WithdrawnNot Applicable

Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

Stopped: The RCT phase was not started due to delays in obtaining the approval by the reference Ethics Committees, logistical difficulties in starting recruitment, and low number of eligible participants.

0Started 2024-01

Plain-language 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.

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT05853874

SponsorUniversity of Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Malnutrition trials

Plain-language summary

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

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