About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Probiotic
Dietary supplementParticipants will receive a probiotic for 60 days to allow comparison of the results with those observed in the placebo arm. Participants will take one probiotic capsule once daily in the morning, on an empty stomach.
Treatment groups
Trial outcomes
Primary outcomes
Blood glucose assessment with OGTT test and FGM
Blood glucose and insulin tests at 0', 30', 60', 90', 120' minutes every 30 minutes Blood glucose monitoring at home
Pressure assessment
Blood pressure is assessed during the visit at time 0 and after 60 days Filling out a blood pressure diary at home
Secondary outcomes
Anthropometric measurements
Weight is assessed in Kg with the use of the bioimpedance balance.
Anthropometric measurements
the height is measured in cm through a wall altimeter
Anthropometric measurements
the BMI (body mass index) is calculated by making the ratio of the weight to the square of the height. normal weight is defined as 18.5-24.9 kg/m², overweight as 25.0-29.9 kg/m², and obesity as ≥30.0 kg/m
Anthropometric measurements
Waist, hip, arm, and calf circumferences are measured using an inelastic measuring tape. Waist circumference is also assessed as an indicator of abdominal obesity and increased cardiometabolic risk, using the following reference cut-off values for European populations: ≥94 cm in men and ≥80 cm in women.
Sponsors and contacts
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