Sustainable Eating Pattern to Limit Malnutrition in Older Adults

NCT05860556 | Completed

• 2 other identifiers: 21042023CUP: F13C22001210007
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings, since malnutrition is highly prevalent, clinically relevant and potentially treatable condition. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT). The SENIOR CROSS-SECTIONAL study aims to map malnutrition status in accordance with the most recent GLIM criteria and investigate the association between malnutrition and anthropometric, demographic and socioeconomic, and lifestyle factors. In addition, sarcopenia will be diagnosed (EWGSOP2 consensus criteria) and blood markers will be measured. Malnutrition in Italian hospital setting is highly prevalent but the current malnutrition data prevalence and the general characteristics of older adults are not updated. Thus, it is expected to find a high malnutrition prevalence and an inadequate nutritional status.

Conditions

Malnutrition; Sarcopenia

Keywords

GLIM; older adults; prevalence; hospital; nutrition; risk factor; malnutrition; sarcopenia; sustainability

Outcome Measures

Primary Outcomes (1)

• Prevalence of malnutrition in free-living and hospitalized older adults

  Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool

  Day 1

Secondary Outcomes (23)

• Prevalence of sarcopenia in free-living and hospitalized older adults

  Day 1

• Level of physical activity in free-living and hospitalized older adults

  Day 1

• Activities of daily living

  Day 1

• Level of adherence to Mediterranean diet in free-living and hospitalized older adults

  Day 1

• Level of adherence to Mind Diet in free-living and hospitalized older adults

  Day 1

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults (over 65 years old), free-living or hospitalized, admitted at the hospitals

You may qualify if:

• Age ≥ 65 years old
• Admission to U.O. of General Medicine and to U.O.S.D. of Endocrinology and Metabolic diseases of ICS Maugeri IRCCS Hospital; to the Division and Specialist Gastroenterology Clinic of the IRCCS Policlinico San Matteo Foundation, Pavia, Italy; to the Department of Neurology and Geriatrics of the IRCCS San Gerardo dei Tintori Foundation, Monza, Italy
• Informed consent written and signed

You may not qualify if:

• Dysphagia
• Terminal disease
• History of bariatric surgery
• Dementia or cognitive decline (MMSE score \<20/30)
• Eating disorder
• Patients with tumor diagnosis not in remission and currently not treated with oncological therapy
• Advanced liver failure (CHILD ≥ B)
• Advanced renal failure (eGFR \< 15 mL/min/1.73m \^2 )
• Advanced chronic or acute respiratory failure (pO2 \< 60 mmHg or PCO2 \> 45 mmHg)

Sponsors & Collaborators

• University of Pavia: lead
• Fondazione Salvatore Maugeri: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Fondazione IRCCS San Gerardo dei Tintori: collaborator

Study Sites (1)

U.O. of General Medicine and U.O.S.D. of Endocrinology and Metabolic diseases of ICS Maugeri IRCCS Hospital, Pavia

Pavia, PV, 27100, Italy

Location

Related Publications (3)

• Coperchini F, Greco A, Teliti M, Croce L, Chytiris S, Magri F, Gaetano C, Rotondi M. Inflamm-ageing: How cytokines and nutrition shape the trajectory of ageing. Cytokine Growth Factor Rev. 2025 Apr;82:31-42. doi: 10.1016/j.cytogfr.2024.08.004. Epub 2024 Sep 2.

  PMID: 39237438 RESULT

• Madini N, Vincenti A, Beretta A, Santero S, Viroli G, Cena H. Addressing Inflammaging and Disease-Related Malnutrition: Adequacy of Oral Nutritional Supplements in Clinical Care. Nutrients. 2024 Nov 29;16(23):4141. doi: 10.3390/nu16234141.

  PMID: 39683535 RESULT

• Viroli G, Santero S, Madini N, Di Sabatino A, Donini LM, Magri F, Zuccotti GV, Calcaterra V, Giannetta E, Lenti MV, Masuelli L, Molfino A, Coperchini F, Daconto L, Di Napoli I, Lepore F, Spaziani M, Spinello Z, Mordà F, Vincenti A, Beretta A, Aronico N, Delliponti M, Mengoli C, Palumbo I, Rossi CM, Cena H. Onfoods spoke 6 projects: Tackling malnutrition. Clinical Nutrition ESPEN 63; 1234-1235. doi: 10.1016/j.clnesp.2024.07.811

  RESULT

Related Links

• Santero S, Madini N, Ricciardi Rizzo C, Viroli G, et al. Preliminary results of the SENIOR (sustainable eating pattern to limit malnutrition in older adults) project. Clin Nutr ESPEN, 69890. doi: 10.1016/j.clnesp.2025.07.220
• Viroli G, Bolpagni F, Madini N, Ricciardi Rizzo C, et al. Development of NutriA, a mobile application to enhance nutritional awareness in older adults. G Ital Med Lav Ergon \[Internet\]. 2026 Jan. 28;48(s1). doi: 10.4081/gimle.757
• Santero S, Viroli G, Sofroniou A, Madini N, et al. Effectiveness and cost-effectiveness of dietary protocols for malnourished older adults: a systematic review. PROSPERO 2024
• Santero S, Blagojevic B, Merzah M, Celada-Guerrero J, et al. Effect of fasting on muscle mass preservation in aging adults and older adults with or without a physical activity intervention: a scoping review. https://doi.org/10.17605/OSF.IO/3Y247

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Hellas Cena, Prof

  Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy; Istituti Clinici Scientifici Maugeri IRCCS, Unit of Clinical Nutrition, Pavia, Italy

  PRINCIPAL INVESTIGATOR

• Flavia Magri, Prof

  Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy; Unit of Endocrinology and Metabolism, Laboratory for Endocrine Disruptors, Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy

  PRINCIPAL INVESTIGATOR

• Antonio Di Sabatino, Prof

  Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy; First Department of Internal Medicine, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy

  PRINCIPAL INVESTIGATOR

• Maria Emilia Paladino, Dr

  Department of Medicine and Surgery, University of Milan-Bicocca, 20900 Monza, Italy; Department of Occupational Health, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro-Rector for Third Mission; Professor of Dietetics and Clinical Nutrition; Human Nutrition Researcher and Head of the Clinical Nutrition Laboratory

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: November 6, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

IT (1)