Prediabetes
Conditions
Keywords
prediabetes, type 2 diabetes, cardiovascular diseases
Brief 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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTProbiotic
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.
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose assessment with OGTT test and FGM | 4 months | Blood glucose and insulin tests at 0', 30', 60', 90', 120' minutes every 30 minutes Blood glucose monitoring at home |
| Pressure assessment | 4 months | Blood pressure is assessed during the visit at time 0 and after 60 days Filling out a blood pressure diary at home |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric measurements | evaluation of weight and body composition through study completion, an average of 4 months | Weight is assessed in Kg with the use of the bioimpedance balance. |
| Adherence level to the Western diet with European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaires | evaluation of weight and body composition through study completion, an average of 4 months | 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. |
| Adherence level to the Western diet with 24h recall questionnaires | evaluation of weight and body composition through study completion, an average of 4 months | 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. |
| Advanced glycation end products quantification | evaluation of weight and body composition through study completion, an average of 4 months | 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) |
| Endogenous and exogenous AGEs plasma quantification | evaluation of weight and body composition through study completion, an average of 4 months | 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 |
| Soluble RAGEs plasma quantification | evaluation of weight and body composition through study completion, an average of 4 months | RAGEs will also be assessed at the plasma level in solule form (ELISA) measured in pg/mL |
Countries
Italy
Contacts
CONTACTFlavia Prodam, MD PhD
PRINCIPAL_INVESTIGATORFlavia Prodam, MD PhD
AOU Maggiore della Carità
Outcome results
None listed