MalnutritionSENIORNCT05860556
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
An observational study of Malnutrition and Sarcopenia, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Sarcopenia
- How many people
- 303 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adults (over 65 years old), free-living or hospitalized, admitted at the hospitals
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. of General Medicine and U.O.S.D. of Endocrinology and Metabolic diseases of ICS Maugeri IRCCS Hospital, Pavia
Pavia, PV, 27100
About this study
Official title: Sustainable Eating Pattern to Limit Malnutrition in Older Adults (SENIOR)
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.
Read the detailed description
The SENIOR cross-sectional study is a multicenter study conducted in three North Italian Scientific Hospitalization and Treatment Institutions in Pavia and Monza on older adults (≥ 65 years old). The estimated duration is 36 months with an preferred starting date on November 2023.
The primary objective of the SENIOR cross-sectional is the evaluation of the nutritional status in at least a total of 200 free-living and hospitalized older adults. Therefore, the primary endpoint is to define the malnutrition prevalence in free-living and hospitalized older adults with GLIM criteria, which is the most update recent international consent.
As secondary objectives, the definition of the prevalence of sarcopenia (according to EWGSOP2 diagnosis) and a mapping of other relevant factors potentially associated with malnutrition will be carried out on the population target: lifestyle, socioeconomic status, anthropometric measures, clinical condition including medical treatment and blood analysis. In addition, the impact of these factors on health status of the target population will be investigated, potentially leading to the identification of new malnutrition risk factors.
To the over 65 older adults, admitted at the three hospitals for medical visits or recovery, will be proposed to participate to the SENIOR cross-sectional study. After the participants' signature of the informed consent, the clinical and pathological information will be gathered to assess the eligibility.
On eligible subject different variables will be measured. Dietary habits will be evaluated through a Mediterranean diet questionnaire (MEDI-LITE) and the MIND diet questionnaire. Physical activity will be evaluated with the Physical Activity Scale for the Elderly (PASE) questionnaire and activities of daily living will be assessed through Barthel Index. Sleep quality will be investigated with Pittsburgh questionnaire. Emotional status of participants will be examined with the Geriatric Depression Scale 15 item (GDS-15). Quality of life will be measured with SF-12 questionnaire. Ending, vitamin D deficiency will be evaluated with the Evidence Q questionnaire.
Anthropometric variables will include weight, height (knee height and demi-span), circumferences (waist, mid-arm, calf and medium tight), and body composition (bioimpedance analysis, BIA). In addition, muscle strength (handgrip) and physical performance (4-meter gait speed) will be evaluated.
Malnutrition will be diagnosed according to the 2019 GLIM criteria using a two-step approach. Participants will be first screened with Malnutrition Universal Screening Tool (MUST), followed by diagnostic assessment requiring at least one phenotypic criterion (weight loss, low BMI, or reduced appendicular skeletal muscle mass derived from BIA) and one etiologic criterion (reduced intake or inflammation/disease burden). Severity grading will be also performed.
Muscle strength (handgrip), Appendicular Skeletal Mass (ASM, derived from BIA) and locomotion (gait speed) will be used to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) consensus.
Intrinsic capacity, a marker of healthy aging promoted by the World Health Organisation (WHO), will be also assessed, exploring the following domains: locomotion, vitality, cognition, psychological status, and sensory function.
Blood analysis will be carried out on a subgroup to evaluate the participants' inflammatory, nutritional and clinical status.
Data from medical records will be used to calculate the Cumulative Illness Rating Scale (CIRS) score, a gold-standard measure of overall disease burden. The CIRS-based comorbidity and severity indices quantify an individual's health status, with lower scores indicating lower burden and higher scores indicating greater severity and comorbidity.
Finally, information on medication use at hospital admission (number and active substances) and hospitalizations in the previous year (yes/no) will be retrieved from medical records, based on prior structured interviews. Length of stay will be obtained from discharge letters and defined as the number of days spent in the hospital for each inpatient.
- Conditions
- Malnutrition, Sarcopenia
- Keywords
- GLIM, older adults, prevalence, hospital, nutrition, risk factor, malnutrition, sarcopenia, sustainability
- Medical subject headings
- Malnutrition, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malnutrition in free-living and hospitalized older adults
Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool
Measured: Day 1
Secondary outcomes (23)
Prevalence of sarcopenia in free-living and hospitalized older adults
Sarcopenia diagnosis (EWGSOP2)
Measured: Day 1
Level of physical activity in free-living and hospitalized older adults
Physical Activity Scale for the Elderly questionnaire. Total score ranges from 0 to 450 and an higher score represents a higher level of physical activity.
OR Barthel Index. The total score ranges from 0 to 100. The lower score indicates a totally dependent and a higher score indicates a higher independence in daily activities
Measured: Day 1
Activities of daily living
Barthel Index. The total score ranges from 0 to 100. The lower score indicates a totally dependency and a higher score indicates a higher independence in daily activities.
Measured: Day 1
Level of adherence to Mediterranean diet in free-living and hospitalized older adults
Medi-Lite adherence score questionnaire. Total score ranges between 0-18. A high score represents a higher adherence to Mediterranean diet
Measured: Day 1
Level of adherence to Mind Diet in free-living and hospitalized older adults
Mind diet score. Total score ranges from 0 to 15. A higher score indicate a higher adherence to Mind Diet
Measured: Day 1
Sleep quality in free-living and hospitalized older adults
pittsburgh sleep quality index. Total score ranges between 0-21. A higher score represents higher sleep difficulties
Measured: Day 1
Level of quality of life in free-living and hospitalized older adults
Short-Form Health Survey 12. Total score ranges between 0-100. A higher score represents a better quality of life
Measured: Day 1
Level of intrinsic capacity in free-living and hospitalized older adults
The scores of the following domains will be summarized to calculate the intrinsic capacity total score, which ranges from 0 to 10. A higher score represents a higher intrinsic capacity:
- Locomotion (4-m gait speed) (m/s); score ranges between 0-2
- Vitality (malnutrition according to GLIM criteria); score ranges between 0-2
- Cognition (Mini Mental State Examination); score ranges between 0-2
- Psychological state (Geriatric Depression Scale 15 items); score ranges between 0-2
- Sensory function (vision and hearing): score ranges between 0-2
Measured: Day 1
Level of depression in free-living and hospitalized older adults
Geriatric Depression Scale. Total score ranges between 0-15. A higher score represents higher depression status
Measured: Day 1
Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults
Biomarkers blood measured from fasting blood samples are:
Complete blood count with leukocyte count (Red blood cell count (10 ^12 /l), White blood cell count (10 ^9 /l), Pateletes (10 ^9 /l), Hemoglobine (g/l), haematocrit (%), prothrombin/INR (sec)); Lipid profile (Low density lipoprotein, high density lipoprotein, total cholesterol, triglycerides) (mg/dl); Uric acid (mg/dl); C reactive Protein (CRP) (mg/dl) Plasmatic creatinine (mg/dl) Transaminases (glutamic oxaloacetic transaminase, Glutamic-Pyruvic Transaminase, gamma-glutamyl transferase) (U/I) Alkaline phosphatase (U/L) Creatin Kinase (UI/L) Prealbumin (g/mL) Cytokine (interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α, transforming tumor factor-β) (pg/ml) Glycemia (mg/dl) Insulin (µU/mL) Homocysteine (µmol/L) Vitamines (D (ng/ml), B12 (pg/ml), B9 (ng/ml)) Minerals (Na (mmol/L), K (mmol/L), Mg (mg/dl), Ca (mg/dl), Fe (µg/dl), Zn (mg/dl))
Measured: Day 1
Socio-demographic characteristic in free-living and hospitalized older adults
Structured interview (sex, age, ethnicity, marital status, level of education, socioeconomic status, e.g. household, occupation, residential area, people in the house, and social support)
Measured: Day 1
Vitamin D deficiency in free-living and hospitalized older adults
Evaluation Vitamin D dEficieNCy Questionnaire (EVIDENCe-Q). Total range from 0 (better status) to 36 (worsen status).
Measured: Day 1
Body Mass Index (BMI) in free-living and hospitalized older adults
Weight (kg) with a calibrated weighing scale; height derived by demi-span (cm) through validated equation. Weight and height derived by demi-span will be combined to report BMI in kg/m^2)
Measured: Day 1
Height derived by knee height in free-living and hospitalized older adults
Height derived by knee height (cm) through validated equation.
Measured: Day 1
Referred height in free-living and hospitalized older adults
Referred height (cm) with a structured question
Measured: Day 1
Waist circumference in free-living and hospitalized older adults
Waist circumference (cm) through an anelastic tape.
Measured: Day 1
Mid-arm circumference in free-living and hospitalized older adults
Mid-arm circumference (cm) through an anelastic tape.
Measured: Day 1
Calf circumference in free-living and hospitalized older adults
Calf circumference (cm) through an anelastic tape.
Measured: Day 1
Mid-thigh circumference in free-living and hospitalized older adults
Mid-thigh circumference (cm) measured with an anelastic tape
Measured: Day 1
Fat-Free Mass (FFM) in free-living and hospitalized older adults
Fat-Free Mass (FFM, KG) measured by Bioelectrical Impedance Analysis (BIA)
Measured: Day 1
Fat Mass (FM) in free-living and hospitalized older adults
Fat Mass (FM, kg) measured by Bioelectrical Impedance Analysis (BIA)
Measured: Day 1
Body Water in free-living and hospitalized older adults
Total Body Water (TBW, l), Extracellular Water (ECW, l) and Intracellular Water (ICW, l) measured by Bioelectrical Impedance Analysis (BIA)
Measured: Day 1
Phase angle in free-living and hospitalized older adults
Phase angle (θ) measured by Bioelectrical Impedance Analysis (BIA)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start6 Nov 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione IRCCS San Gerardo dei Tintori, Fondazione Salvatore Maugeri
- Responsible party
- Principal investigator, Hellas Cena, University of Pavia
- Investigators
- Hellas Cena, Prof, Principal investigator, Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy; Istituti Clinici Scientifici Maugeri IRCCS, Unit of Clinical Nutrition, Pavia, ItalyFlavia Magri, Prof, Principal investigator, Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy; Unit of Endocrinology and Metabolism, Laboratory for Endocrine Disruptors, Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, ItalyAntonio Di Sabatino, Prof, Principal investigator, Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy; First Department of Internal Medicine, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, ItalyMaria Emilia Paladino, Dr, Principal investigator, Department of Medicine and Surgery, University of Milan-Bicocca, 20900 Monza, Italy; Department of Occupational Health, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860556
- Sponsor's protocol ID
- 21042023
- Other IDs
- CUP: F13C22001210007
- Acronym
- SENIOR
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2023
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coperchini F, Greco A, Teliti M, Croce L, Chytiris S, Magri F, Gaetano C, Rotondi M. Inflamm-ageing: How cytokines and nutrition shape the trajectory of ageing. Cytokine Growth Factor Rev. 2025 Apr;82:31-42. doi: 10.1016/j.cytogfr.2024.08.004. Epub 2024 Sep 2.
PubMed 39237438Madini N, Vincenti A, Beretta A, Santero S, Viroli G, Cena H. Addressing Inflammaging and Disease-Related Malnutrition: Adequacy of Oral Nutritional Supplements in Clinical Care. Nutrients. 2024 Nov 29;16(23):4141. doi: 10.3390/nu16234141.
PubMed 39683535Viroli G, Santero S, Madini N, Di Sabatino A, Donini LM, Magri F, Zuccotti GV, Calcaterra V, Giannetta E, Lenti MV, Masuelli L, Molfino A, Coperchini F, Daconto L, Di Napoli I, Lepore F, Spaziani M, Spinello Z, Mordà F, Vincenti A, Beretta A, Aronico N, Delliponti M, Mengoli C, Palumbo I, Rossi CM, Cena H. Onfoods spoke 6 projects: Tackling malnutrition. Clinical Nutrition ESPEN 63; 1234-1235. doi: 10.1016/j.clnesp.2024.07.811
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Eating Pattern to Limit Malnutrition in Older Adults (SENIOR)
- ClinicalTrials.gov ID
- NCT05860556
- Acronym / sponsor ID
- SENIOR / 21042023
- Conditions
- Malnutrition, Sarcopenia
- Keywords
- GLIM, older adults, prevalence, hospital, nutrition, risk factor, malnutrition, sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione IRCCS San Gerardo dei Tintori, Fondazione Salvatore Maugeri
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The SENIOR cross-sectional study is a multicenter study conducted in three North Italian Scientific Hospitalization and Treatment Institutions in Pavia and Monza on older adults (≥ 65 years old). The estimated duration is 36 months with an preferred starting date on November 2023.
The primary objective of the SENIOR cross-sectional is the evaluation of the nutritional status in at least a total of 200 free-living and hospitalized older adults. Therefore, the primary endpoint is to define the malnutrition prevalence in free-living and hospitalized older adults with GLIM criteria, which is the most update recent international consent.
As secondary objectives, the definition of the prevalence of sarcopenia (according to EWGSOP2 diagnosis) and a mapping of other relevant factors potentially associated with malnutrition will be carried out on the population target: lifestyle, socioeconomic status, anthropometric measures, clinical condition including medical treatment and blood analysis. In addition, the impact of these factors on health status of the target population will be investigated, potentially leading to the identification of new malnutrition risk factors.
To the over 65 older adults, admitted at the three hospitals for medical visits or recovery, will be proposed to participate to the SENIOR cross-sectional study. After the participants' signature of the informed consent, the clinical and pathological information will be gathered to assess the eligibility.
On eligible subject different variables will be measured. Dietary habits will be evaluated through a Mediterranean diet questionnaire (MEDI-LITE) and the MIND diet questionnaire. Physical activity will be evaluated with the Physical Activity Scale for the Elderly (PASE) questionnaire and activities of daily living will be assessed through Barthel Index. Sleep quality will be investigated with Pittsburgh questionnaire. Emotional status of participants will be examined with the Geriatric Depression Scale 15 item (GDS-15). Quality of life will be measured with SF-12 questionnaire. Ending, vitamin D deficiency will be evaluated with the Evidence Q questionnaire.
Anthropometric variables will include weight, height (knee height and demi-span), circumferences (waist, mid-arm, calf and medium tight), and body composition (bioimpedance analysis, BIA). In addition, muscle strength (handgrip) and physical performance (4-meter gait speed) will be evaluated.
Malnutrition will be diagnosed according to the 2019 GLIM criteria using a two-step approach. Participants will be first screened with Malnutrition Universal Screening Tool (MUST), followed by diagnostic assessment requiring at least one phenotypic criterion (weight loss, low BMI, or reduced appendicular skeletal muscle mass derived from BIA) and one etiologic criterion (reduced intake or inflammation/disease burden). Severity grading will be also performed.
Muscle strength (handgrip), Appendicular Skeletal Mass (ASM, derived from BIA) and locomotion (gait speed) will be used to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) consensus.
Intrinsic capacity, a marker of healthy aging promoted by the World Health Organisation (WHO), will be also assessed, exploring the following domains: locomotion, vitality, cognition, psychological status, and sensory function.
Blood analysis will be carried out on a subgroup to evaluate the participants' inflammatory, nutritional and clinical status.
Data from medical records will be used to calculate the Cumulative Illness Rating Scale (CIRS) score, a gold-standard measure of overall disease burden. The CIRS-based comorbidity and severity indices quantify an individual's health status, with lower scores indicating lower burden and higher scores indicating greater severity and comorbidity.
Finally, information on medication use at hospital admission (number and active substances) and hospitalizations in the previous year (yes/no) will be retrieved from medical records, based on prior structured interviews. Length of stay will be obtained from discharge letters and defined as the number of days spent in the hospital for each inpatient.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults (over 65 years old), free-living or hospitalized, admitted at the hospitals
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Dysphagia
- Terminal disease
- History of bariatric surgery
- Dementia or cognitive decline (MMSE score <20/30)
- Eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of malnutrition in free-living and hospitalized older adults
Time frame: Day 1
Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool
23 secondary outcomes
Prevalence of sarcopenia in free-living and hospitalized older adults
Time frame: Day 1
Level of physical activity in free-living and hospitalized older adults
Time frame: Day 1
Activities of daily living
Time frame: Day 1
Level of adherence to Mediterranean diet in free-living and hospitalized older adults
Time frame: Day 1
Level of adherence to Mind Diet in free-living and hospitalized older adults
Time frame: Day 1
Sleep quality in free-living and hospitalized older adults
Time frame: Day 1
Level of quality of life in free-living and hospitalized older adults
Time frame: Day 1
Level of intrinsic capacity in free-living and hospitalized older adults
Time frame: Day 1
Level of depression in free-living and hospitalized older adults
Time frame: Day 1
Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults
Time frame: Day 1
Socio-demographic characteristic in free-living and hospitalized older adults
Time frame: Day 1
Vitamin D deficiency in free-living and hospitalized older adults
Time frame: Day 1
Body Mass Index (BMI) in free-living and hospitalized older adults
Time frame: Day 1
Height derived by knee height in free-living and hospitalized older adults
Time frame: Day 1
Referred height in free-living and hospitalized older adults
Time frame: Day 1
Waist circumference in free-living and hospitalized older adults
Time frame: Day 1
Mid-arm circumference in free-living and hospitalized older adults
Time frame: Day 1
Calf circumference in free-living and hospitalized older adults
Time frame: Day 1
Mid-thigh circumference in free-living and hospitalized older adults
Time frame: Day 1
Fat-Free Mass (FFM) in free-living and hospitalized older adults
Time frame: Day 1
Fat Mass (FM) in free-living and hospitalized older adults
Time frame: Day 1
Body Water in free-living and hospitalized older adults
Time frame: Day 1
Phase angle in free-living and hospitalized older adults
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 39237438Coperchini F, Greco A, Teliti M, Croce L, Chytiris S, Magri F, Gaetano C, Rotondi M. Inflamm-ageing: How cytokines and nutrition shape the trajectory of ageing. Cytokine Growth Factor Rev. 2025 Apr;82:31-42. doi: 10.1016/j.cytogfr.2024.08.004. Epub 2024 Sep 2.
- Results publication: PubMed 39683535Madini N, Vincenti A, Beretta A, Santero S, Viroli G, Cena H. Addressing Inflammaging and Disease-Related Malnutrition: Adequacy of Oral Nutritional Supplements in Clinical Care. Nutrients. 2024 Nov 29;16(23):4141. doi: 10.3390/nu16234141.
- Results publicationViroli G, Santero S, Madini N, Di Sabatino A, Donini LM, Magri F, Zuccotti GV, Calcaterra V, Giannetta E, Lenti MV, Masuelli L, Molfino A, Coperchini F, Daconto L, Di Napoli I, Lepore F, Spaziani M, Spinello Z, Mordà F, Vincenti A, Beretta A, Aronico N, Delliponti M, Mengoli C, Palumbo I, Rossi CM, Cena H. Onfoods spoke 6 projects: Tackling malnutrition. Clinical Nutrition ESPEN 63; 1234-1235. doi: 10.1016/j.clnesp.2024.07.811
- Viroli G, Bolpagni F, Madini N, Ricciardi Rizzo C, et al. Development of NutriA, a mobile application to enhance nutritional awareness in older adults. G Ital Med Lav Ergon \[Internet\]. 2026 Jan. 28;48(s1). doi: 10.4081/gimle.757Link provided by the sponsor.
- Santero S, Viroli G, Sofroniou A, Madini N, et al. Effectiveness and cost-effectiveness of dietary protocols for malnourished older adults: a systematic review. PROSPERO 2024Link provided by the sponsor.
- Santero S, Blagojevic B, Merzah M, Celada-Guerrero J, et al. Effect of fasting on muscle mass preservation in aging adults and older adults with or without a physical activity intervention: a scoping review. https://doi.org/10.17605/OSF.IO/3Y247Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hellas Cena, Prof principal investigator
Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy; Istituti Clinici Scientifici Maugeri IRCCS, Unit of Clinical Nutrition, Pavia, Italy
Flavia Magri, Prof principal investigator
Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy; Unit of Endocrinology and Metabolism, Laboratory for Endocrine Disruptors, Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy
Antonio Di Sabatino, Prof principal investigator
Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy; First Department of Internal Medicine, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Sarcopenia, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malnutrition in free-living and hospitalized older adults (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05860556, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.