Sustainable Eating Pattern to Limit Malnutrition in Older Adults

Sarcopenia Clinical Trial

— SENIOR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860556
• Other study ID #: 21042023
• Secondary ID: CUP: F13C2200121
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2026

Study information

• Verified date: May 2023
• Source: University of Pavia
• Contact: Ilaria Di Napoli, Dr
• Phone: 3289440188
• Email: ilariadinapoli[@]unipv.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pavia	Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione Salvatore Maugeri

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of malnutrition in free-living and hospitalized older adults	Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool	Day 1
Secondary	Prevalence of sarcopenia in free-living and hospitalized older adults	Sarcopenia diagnosis (EWGSOP2)	Day 1
Secondary	Level of physical activity in free-living and hospitalized older adults	Physical Activity Scale for the Elderly questionnaire. Total score ranges from 0 to 450 and an higher score represents a higher level of physical activity.; OR Barthel Index. The total score ranges from 0 to 100. The lower score indicates a totally dependent and a higher score indicates a higher independence in daily activities	Day 1
Secondary	Level of adherence to Mediterranean diet in free-living and hospitalized older adults	Medi-Lite adherence score questionnaire. Total score ranges between 0-18. A high score represents a higher adherence to Mediterranean diet	Day 1
Secondary	Level of adherence to Mind Diet in free-living and hospitalized older adults	Mind diet score. Total score ranges from 0 to 15. A higher score indicate a higher adherence to Mind Diet	Day 1
Secondary	Sleep quality in free-living and hospitalized older adults	pittsburgh sleep quality index. Total score ranges between 0-21. A higher score represents higher sleep difficulties	Day 1
Secondary	Level of quality of life in free-living and hospitalized older adults	Short-Form Health Survey 12. Total score ranges between 0-100. A higher score represents a better quality of life	Day 1
Secondary	Level of depression in free-living and hospitalized older adults	Geriatric Depression Scale. Total score ranges between 0-15. A higher score represents higher depression status	Day 1
Secondary	Level of intrinsic capacity in free-living and hospitalized older adults	Locomotion (4 m gait speed) (m/s); score ranges between 0-2; Vitality (malnutrition according to GLIM criteria); score ranges between 0-2; Cognition (Mini Mental State Examination); score ranges between 0-2; Psychological state (geriatric depression scale); score ranges between 0-2 The scores of the precedent domains will be summarized to calculate the intrinsic capacity total score, which ranges from 0 to 8. A higher score represents a higher intrinsic capacity	Day 1
Secondary	Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults	Biomarkers blood measured from fasting blood samples are: Complete blood count with leukocyte count Lipid profile (Low density lipoprotein, high density lipoprotein, total cholesterol, triglycerides) (mg/dl) C reactive Protein (CRP) (mg/dl) Plasmatic creatinine (mg/dl) Transaminases (glutamic oxaloacetic transaminase, Glutamic-Pyruvic Transaminase, gamma-glutamyl transferase) (U/I) Alkaline phosphatase (U/L) Creatin Kinase (UI/L) Prealbumin (g/mL) Cytokine (interleukin-1ß, interleukin-6, interleukin-10, tumor necrosis factor-a, transforming tumor factor-ß) Glycemia (mg/dl) Insulin (µU/mL) Homocysteine (µmol/L) Vitamines (D, B12, B9) Minerals (Na, K, Mg, Ca, Fe, Zn)	Day 1
Secondary	Socio-demographic characteristic in free-living and hospitalized older adults	Structured interview (sex, age, ethnicity, level of education, socioeconomic status, number of people in the house, type of job)	Day 1