An interventional study of Probiotic in Prediabetes, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Recruiting at 1 site in Italy. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Not applicable, Interventional, and Supportive care
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).
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 15 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a placebo for 60 days to allow comparison of the results with those observed in the intervention arm. Participants will take one placebo capsule once daily in the morning, on an empty stomach.
Dietary Supplement: Probiotic
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.
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
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
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
Plan to share: No
Ran from Jun 2025 to primary completion in Sep 2025, 3 months.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 3 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Probiotic
Azienda Ospedaliero Universitaria Maggiore della Carita