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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340285
• Other study ID #: AkP_6
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 1, 2018
• Est. primary completion date: March 31, 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 of AkP06

• 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 Factor

Intervention

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

Locations

Country	Name	City	State
Italy	Raffaele Izzo	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of LDL-Cholesterol levels		4 weeks
Secondary	Increasing of HDL-Cholesterol levels		4 weeks
Secondary	Reduction of HbA1c levels		4 weeks
Secondary	Reduction of fastin insuline levels		4 weeks
Secondary	No alteration of transaminase levels		4 weeks
Secondary	No alteration of CPK levels		4 weeks