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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: AkP06

• Registration Number: NCT03340285
• Lead Sponsor: Federico II University

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

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2017-12-01
• Primary Completion: 2018-03-31
• 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: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reduction of LDL-Cholesterol levels	4 weeks

Secondary Outcome Measures

Name	Time	Method
Increasing of HDL-Cholesterol levels	4 weeks
Reduction of HbA1c levels	4 weeks
Reduction of fastin insuline levels	4 weeks
No alteration of transaminase levels	4 weeks
No alteration of CPK levels	4 weeks

Trial Locations

Locations (1)

Raffaele Izzo; 🇮🇹 Naples, Italy