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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
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.
The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals
Change in nutritional status pre- and post- intervention between experimental and control group measuring weight
Weight gain= + 2kg
Time frame: 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
Time frame: 24 months (baseline, 3 months, 6 months and 12 months)
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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase
Creatin Kinase (UI/L)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood prealbumin
prealbumin (g/mL)
Time frame: 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)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for glycemia.
glycemia (mg/dl)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood insulin
Insulin (µU/mL)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood homocysteine
Homocysteine (µmol/L)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood vitamine D
vitamine D (ng/ml)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood vitamine B12
vitamine 12 (pg/ml)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood vitamine B9
vitamine 9 (ng/mL)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)
Na (mmol/L)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood potassium (K)
K (mEq/l)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)
Mg (mEq/l)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)
Ca (mg/dL)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)
Fe (μg)
Time frame: 24 months (baseline and 6 months)
Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)
Zn (mmol/l)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 months (baseline, 6 months and 12 months)
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