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

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.

Study Overview

• Status: Recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: Probiotic

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).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Flavia Prodam, MD PhD; Phone Number: +39-0321-660693; Email: flavia.prodam@med.uniupo.it

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • SCDU Endocrinology. AOU Ospedale Maggiore della Carità
    • Contact: Flavia MD Prodam, MD PhD; Phone Number: 0321660693; Email: flavia.prodam@med.uniupo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements	Weight is assessed in Kg with the use of the bioimpedance balance.	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	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	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.	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.	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.	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)	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	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	evaluation of weight and body composition through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Investigators: Principal Investigator: Flavia Prodam, MD PhD, AOU Maggiore della Carità

Publications and helpful links

General 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

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular diseases; type 2 diabetes; prediabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Prediabetic State; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: CE070/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No