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AzTrials

PrediabetesNutriAgeNCT07817290

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

A study testing Probiotic in people with Prediabetes, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Prediabetes
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
24 Jun 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Flavia Prodam, MD PhD contact

+39-0321-660693

flavia.prodam@med.uniupo.it

Italy1 site, 1 recruiting

  • SCDU Endocrinology. AOU Ospedale Maggiore della Carità

    Novara, 28100

    Flavia MD Prodam, MD PhD, 0321660693, flavia.prodam@med.uniupo.it

    Recruiting

Other trials in Italy

About this study

Official title: NUTRI.AGE: DEVELOPMENT OF SMART FOOD/NUTRACEUTICAL SOLUTIONS DEDICATED TO CARDIOMETABOLIC DISORDERS IN AGEING

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.

Read the 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).

Conditions
Prediabetes
Being tested
Probiotic
Keywords
prediabetes, type 2 diabetes, cardiovascular diseases
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticDietary 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.

Study groups in NCT07817290
Study groupRoleWhat they receive
PlaceboExperimentalParticipants 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.
Receives: Dietary Supplement: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 4 months

Secondary outcomes (9)

  1. Anthropometric measurements

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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: evaluation of weight and body composition through study completion, an average of 4 months

  5. 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.

    Measured: evaluation of weight and body composition through study completion, an average of 4 months

  6. 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.

    Measured: evaluation of weight and body composition through study completion, an average of 4 months

  7. 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)

    Measured: evaluation of weight and body composition through study completion, an average of 4 months

  8. 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

    Measured: evaluation of weight and body composition through study completion, an average of 4 months

  9. Soluble RAGEs plasma quantification

    RAGEs will also be assessed at the plasma level in solule form (ELISA) measured in pg/mL

    Measured: evaluation of weight and body composition through study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start24 Jun 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07817290
Sponsor's protocol ID
CE070/2025
Acronym
NutriAge
Status last verified
Sep 2026
First submitted
7 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • [1] Vadim N. GladyshevAging: progressive decline in fitness due to the rising deleteriome adjusted by genetic, environmental, and stochastic processes,06 April 2016 https://doi.org/10.1111/acel.12480. [2] Guo, J., Huang, X., Dou, L. et al. Aging and aging-related diseases: from molecular mechanisms to interventions and treatments. Sig Transduct Target Ther 7, 391 (2022). https://doi.org/10.1038/s41392-022-01251-0. [3] http://dati-anziani.istat.it/Index.aspx [4] https://www.salute.gov.it/portale/documentazione/p6_2_2_1.jsp?id=3074 [5] Ilse Bloom, Mark Edwards, Karen A. Jameson, Holly E. Syddall, Elaine Dennison, Catharine R. Gale, Janis Baird, Cyrus Cooper, Avan Aihie Sayer, Sian Robinson, Influences on diet quality in older age: the importance of social factors, Age and Ageing, Volume 46, Issue 2, March 2017, Pages 277-283, https://doi.org/10.1093/ageing/afw180 [6] https://doi.org/10.1093/ageing/afw180Ragonnaud, E., Biragyn, A. Gut microbiota as the key controllers of "healthy" aging of elderly people. Immun Ageing 18, 2 (2021). https://doi.org/10.1186/s12979-020-00213-w [7] Nuria Salazar, Lorena Valdés-Varela, Sonia González, Miguel Gueimonde & Clara G. de los Reyes-Gavilán (2017) Nutrition and the gut microbiome in the elderly, Gut Microbes, 8:2, 82- 97, DOI: 10.1080/19490976.2016.1256525 [8] Białecka-Dębek, A.; Granda, D.; Szmidt, M.K.; Zielińska, D. Gut Microbiota, Probiotic Interventions, and Cognitive Function in the Elderly: A Review of Current Knowledge. Nutrients 2021, 13, 2514. https://doi.org/10.3390/nu13082514 [9] Hutchinson, A.N.; Bergh, C.; Kruger, K.; Sűsserová, M.; Allen, J.; Améen, S.; Tingö, L. The Effect of Probiotics on Health Outcomes in the Elderly: A Systematic Review of Randomized, Placebo-Controlled Studies. Microorganisms 2021, 9, 1344. https://doi.org/10.3390/microorganisms9061344 [10] ALE, Elisa C.; BINETTI, Ana G. Role of probiotics, prebiotics, and synbiotics in the elderly: insights into their applications. Frontiers in Microbiology, 2021, 12: 631254. [11] Wu, H.; Chiou, J. Potential Benefits of Probiotics and Prebiotics for Coronary Heart Disease and Stroke. Nutrients 2021, 13, 2878. https://doi.org/10.3390/nu13082878 [12] Kiersnowska K, Jakubczyk A. Bioactive Peptides Obtained from Legume Seeds as New Compounds in Metabolic Syndrome Prevention and Diet Therapy. Foods. 2022 Oct 21;11(20):3300. doi: 10.3390/foods11203300. PMID: 37431048; PMCID: PMC9602117. [13] Alexander R, Khaja A, Debiec N, Fazioli A, Torrance M, Razzaque MS. Health-promoting benefits of lentils: Anti-inflammatory and anti-microbial effects. Curr Res Physiol. 2024 Mar 5;7:100124. doi: 10.1016/j.crphys.2024.100124. PMID: 38501131; PMCID: PMC10945126. [14] Rezvankhah A, Yarmand MS, Ghanbarzadeh B, Mirzaee H. Development of lentil peptides with potent antioxidant, antihypertensive, and antidiabetic activities along with umami taste. Food Sci Nutr. 2023 Feb 27;11(6):2974-2989. doi: 10.1002/fsn3.3279. PMID: 37324857; PMCID: PMC10261806. [15] Nicola Faccilongo, Giustina Pellegrini, Piermichele La Sala, Economia circolare e scarti nelle filiere agroalimentari: prima indagine esplorativa sullo stato dell'arte, in

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Prediabetes, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Flavia Prodam, MD PhD (+39-0321-660693, flavia.prodam@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood glucose assessment with OGTT test and FGM (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07817290, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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