Development of Smart Food /Nutraceutical Solutions Dedicated to Cardiometabolic Disorders in Ageing

The clinical research is aimed at exploring the in vivo functionality in humans of ingredients produced and formulated at a pre-competitive pilot level, namely the ability to reduce blood pressure or modify the RAAS (renin-angiotensin-aldosterone system) through the presence of substrates with ACE-inhibitory activity, and/or improve metabolic status through the administration of probiotic strains whose products have a known metabolic effect in in vitro, in vivo animal, or human models (in other subject categories). The use of "enhanced bioactive compounds" (ACE inhibitors, pre-, pro-, and post-biotics) together with selected probiotics in newly formulated food supplements may be strategic in supporting specific diets and pharmacological treatments in older adults with cardiometabolic disorders (CVD). The result of these technological convergences will culminate with the in vivo trial of some nutraceutical-food systems useful for the well-being of the elderly suffering from cardiometabolic pathologies (CVDs).

Inclusion criteria

• Patients of either gender, over 65 years of age, able to understand the protocol procedures.
• Known cardiovascular disease
• Prediabetes or type 2 diabetes mellitus with HbA1c < 7.0% on diet alone or metformin.

Exclusion criteria

• Age under 65
• Previous diagnosis of type 2 diabetes mellitus already undergoing drug therapy (except metformin)
• Contraindications such as allergy to product components
• Obesity secondary to diseases: genetic (Prader-Willi syndrome, Down syndrome); metabolic and endocrine (Cushing's syndrome, hypothyroidism)
• Endocrine or liver disease or clinical evidence of chronic disease or gastrointestinal disorders or malabsorption disorders
• History of adrenal adenoma or secondary arterial hypertension due to renal/adrenal causes
• Arterial hypertension treated with an ACE inhibitor or ARB
• Previous bariatric surgery