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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
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.
SCDU Endocrinology. AOU Ospedale Maggiore della Carità
Novara, Italy
RECRUITINGBlood 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
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
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
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
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
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
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Adherence level to the Western diet with European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaires
Assessed with the use of questionnaire. EPIC is used for the bromatology evaluation of the diet, so there aren't scales but only indication about the macro and micronutrient composition. This is a qualitative questionnaires and not quantitative.
Time frame: evaluation of weight and body composition through study completion, an average of 4 months
Adherence level to the Western diet with 24h recall questionnaires
Assessed with the use of questionnaires. 24h recall questionnaire is used for the bromatology evaluation of the diet, so there aren't scales but only indication about the macro and micronutrient composition. This is a qualitative questionnaires and not quantitative.
Time frame: evaluation of weight and body composition through study completion, an average of 4 months
Advanced glycation end products quantification
AGE levels will be measured using skin fluorescence, using the "AGE reader mu" device (range from 1.3 to 5 level of AGEs respect to the patient's age)
Time frame: evaluation of weight and body composition through study completion, an average of 4 months
Endogenous and exogenous AGEs plasma quantification
AGEs will also be assessed at the plasma level in free form (ELISA, fluorescence assay) or bound to hemoglobin (HbA1c clinical practice test), both measured in pg/mL
Time frame: evaluation of weight and body composition through study completion, an average of 4 months
Soluble RAGEs plasma quantification
RAGEs will also be assessed at the plasma level in solule form (ELISA) measured in pg/mL
Time frame: evaluation of weight and body composition through study completion, an average of 4 months