Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults (SENIOR)

Sustainable Eating Pattern to Limit Malnutrition in Older Adults

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.

Study Overview

• Status: Withdrawn
• Conditions: Malnutrition; Sarcopenia
• Intervention / Treatment: Other: Nutrition intervention (dietary protocol); Other: Hospital standard of care

Detailed Description

The SENIOR RCT is a multicenter study conducted in two North Italian Scientific Hospitalization and Treatment Institution in Pavia on older malnourished adults (≥ 65 years old). The estimated duration is 24 months, which include 6 months of nutritional intervention and a follow-up after 6 months, with an preferred starting date on January 2024.

The primary objective of the SENIOR RCT is the evaluation of the efficacy of a 6 months sustainable nutrition protocol on malnourished older adults participants (diagnosed with the most recent GLIM criteria) in comparison to the hospital standard of care.

Therefore, the primary endpoint is the improvement of the nutritional status between pre- and post-intervention between experimental and control group measuring the change of body weight and strength (handgrip).

Secondary objectives are the change pre- and post-intervention between experimental and control group for blood biomarkers, dietary habits, quality of life and evaluation of sarcopenia.

Secondary endpoints are the change pre- and post-intervention between experimental and control group for blood biomarkers, MEDI-LITE score, SF-12, diet composition, phase angle and gait speed.

Participants of this study are older adults over 65 previously enrolled in the SENIOR cross-sectional study and willing to participate to the RCT phase or new enrolled patients from the two hospitals in according to the eligible criteria. Malnutrition will be diagnosed according to GLIM criteria, using Malnutrition Universal Screening Tool (MUST) as screening tool.

The experimental group at the baseline will receive a nutritional assessment followed by the elaboration of a sustainable and personalized nutritional protocol by qualified dietitians. The intervention will last 6 months with a monthly evaluation of the dietary consumption of the previous 24 hour (recall-24h), followed by a final follow-up after additional 6 months.

For both groups at the baseline will be measured blood biomarkers, anthropometric variables, Mediterranean diet adherence, quality of life, strength (handgrip) and locomotion (gait speed). At 3 months weight and strength will be evaluated. At 6- and 12-months baseline measurements will be repeated except for the nutritional assessment.

Dietary habits will be evaluated through a Mediterranean diet questionnaire (MEDI-LITE), while quality of life will be measured with Short-Form Health Survey (SF-12) questionnaire. Anthropometric variables include weight, height (knee height and demi-span), waist circumference, and body composition (BIA). In addition, strength (handgrip) and locomotion (gait speed) will be evaluated. Strength (handgrip), Appendicular Skeletal Mass (ASM) and locomotion (gait speed) are necessary to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) consensus. Malnutrition will be evaluated again at 6 months.

Blood analysis will be carried out on a subgroup to evaluate the participants' inflammatory, nutritional and clinical status.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional intervention; 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); 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: Control; The control group receive the standard of care provided for malnutrition treatment by hospitals	Other: Hospital standard of care; The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes pre- and post- intervention between experimental and control groups for complete blood count	Red blood cells (10^9/L), white blood cells (10^12/L or %), hemoglobin (g/dl), hematocrit (%), platelets (10^9/L).	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood lipid profile	low density lipoprotein (mmol/l), high density lipoprotein (mg/dl), total colesterol (mg/dl), triglicerydes (mg/dl)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)	C reactive Protein (CRP) (mg/dl)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood transaminases	(glutamic oxaloacetic transaminase, Glutamic-Pyruvic Transaminase, gamma-glutamyl transferase) (U/I) Alkaline phosphatase (U/L)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase	Creatin Kinase (UI/L)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood prealbumin	prealbumin (g/mL)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood cytokine	interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α, transforming tumor factor-β (pg/ml)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for glycemia.	glycemia (mg/dl)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood insulin	Insulin (µU/mL)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood homocysteine	Homocysteine (µmol/L)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood vitamine D	vitamine D (ng/ml)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood vitamine B12	vitamine 12 (pg/ml)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood vitamine B9	vitamine 9 (ng/mL)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)	Na (mmol/L)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood potassium (K)	K (mEq/l)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)	Mg (mEq/l)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)	Ca (mg/dL)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)	Fe (μg)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)	Zn (mmol/l)	24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for adherence to Mediterranean Diet	Medi-Lite adherence score.score ranges between 0-18. A high score represents a higher adherence to Mediterranean diet.	24 months (baseline, 6 months and 12 months)
Changes pre- and post- intervention between experimental and control groups for the quality of life	Short-Form Health Survey 12. Total score ranges between 0-100. A higher score represents a better quality of life	24 months (baseline, 6 months and 12 months)
Changes pre- and post- intervention between experimental and control groups for the dietary nutritional composition	Improvements of dietary composition evaluated with monthly 24-h recalls	24 months (baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months)
Changes pre- and post- intervention between experimental and control groups of fat free mass	Improvement of the phase angle (θ) measured by bioimpedance analysis	24 months (baseline, 6 months and 12 months)
Changes pre- and post- intervention between experimental and control groups in locomotion test	Velocity walking increase measured with gait speed test	24 months (baseline, 6 months and 12 months)

Collaborators and Investigators

• Sponsor: University of Pavia
• Collaborators: Fondazione Salvatore Maugeri; Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: older adults; sarcopenia; malnutrition; Nutrition intervention; sustainability; 24-h recall; nutritional protocol
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Sarcopenia; Therapeutics; Nutrition Therapy; Diet Therapy
• Other Study ID Numbers: 22042023; CUP: F13C22001210007 (Other Grant/Funding Number: PNRR - MUR)

Drug and device information, study documents

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