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

Randomized, Single-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effect of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: AkP06; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Raffaele Izzo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AkP06; first two weeks: Placebo + prescribed Diet then 4 weeks AkP06 two tablet/day before meals + Diet	Dietary supplement: AkP06; first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet
Placebo Comparator: Placebo; first two weeks: Placebo + prescribed Diet then 4 weeks Placebo two tablet/day before meals + Diet	Dietary supplement: Placebo; first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of LDL-Cholesterol levels	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AkP_6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No