Smart probiotic and nutraceutical approach for cardiometabolic health in older adults
Official title: NUTRI.AGE: DEVELOPMENT OF SMART FOOD/NUTRACEUTICAL SOLUTIONS DEDICATED TO CARDIOMETABOLIC DISORDERS IN AGEING
Run by Azienda Ospedaliero Universitaria Maggiore della Carita · NCT07817290 · Data updated 2026-11-12
This trial tests whether a probiotic-containing nutraceutical strategy can improve metabolic health and blood pressure in adults over 65 with prediabetes or cardiovascular disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara) |
| Status | Recruiting |
| Started | June 24, 2025 |
| Main results expected | September 30, 2025 |
| Study ends | November 30, 2026 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT07817290 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men and women aged 65 or older with known cardiovascular disease and prediabetes or type 2 diabetes (HbA1c < 7.0% on diet alone or metformin).
✕Probably not a fit
Individuals under 65, those on certain diabetes therapies beyond metformin, or with conditions contraindicating probiotic or nutraceutical use may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study explores in humans whether formulated probiotic-based food supplements with bioactive components can influence metabolic status and the renin-angiotensin-aldosterone system in older adults with cardiometabolic disorders. The approach combines enhanced bioactive compounds and selected probiotics to potentially improve blood pressure, metabolic markers, and overall well-being. Participants will undergo assessments of body composition, blood chemistry, blood glucose monitoring, and dietary habits before and after taking the probiotic formulation. The study targets older adults with prediabetes or type 2 diabetes and established cardiovascular disease, aiming to determine in vivo effects and feasibility of the nutraceutical strategy. The trial is conducted at a single institution under the coordination of the Maggiore della Carità hospital in Novara, Italy.
Why it matters
Potential benefit: If successful, participants might experience improved blood pressure control and better metabolic health through a probiotic-nutraceutical approach.
How similar studies have gone: Previous research has shown metabolic and blood pressure effects with probiotics and bioactive compounds in related populations, but this specific combined nutraceutical strategy in older adults with cardiometabolic disease is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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SCDU Endocrinology. AOU Ospedale Maggiore della Carità
Novara, Italy Recruiting
Study contacts
- Principal investigator: Flavia Prodam, MD PhD — AOU Maggiore della Carità
- Study coordinator: Flavia Prodam, MD PhD
- Email: flavia.prodam@med.uniupo.it
- Phone: +39-0321-660693
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.