Clinical trial NCT05853874: Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Official title: Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition
Sarcopenia
Keywords: Nutrition intervention
older adults
malnutrition
sustainability
24-h recall
sarcopenia
nutritional protocol
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione Salvatore Maugeri
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2023-05-11
Enrollment: 128
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in nutritional status pre- and post- intervention between experimental and control group measuring weight
timeFrame: 24 months (baseline, 3 months, 6 months and 12 months)
measure: Change in nutritional status pre- and post- intervention between experimental and control group measuring strength
timeFrame: 24 months (baseline, 3 months, 6 months and 12 months)
Secondary outcomes:
measure: Changes pre- and post- intervention between experimental and control groups for complete blood count
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood lipid profile
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood transaminases
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood prealbumin
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood cytokine
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for glycemia.
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood insulin
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood homocysteine
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood vitamine D
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood vitamine B12
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood vitamine B9
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood potassium (K)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)
timeFrame: 24 months (baseline and 6 months)
measure: Changes pre- and post- intervention between experimental and control groups for adherence to Mediterranean Diet
timeFrame: 24 months (baseline, 6 months and 12 months)
measure: Changes pre- and post- intervention between experimental and control groups for the quality of life
timeFrame: 24 months (baseline, 6 months and 12 months)
measure: Changes pre- and post- intervention between experimental and control groups for the dietary nutritional composition
timeFrame: 24 months (baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months)
measure: Changes pre- and post- intervention between experimental and control groups of fat free mass
timeFrame: 24 months (baseline, 6 months and 12 months)
measure: Changes pre- and post- intervention between experimental and control groups in locomotion test
timeFrame: 24 months (baseline, 6 months and 12 months)
Other outcomes:
Locations:
Study officials:
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
name: Hellas Cena, Prof
role: PRINCIPAL_INVESTIGATOR
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
name: Flavia Magri, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine and Therapeutics, University of Pavia; Fondazione IRCCS Policlinico San Matteo, Internal Medicine Unit, Pavia
name: Antonio Di Sabatino, Prof
role: PRINCIPAL_INVESTIGATOR
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