Low Muscle Strength, Malnutrition
Conditions
Keywords
Oral nutritional supplement, Malnutrition, Nutritional risk, Low muscle strength, Handgrip strength, Post-discharge, Older adults, Body weight, Physical function, Sarcopenia
Brief summary
The study aims to determine the effects of Oral Nutritional Supplement (ONS) added to usual care on body weight compared with usual care alone in community-dwelling adults aged 55 years and older who are at risk of malnutrition and have low muscle strength following acute care. Participants randomized to receive either ONS twice daily for 180 days plus usual care, or usual care alone. Usual care includes individualized dietary counseling and standardized physical activity advice provided. The study will assess body weight, nutritional status, muscle strength, physical function, dietary intake, and safety outcomes.
Interventions
DIETARY_SUPPLEMENTONS
230 mL per serving, twice daily
OTHERStandard of Care (SOC)
Dietary counseling and physical activity advice
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, multicenter, randomized, controlled, open-label, parallel-design study.
Eligibility
Sex/Gender
ALL
Age
55 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. At risk of malnutrition. 2. At the point of hospital discharge, the admission was for an acute medical illness. 3. Has low maximum handgrip strength. 4. Estimated life expectancy of more than 12 months. 5. Community ambulant. 6. No other chronic disease. 7. Able to communicate and follow instructions. 8. Able to consume food and beverages orally. 9. Willing to refrain from taking non-study oral nutritional supplements over the course of the study. 10. Able and willing to follow study procedures.
Exclusion criteria
1. Index hospitalization admission was for a surgical procedure or a stroke/myocardial infarction. 2. Diagnosed with type 1 or type 2 diabetes. 3. Has an active infectious disease. 4. Diagnosed with severe gastrointestinal disorders. 5. With severe or unstable congestive heart failure. 6. With chronic kidney disease stage 2 or higher, end-stage organ failure, or other pre-terminal condition. 7. Has an active malignancy within the past five years or currently receiving treatment for malignancy. 8. Has a severe or unstable musculoskeletal or neuromuscular disorder. 9. Unable to perform a valid handgrip strength assessment. 10. Any condition that makes the participant unsuitable for the study. 11. Currently enrolled in another clinical study. 12. Has an eating disorder, alcoholism or substance abuse. 13. Has dementia, delirium, or a significant neurological or psychiatric disorder. 14. Known allergy or intolerance to any ingredients of the study product. 15. Continuous use of ONS for 14 days prior to the baseline visit. 16. Has used herbal products, dietary supplements, or medications in the past 30 days that could affect body weight, appetite, or body composition. 17. Presence of clinically significant ascites, pleural effusion, edema, or dehydration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Day 0 to Day 180 | Measured in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Study Day 30, Study Day 90 and Study Day 180 | Measured in kg |
| Body mass index (BMI) | Study Day 30, Study Day 90 and Study Day 180 | Calculated as Weight (kg)/Height (m)2 |
| Calf circumference | Study Day 30, Study Day 90 and Study Day 180 | Measured in cm |
| Mid-upper arm circumference (MUAC) | Study Day 30, Study Day 90 and Study Day 180 | Measured in cm |
| Body composition | Study Day 30, Study Day 90 and Study Day 180 | Body composition variables assessed by bioelectrical impedance analysis (BIA), including appendicular skeletal muscle mass, lean mass, fat-free mass, fat mass, and derived indices. |
| Nutrition Risk | Study Day 30, Study Day 90 and Study Day 180 | Nutritional Risk Screening (NRS-2002) is a clinical tool used to identify persons at risk of malnutrition. It classifies participants into one of the 2 categories: 1. Score of \< 3 = Low risk 2. Score of ≥ 3 = At nutritional risk |
| Handgrip strength | Study Day 30, Study Day 90 and Study Day 180 | Maximum handgrip strength assessed using the Jamar dynamometer. |
| Short Physical Performance Battery (SPPB) total score | Study Day 30, Study Day 90 and Study Day 180 | Short Physical Performance Battery total score ranges from 0 to 12; higher scores indicate better physical performance. |
| Short Physical Performance Battery (SPPB) component scores | Study Day 30, Study Day 90 and Study Day 180 | Balance, 4-meter gait speed, and chair stand component scores; higher scores indicate better performance. |
| 4-meter gait speed | Study Day 30, Study Day 90 and Study Day 180 | 4-meter gait speed, measured in meters per second. |
| Chair stand time | Study Day 30, Study Day 90 and Study Day 180 | Chair stand time, measured in seconds. |
| Energy, macronutrient and micronutrient intakes | Study Day 30, Study Day 90 and Study Day 180 | 24-Hour Dietary Recall: Researcher-led interview on food and drink intake the previous day. Nutrient analysis will be performed using a dietary analysis program. |
| Energy, macronutrient and micronutrient adequacy | Study Day 30, Study Day 90 and Study Day 180 | Nutrient adequacy will be determined by comparing nutrient intakes (outcome No. 10) against sex- and age- specific local recommended nutrient intakes (RNI). |
Countries
Thailand
Contacts
CONTACTMei Qi Mak
STUDY_CHAIRMandy Yen Ling Ow, Ph.D.
Abbott Nutrition
Outcome results
None listed