Evaluation of the Hypolipidemic Effect of Bergavit by a Human Trial.

The study duration is 4 months. Subjects will attend clinic visits as follows:

• T0: First visit: assessment of all baseline parameters, Beginning of treatment
• T2: Second visit: assessment only of LDL level, Total cholesterol, ox-LDL, Triglycerides level, fasting glucose.
• T3: Third visit: assessment of all parameters.
• T4: Fourth visit: assessment of all parameters, end of the treatment.

Inclusion criteria

• 1 Healthy men and women (40-70 years old);
• 2 Asian subjects with LDL-cholesterol (ranging from 100 to 159; see here below)
• 3 Subjects naïve to statins or other treatment and food supplement that can interfere with the study treatment for the previous 1 month
• 4 Reading, understanding and signed approval of the informative consent
• 5 No vegetarian. Subjects who will continue, expect reserve, their normal lifestyle
• 6 Healthy volunteers without clinical illness diagnosed with relevant effect on the gastrointestinal system or the motility visceral

Exclusion criteria

• 1 Subjects <40 and >70 years old
• 2 Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
• 3 lack of compliance defined as not using the correct Bergavit dose or placebo for>1 week), and inability to give informed consent
• 4 Subjects who have changed their diet significantly or have been placed on weight reduction products
• 5 Smokers, Obesity subjects, during breast feeding
• 6 Changing the eating habits within the 2 weeks previous the screening
• 7 During the pregnancy of the subjects or of the subjective planning of the study
• 8 Subjects with a history of drug, alcohol and other substance abuse
• 9 Known food intolerance or food allergy
• 10 Subjects involved in a clinical or food study within the previous month
• 11 Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
• 12 Subjects with a history of paralysis or cerebral vascular accident
• 13 Subjects with active cancers or on chemotherapy