Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

NCT05853874 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-05

No results posted yet for this study

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 conditions. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT).

The SENIOR RCT aim to evaluate the efficacy of a 6 months nutrition protocol intervention compared to hospital standard care on malnourished older adults. Physical and nutritional status will be evaluated through anthropometric measures, blood exams and physical performance. In addition, the individual health perception will be evaluated.

It is expected to find an improvements of the physical and nutritional status.

Conditions

Interventions

OTHER

Nutrition intervention (dietary protocol)

The nutrition intervention sought to improve participants' overall diet quality, taking into account a sufficient intake of carbohydrates, lipids, fibres and micronutrients (vitamins and minerals), promoting proper fruits and vegetables consumption and variety. About water intake, considering the high dehydration risk in older persons highlighted by the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines, its adequate consumption is recommended and encouraged.

OTHER

Hospital standard of care

The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    collaborator OTHER
  • Fondazione IRCCS Policlinico San Matteo di Pavia

    collaborator OTHER
  • University of Pavia

    lead OTHER

Principal Investigators

  • Hellas Cena, Prof · Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia; Clinical Nutrition and Dietetics Service, Unit of Internal Medicine and Endocrinology, Pavia

  • Flavia Magri, Prof · Department of Internal Medicine and Therapeutics, University of Pavia and Istituti Clinici Scientifici Maugeri IRCCS, Unit of Internal Medicine and Endocrinology; Istituti Clinici Scientifici Maugeri IRCCS, Unit of Endocrinology and Metabolism, Pavia

  • Antonio Di Sabatino, Prof · Department of Internal Medicine and Therapeutics, University of Pavia; Fondazione IRCCS Policlinico San Matteo, Internal Medicine Unit, Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-01-31
Completion
2026-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853874 on ClinicalTrials.gov