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Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults (SENIOR)

Primary Purpose

Malnutrition, Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition intervention (dietary protocol)
Hospital standard of care
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Nutrition intervention, older adults, malnutrition, sustainability, 24-h recall, sarcopenia, nutritional protocol

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Nutritional intervention

    Control

    Arm Description

    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.

    The control group receive the standard of care provided for malnutrition treatment by hospitals

    Outcomes

    Primary Outcome Measures

    Change in nutritional status pre- and post- intervention between experimental and control group measuring weight
    Weight gain= + 2kg
    Change in nutritional status pre- and post- intervention between experimental and control group measuring strength
    Increase in strength = + 1 kg

    Secondary Outcome Measures

    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).
    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)
    Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)
    C reactive Protein (CRP) (mg/dl)
    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)
    Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase
    Creatin Kinase (UI/L)
    Changes pre- and post- intervention between experimental and control groups for blood prealbumin
    prealbumin (g/mL)
    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)
    Changes pre- and post- intervention between experimental and control groups for glycemia.
    glycemia (mg/dl)
    Changes pre- and post- intervention between experimental and control groups for blood insulin
    Insulin (µU/mL)
    Changes pre- and post- intervention between experimental and control groups for blood homocysteine
    Homocysteine (µmol/L)
    Changes pre- and post- intervention between experimental and control groups for blood vitamine D
    vitamine D (ng/ml)
    Changes pre- and post- intervention between experimental and control groups for blood vitamine B12
    vitamine 12 (pg/ml)
    Changes pre- and post- intervention between experimental and control groups for blood vitamine B9
    vitamine 9 (ng/mL)
    Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)
    Na (mmol/L)
    Changes pre- and post- intervention between experimental and control groups for blood potassium (K)
    K (mEq/l)
    Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)
    Mg (mEq/l)
    Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)
    Ca (mg/dL)
    Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)
    Fe (μg)
    Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)
    Zn (mmol/l)
    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.
    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
    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
    Changes pre- and post- intervention between experimental and control groups of fat free mass
    Improvement of the phase angle (θ) measured by bioimpedance analysis
    Changes pre- and post- intervention between experimental and control groups in locomotion test
    Velocity walking increase measured with gait speed test

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    May 8, 2023
    Sponsor
    University of Pavia
    Collaborators
    Fondazione Salvatore Maugeri, Fondazione IRCCS Policlinico San Matteo di Pavia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05853874
    Brief Title
    Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults
    Acronym
    SENIOR
    Official Title
    Sustainable Eating Pattern to Limit Malnutrition in Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2026 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pavia
    Collaborators
    Fondazione Salvatore Maugeri, Fondazione IRCCS Policlinico San Matteo di Pavia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition, Sarcopenia
    Keywords
    Nutrition intervention, older adults, malnutrition, sustainability, 24-h recall, sarcopenia, nutritional protocol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutritional intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    The control group receive the standard of care provided for malnutrition treatment by hospitals
    Intervention Type
    Other
    Intervention Name(s)
    Nutrition intervention (dietary protocol)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Hospital standard of care
    Intervention Description
    The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals
    Primary Outcome Measure Information:
    Title
    Change in nutritional status pre- and post- intervention between experimental and control group measuring weight
    Description
    Weight gain= + 2kg
    Time Frame
    24 months (baseline, 3 months, 6 months and 12 months)
    Title
    Change in nutritional status pre- and post- intervention between experimental and control group measuring strength
    Description
    Increase in strength = + 1 kg
    Time Frame
    24 months (baseline, 3 months, 6 months and 12 months)
    Secondary Outcome Measure Information:
    Title
    Changes pre- and post- intervention between experimental and control groups for complete blood count
    Description
    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)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood lipid profile
    Description
    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)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)
    Description
    C reactive Protein (CRP) (mg/dl)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood transaminases
    Description
    (glutamic oxaloacetic transaminase, Glutamic-Pyruvic Transaminase, gamma-glutamyl transferase) (U/I) Alkaline phosphatase (U/L)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase
    Description
    Creatin Kinase (UI/L)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood prealbumin
    Description
    prealbumin (g/mL)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood cytokine
    Description
    interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α, transforming tumor factor-β (pg/ml)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for glycemia.
    Description
    glycemia (mg/dl)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood insulin
    Description
    Insulin (µU/mL)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood homocysteine
    Description
    Homocysteine (µmol/L)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood vitamine D
    Description
    vitamine D (ng/ml)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood vitamine B12
    Description
    vitamine 12 (pg/ml)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood vitamine B9
    Description
    vitamine 9 (ng/mL)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)
    Description
    Na (mmol/L)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood potassium (K)
    Description
    K (mEq/l)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)
    Description
    Mg (mEq/l)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)
    Description
    Ca (mg/dL)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)
    Description
    Fe (μg)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)
    Description
    Zn (mmol/l)
    Time Frame
    24 months (baseline and 6 months)
    Title
    Changes pre- and post- intervention between experimental and control groups for adherence to Mediterranean Diet
    Description
    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)
    Title
    Changes pre- and post- intervention between experimental and control groups for the quality of life
    Description
    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)
    Title
    Changes pre- and post- intervention between experimental and control groups for the dietary nutritional composition
    Description
    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)
    Title
    Changes pre- and post- intervention between experimental and control groups of fat free mass
    Description
    Improvement of the phase angle (θ) measured by bioimpedance analysis
    Time Frame
    24 months (baseline, 6 months and 12 months)
    Title
    Changes pre- and post- intervention between experimental and control groups in locomotion test
    Description
    Velocity walking increase measured with gait speed test
    Time Frame
    24 months (baseline, 6 months and 12 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ilaria Di Napoli, Dr
    Phone
    3289440188
    Email
    ilaria.dinapoli@unipv.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara Santero, Dr
    Phone
    3312747536
    Email
    sara.santero@unipv.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hellas Cena, Prof
    Organizational Affiliation
    Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia; Clinical Nutrition and Dietetics Service, Unit of Internal Medicine and Endocrinology, Pavia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Flavia Magri, Prof
    Organizational Affiliation
    Department of Internal Medicine and Therapeutics, University of Pavia and Istituti Clinici Scientifici Maugeri IRCCS, Unit of Internal Medicine and Endocrinology; Istituti Clinici Scientifici Maugeri IRCCS, Unit of Endocrinology and Metabolism, Pavia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Antonio Di Sabatino, Prof
    Organizational Affiliation
    Department of Internal Medicine and Therapeutics, University of Pavia; Fondazione IRCCS Policlinico San Matteo, Internal Medicine Unit, Pavia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

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