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

University of Pavia

Status: Not yet enrolling

Conditions: Malnutrition; Sarcopenia

Treatments: Other: Hospital standard of care; Other: Nutrition intervention (dietary protocol)

Study type: Interventional

Funder types: Other

Identifiers

NCT05853874

CUP: F13C22001210007 (Other Grant/Funding Number)

22042023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Nutritional intervention

Experimental group

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.

Treatment:

Other: Nutrition intervention (dietary protocol)

Control

Other group

Description:

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

Treatment:

Other: Hospital standard of care