CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)

• Outpatients of both genders, with CIMT > 1.00 mm suffering from hypertension and/or type II diabetes and/or hypercholesterolemia, under stable treatment for these conditions since at least 6 months.
• Age between 45-65
• BMI > 26 ≤35
• Total cholesterol ≥ 200 ≤ 240 mg/dL
• BP mm Hg: Mx ≥ 135 ≤ 160 ; Mn ≥ 75 ≤ 90 the subject must remain 10 min at rest in clinostatic position before measurement
• Blood glucose Mn ≥ 80 ; Mx ≤ 130 mg/dL
• The subjects suffering from hypertension, and/or diabetes, and/or hypercholesterolemia can be admitted provided that the diseases under chronic treatment are mitigated with no more than 2 drugs. By drug we mean any formulation (in tablets, capsules, fluid etc..) containing one or more active ingredients. This therapy has to be administered 4 hours before or after the product under evaluation.
• ESC score (European Society of Cardiology) \< 10
• Informed consent must be obtained prior to participation.
• Subjects able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
• Subjects must be willing and able to give informed consent/assent for participation in the study.
• Negative pregnancy test for women with childbearing capacity.

Exclusion criteria

• Age \< 45 or > 65 years.
• Pregnancy or breastfeeding. During the study, women of reproductive age will have to use reliable contraceptive methods.
• Mx BP > 160 Mn > 90 despite a treatment of 6 months with common antihypertensive
• Total cholesterol > 240 mg/dL despite a treatment of 6 months with the common hypolipemic drugs
• Morning blood glucose > 130 mg/dL despite a treatment of 6 months with common oral hypoglycemic drugs
• BMI > 35
• ESC score (European Society of Cardiology) ≥ 10
• Myocardial infarction
• Neurological disorders
• Cancer
• Gout
• Kidney dysfunction (creatinine > 3 mg/dl)
• Liver dysfunction (ALT > 40 U/L)
• COPD (FEV \< 80% of predicted value)
• Psychiatric diseases
• IBS
• Anemia (HB \< 10 g/dl)
• Inability or unreliability of the Food Intake Assessment [4]
• Hypersensitivity to polyglucosamine
• Any medical condition or abnormality of clinical laboratory tests that needs systemic pharmacological treatment besides treatment for hypertension, type II diabetes or hypercholesterolemia. This means that local treatments will be allowed.
• Vulnerable subjects: incapacitated, immunocompromised, or other conditions which may bring to a condition of vulnerability.
• Subjects under emergency circumstances
• Treatment with orally applicable drugs exceeding application in the morning and in the late evening
• Current treatment with GLP-1 agonists, fosinopril, acarbose.
• In the case of treatment with food supplements the subject can be enrolled after 1 month of product withdrawal.
• Known allergy to crustaceans or one of the ingredients
• Chronic constipation
• Intestinal obstruction
• Intake of long-term medications that significantly slow down intestinal activity
• Current participation in any other investigational trials