Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

NCT05853874 | Withdrawn

• 2 other identifiers: 22042023CUP: F13C22001210007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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

Malnutrition; Sarcopenia

Keywords

Nutrition intervention; older adults; malnutrition; sustainability; 24-h recall; sarcopenia; nutritional protocol

Outcome Measures

Primary Outcomes (2)

• Change in nutritional status pre- and post- intervention between experimental and control group measuring weight

  Weight gain= + 2kg

  24 months (baseline, 3 months, 6 months and 12 months)

• Change in nutritional status pre- and post- intervention between experimental and control group measuring strength

  Increase in strength = + 1 kg

  24 months (baseline, 3 months, 6 months and 12 months)

Secondary Outcomes (24)

• Changes pre- and post- intervention between experimental and control groups for complete blood count

  24 months (baseline and 6 months)

• Changes pre- and post- intervention between experimental and control groups for blood lipid profile

  24 months (baseline and 6 months)

• Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)

  24 months (baseline and 6 months)

• Changes pre- and post- intervention between experimental and control groups for blood transaminases

  24 months (baseline and 6 months)

• Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase

  24 months (baseline and 6 months)

Study Arms (2)

Nutritional intervention

EXPERIMENTAL

Nutritional intervention consist in a macro- and micronutrients balanced nutritional protocol with a focus on sustainability and personalized according to the individual malnutrition severity. In particular, an adequate coverage of energy, protein and water requirements will be guaranteed according to Italian reference values (LARN) and European (ESPEN) guidelines. In light of the scientific literature and the principal issues founding in malnourished older people, the proposed nutritional protocol will provide an adequate and sustainable consumption of animal and vegetable proteins and an appropriate water intake. The nutritional intervention will be carried out by a qualified staff.

Other: Nutrition intervention (dietary protocol)

Control

OTHER

The control group receive the standard of care provided for malnutrition treatment by hospitals

Other: Hospital standard of care

Interventions

Nutrition intervention (dietary protocol) OTHER

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.

Nutritional intervention

Hospital standard of care OTHER

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

Control

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years old
• Admission to two Scientific Hospitalization and Treatment Institutions in Pavia, Italy
• Informed consent written and signed
• Malnutrition (GLIM diagnosis)

You may not qualify if:

• Dysphagia
• Prior nutritional medical treatment
• Terminal disease
• History of gastric bypass, anorexia nervosa, liver failure
• Dementia or severe confusion (MMSE score\<24/30)
• Patients with tumor diagnosis not in remission and currently not treated with oncological therapy
• Patients with chronic or acute respiratory failure
• Barthel index score \< 70/100

Sponsors & Collaborators

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

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Interventions

Diet Therapy

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

• Antonio Di Sabatino, Prof

  Department of Internal Medicine and Therapeutics, University of Pavia; Fondazione IRCCS Policlinico San Matteo, Internal Medicine Unit, Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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

Model Details: Randomized Control Trial with two parallel arms. The intervention group will receive a nutritional protocol and the control group will receive the standard of care

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 11, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04