Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sustainable Eating Pattern to Limit Malnutrition in Older Adults

Conditions
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Malnutrition, Sarcopenia

Intervention / Treatment
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* Other: Nutrition intervention (dietary protocol)
* Other: Hospital standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial with two parallel arms. The intervention group will receive a nutritional protocol and the control group will receive the standard of care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention<br>Nutritional intervention consist in a macro- and micronutrients balanced nutritional protocol with a focus on sustainability and personalized according to the individual malnutrition severity. In particular, an adequate coverage of energy, protein and water requirements will be guaranteed according to Italian reference values (LARN) and European (ESPEN) guidelines. In light of the scientific literature and the principal issues founding in malnourished older people, the proposed nutritional protocol will provide an adequate and sustainable consumption of animal and vegetable proteins and an appropriate water intake. The nutritional intervention will be carried out by a qualified staff. | Other: Nutrition intervention (dietary protocol)<br>* 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.<br>|
| Other: Control<br>The control group receive the standard of care provided for malnutrition treatment by hospitals | Other: Hospital standard of care<br>* The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nutritional status pre- and post- intervention between experimental and control group measuring weight | Weight gain= + 2kg | 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 | 24 months (baseline, 3 months, 6 months and 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 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) | 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) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase | Creatin Kinase (UI/L) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood prealbumin | prealbumin (g/mL) | 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) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for glycemia. | glycemia (mg/dl) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood insulin | Insulin (µU/mL) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood homocysteine | Homocysteine (µmol/L) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood vitamine D | vitamine D (ng/ml) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood vitamine B12 | vitamine 12 (pg/ml) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood vitamine B9 | vitamine 9 (ng/mL) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood sodium (Na) | Na (mmol/L) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood potassium (K) | K (mEq/l) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg) | Mg (mEq/l) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca) | Ca (mg/dL) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood iron (Fe) | Fe (μg) | 24 months (baseline and 6 months) | 
| Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn) | Zn (mmol/l) | 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. | 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 | 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 | 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 | 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 | 24 months (baseline, 6 months and 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition intervention, older adults, malnutrition, sustainability, 24-h recall, sarcopenia, nutritional protocol