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Recruiting
NCT07817290
Development of Smart Food /Nutraceutical Solutions Dedicated to Cardiometabolic Disorders in Ageing
Conditions: Prediabetes
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 15
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Location: SCDU Endocrinology. AOU Ospedale Maggiore della Carità Novara
Summary
Describe the anthropometric measurements and informations relating to body composition, blood chemistry tests, blood glucose monitoring, and dietary habits of the volunteers participating in the study before and after taking probiotics.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07817290). StuddyBuddy aggregates publicly available trial information.