NCT03340285

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AkP06	first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet
DIETARY_SUPPLEMENT	Placebo	first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-03-31
• Completion: 2018-12-01
• First posted: 2017-11-13
• Last updated: 2019-07-30

Locations

1 site across 1 country: Italy