ONS
Dietary Supplement230 mL per serving, twice daily
NCT Number: NCT07753239
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.
Trial opening soon.
Get Notified55 year–99 year
All sexes
Interventional
Not applicable
King Chulalongkorn Memorial Hospital, Bangkok, Thailand
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
230 mL per serving, twice daily
Dietary counseling and physical activity advice
Time frame: Day 0 to Day 180
Measured in kg
Time frame: Study Day 30, Study Day 90 and Study Day 180
Measured in kg
Time frame: Study Day 30, Study Day 90 and Study Day 180
Calculated as Weight (kg)/Height (m)2
Time frame: Study Day 30, Study Day 90 and Study Day 180
Measured in cm
Time frame: Study Day 30, Study Day 90 and Study Day 180
Measured in cm
Time frame: 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.
Time frame: 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:
Time frame: Study Day 30, Study Day 90 and Study Day 180
Maximum handgrip strength assessed using the Jamar dynamometer.
Time frame: 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.
Time frame: 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.
Time frame: Study Day 30, Study Day 90 and Study Day 180
4-meter gait speed, measured in meters per second.
Time frame: Study Day 30, Study Day 90 and Study Day 180
Chair stand time, measured in seconds.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Abbott Nutrition
Industry
Efficacy of Oral Nutritional Supplementation Added to Usual Care in Community-dwelling Adults at Risk of Malnutrition and With Low Muscle Strength Following Acute Care
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