Development of Smart Food /Nutraceutical Solutions Dedicated to Cardiometabolic Disorders in Ageing
Recruiting · NCT07817290 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- SCDU Endocrinology. AOU Ospedale Maggiore della Carità - Novara, Italy