Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

Sarcopenia Clinical Trial

— SENIOR  

Official title:

Sustainable Eating Pattern to Limit Malnutrition in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05853874
• Other study ID #: 22042023
• Secondary ID: CUP: F13C2200121
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2026

Study information

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

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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Intervention

Other:
• Nutrition intervention (dietary protocol)
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.
• Hospital standard of care
The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals

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	Change in nutritional status pre- and post- intervention between experimental and control group measuring weight	Weight gain= + 2kg	24 months (baseline, 3 months, 6 months and 12 months)
Primary	Change in nutritional status pre- and post- intervention between experimental and control group measuring strength	Increase in strength = + 1 kg	24 months (baseline, 3 months, 6 months and 12 months)
Secondary	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).	24 months (baseline and 6 months)
Secondary	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)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)	C reactive Protein (CRP) (mg/dl)	24 months (baseline and 6 months)
Secondary	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)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase	Creatin Kinase (UI/L)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood prealbumin	prealbumin (g/mL)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood cytokine	interleukin-1ß, interleukin-6, interleukin-10, tumor necrosis factor-a, transforming tumor factor-ß (pg/ml)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for glycemia.	glycemia (mg/dl)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood insulin	Insulin (µU/mL)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood homocysteine	Homocysteine (µmol/L)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood vitamine D	vitamine D (ng/ml)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood vitamine B12	vitamine 12 (pg/ml)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood vitamine B9	vitamine 9 (ng/mL)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)	Na (mmol/L)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood potassium (K)	K (mEq/l)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)	Mg (mEq/l)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)	Ca (mg/dL)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)	Fe (µg)	24 months (baseline and 6 months)
Secondary	Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)	Zn (mmol/l)	24 months (baseline and 6 months)
Secondary	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.	24 months (baseline, 6 months and 12 months)
Secondary	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	24 months (baseline, 6 months and 12 months)
Secondary	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	24 months (baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months)
Secondary	Changes pre- and post- intervention between experimental and control groups of fat free mass	Improvement of the phase angle (?) measured by bioimpedance analysis	24 months (baseline, 6 months and 12 months)
Secondary	Changes pre- and post- intervention between experimental and control groups in locomotion test	Velocity walking increase measured with gait speed test	24 months (baseline, 6 months and 12 months)