Malnutrition, Sarcopenia
Conditions
Keywords
GLIM, older adults, prevalence, hospital, nutrition, risk factor, malnutrition, sarcopenia, sustainability
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 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.
Interventions
None listed
Sponsors
University of Pavia
Fondazione IRCCS Policlinico San Matteo di Pavia
Fondazione IRCCS San Gerardo dei Tintori
Fondazione Salvatore Maugeri
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
65 Years to 120 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of malnutrition in free-living and hospitalized older adults | Day 1 | Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of sarcopenia in free-living and hospitalized older adults | Day 1 | Sarcopenia diagnosis (EWGSOP2) |
| Level of physical activity in free-living and hospitalized older adults | Day 1 | 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 |
| Activities of daily living | Day 1 | 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. |
| Level of adherence to Mediterranean diet in free-living and hospitalized older adults | Day 1 | Medi-Lite adherence score questionnaire. Total score ranges between 0-18. A high score represents a higher adherence to Mediterranean diet |
| Level of adherence to Mind Diet in free-living and hospitalized older adults | Day 1 | Mind diet score. Total score ranges from 0 to 15. A higher score indicate a higher adherence to Mind Diet |
| Sleep quality in free-living and hospitalized older adults | Day 1 | pittsburgh sleep quality index. Total score ranges between 0-21. A higher score represents higher sleep difficulties |
| Level of quality of life in free-living and hospitalized older adults | Day 1 | Short-Form Health Survey 12. Total score ranges between 0-100. A higher score represents a better quality of life |
| Level of intrinsic capacity in free-living and hospitalized older adults | Day 1 | 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 |
| Level of depression in free-living and hospitalized older adults | Day 1 | Geriatric Depression Scale. Total score ranges between 0-15. A higher score represents higher depression status |
| Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults | Day 1 | 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)) |
| Socio-demographic characteristic in free-living and hospitalized older adults | Day 1 | 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) |
| Vitamin D deficiency in free-living and hospitalized older adults | Day 1 | Evaluation Vitamin D dEficieNCy Questionnaire (EVIDENCe-Q). Total range from 0 (better status) to 36 (worsen status). |
| Body Mass Index (BMI) in free-living and hospitalized older adults | Day 1 | 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) |
| Height derived by knee height in free-living and hospitalized older adults | Day 1 | Height derived by knee height (cm) through validated equation. |
| Referred height in free-living and hospitalized older adults | Day 1 | Referred height (cm) with a structured question |
| Waist circumference in free-living and hospitalized older adults | Day 1 | Waist circumference (cm) through an anelastic tape. |
| Mid-arm circumference in free-living and hospitalized older adults | Day 1 | Mid-arm circumference (cm) through an anelastic tape. |
| Calf circumference in free-living and hospitalized older adults | Day 1 | Calf circumference (cm) through an anelastic tape. |
| Mid-thigh circumference in free-living and hospitalized older adults | Day 1 | Mid-thigh circumference (cm) measured with an anelastic tape |
| Fat-Free Mass (FFM) in free-living and hospitalized older adults | Day 1 | Fat-Free Mass (FFM, KG) measured by Bioelectrical Impedance Analysis (BIA) |
| Fat Mass (FM) in free-living and hospitalized older adults | Day 1 | Fat Mass (FM, kg) measured by Bioelectrical Impedance Analysis (BIA) |
| Body Water in free-living and hospitalized older adults | Day 1 | Total Body Water (TBW, l), Extracellular Water (ECW, l) and Intracellular Water (ICW, l) measured by Bioelectrical Impedance Analysis (BIA) |
| Phase angle in free-living and hospitalized older adults | Day 1 | Phase angle (θ) measured by Bioelectrical Impedance Analysis (BIA) |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORHellas Cena, Prof
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
PRINCIPAL_INVESTIGATORFlavia Magri, Prof
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
PRINCIPAL_INVESTIGATORAntonio Di Sabatino, Prof
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
PRINCIPAL_INVESTIGATORMaria Emilia Paladino, Dr
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
Outcome results
None listed