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

NCT07817290 | Recruiting

• 1 other identifier: CE070/2025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Keywords

prediabetes; type 2 diabetes; cardiovascular diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Anthropometric measurements

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

• Anthropometric measurements

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

• Anthropometric measurements

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

• Anthropometric measurements

  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

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

Study Arms (1)

Placebo

EXPERIMENTAL

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

Interventions

Probiotic DIETARY_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.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

SCDU Endocrinology. AOU Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (1)

• [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

  BACKGROUND

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MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Flavia Prodam, MD PhD

  AOU Maggiore della Carità

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavia Prodam, MD PhD

CONTACT

+39-0321-660693; flavia.prodam@med.uniupo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 14, 2026
• Study Start: June 24, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)