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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: AkP06
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AkP06<br>first two weeks: Placebo + prescribed Diet then 4 weeks AkP06 two tablet/day before meals + Diet | Dietary Supplement: AkP06<br>* first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet<br>|
| Placebo Comparator: Placebo<br>first two weeks: Placebo + prescribed Diet then 4 weeks Placebo two tablet/day before meals + Diet | Dietary Supplement: Placebo<br>* first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |