Clinical trial NCT05860556: Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Official title: Sustainable Eating Pattern to Limit Malnutrition in Older Adults (SENIOR)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malnutrition
Sarcopenia
Keywords: GLIM
older adults
prevalence
hospital
nutrition
risk factor
malnutrition
sarcopenia
sustainability
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione Salvatore Maugeri
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2023-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults (over 65 years old), free-living or hospitalized, admitted at the hospitals

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 two North Italian Scientific Hospitalization and Treatment Institution in Pavia on older adults (≥ 65 years old). The estimated duration is 36 months with an preferred starting date on September 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, 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 two 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, if the subject has physical limitation, with the 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.

Anthropometric variables include weight, height (knee height and demi-span), waist circumference, and body composition (bioimpedance analysis, 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. Intrinsic capacity is a score developed by the World Health Organisation (WHO) which capture the psychological and physical condition of the older adults. In this study four out of five dimensions of the intrinsic capacity will be evaluated: locomotion, vitality, cognition and psychological.

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 U.O. of General Medicine and to U.O.S.D. of Endocrinology and Metabolic diseases of two Scientific Hospitalization and Treatment Institutions of Pavia, Italy
* Informed consent written and signed

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

Primary outcomes:
measure: Prevalence of malnutrition in free-living and hospitalized older adults
timeFrame: Day 1
Secondary outcomes:
measure: Prevalence of sarcopenia in free-living and hospitalized older adults
timeFrame: Day 1
measure: Level of physical activity in free-living and hospitalized older adults
timeFrame: Day 1
measure: Level of adherence to Mediterranean diet in free-living and hospitalized older adults
timeFrame: Day 1
measure: Level of adherence to Mind Diet in free-living and hospitalized older adults
timeFrame: Day 1
measure: Sleep quality in free-living and hospitalized older adults
timeFrame: Day 1
measure: Level of quality of life in free-living and hospitalized older adults
timeFrame: Day 1
measure: Level of depression in free-living and hospitalized older adults
timeFrame: Day 1
measure: Level of intrinsic capacity in free-living and hospitalized older adults
timeFrame: Day 1
measure: Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults
timeFrame: Day 1
measure: Socio-demographic characteristic in free-living and hospitalized older adults
timeFrame: Day 1
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
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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