled, randomized, single-blind, parallel-groups.

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 at the outpatients Hypertension Clinic.

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, to a computer based randomization scheme to receive one of two different treatments, two tablet/day before meals of the new nutraceutical AkP06 (Akademy Pharma) containing Morus Alba and without Monacolin K, vs. two tablet/day of placebo, always before meals. During the first two weeks both groups will follow the prescribed diet and assume placebo tablets. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) will be performed. During the next 4 weeks a group will assume AkP06 (Akademy Pharma) containing Morus Alba and without Monakolin K, the other will assume placebo and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of AkP06 and placebo will be provided by Akademy Pharma free of charge

Conditions

Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

AkP06

first two weeks: Placebo + prescribed Diet then 4 weeks AkP06 two tablet/day before meals + Diet

Group Type: EXPERIMENTAL

AkP06

Intervention Type: DIETARY_SUPPLEMENT

first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet

Placebo

first two weeks: Placebo + prescribed Diet then 4 weeks Placebo two tablet/day before meals + Diet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet

Interventions

AkP06

first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet

Intervention Type: DIETARY_SUPPLEMENT

Placebo

first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 of AkP06
• 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

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Bruno Trimarco

PROF OF CARDIOLOGY

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Trimarco, Professor

Role: PRINCIPAL_INVESTIGATOR

FEDERICO II UNIVERSITY - NAPLES

Locations

Raffaele Izzo

Naples, , Italy

Countries

Italy

Other Identifiers

AkP_6

Identifier Type: -

Identifier Source: org_study_id