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

ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    Participants 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

15 Participants
are divided into 1 treatment group
Group A: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4 months
2

Pressure assessment

Blood pressure is assessed during the visit at time 0 and after 60 days Filling out a blood pressure diary at home

Time frame
4 months

Secondary outcomes

1

Anthropometric measurements

Weight is assessed in Kg with the use of the bioimpedance balance.

Time frame
evaluation of weight and body composition through study completion, an average of 4 months
2

Anthropometric measurements

the height is measured in cm through a wall altimeter

Time frame
evaluation of weight and body composition through study completion, an average of 4 months
3

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

Time frame
evaluation of weight and body composition through study completion, an average of 4 months
4

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.

Time frame
evaluation of weight and body composition through study completion, an average of 4 months

Other outcomes

Sponsors and contacts

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