Efficacy of Oral Nutritional Supplement in Community-Dwelling Adults Following Acute Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-99
SponsorAbbott Nutrition
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At risk of malnutrition.
At the point of hospital discharge, the admission was for an acute medical illness.
Has low maximum handgrip strength.
Estimated life expectancy of more than 12 months.
Disqualifiers
Index hospitalization admission was for a surgical procedure or a stroke/myocardial infarction.
Diagnosed with type 1 or type 2 diabetes.
Has an active infectious disease.
Diagnosed with severe gastrointestinal disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
ONS
Dietary supplement230 mL per serving, twice daily
Standard of Care (SOC)
Other interventionDietary counseling and physical activity advice
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: Feeding: InterventionExperimental treatment 2 interventions
Group B: Feeding: NoneOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in body weight
Measured in kg
Time frame
Day 0 to Day 180Secondary outcomes
1
Change in body weight
Measured in kg
Time frame
Study Day 30, Study Day 90 and Study Day 1802
Body mass index (BMI)
Calculated as Weight (kg)/Height (m)2
Time frame
Study Day 30, Study Day 90 and Study Day 1803
Calf circumference
Measured in cm
Time frame
Study Day 30, Study Day 90 and Study Day 1804
Mid-upper arm circumference (MUAC)
Measured in cm
Time frame
Study Day 30, Study Day 90 and Study Day 180Sponsors and contacts
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Source ClinicalTrials.gov
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