Sustainable Eating Pattern to Limit Malnutrition in Older Adults (NCT05860556) | Clinical Trial Compass
CompletedNot Applicable
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Italy303 participantsStarted 2023-11-06
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 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.
Who can participate
Age range
65 Years – 120 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 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
Exclusion Criteria:
* 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)
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
1
Prevalence of malnutrition in free-living and hospitalized older adults