Cardiovascular Risk Factor
Conditions
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
Interventions
DIETARY_SUPPLEMENTAkP06
first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet
DIETARY_SUPPLEMENTPlacebo
first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of LDL-Cholesterol levels | 4 weeks |
Secondary
| 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 |
Countries
Italy
Outcome results
None listed