Efficacy of Oral Nutritional Supplement in Community-Dwelling Adults Following Acute Care

Starting soon · Not applicable

Conditions studied: Low Muscle Strength, Malnutrition

In brief

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.

Key facts

Study ID

NCT07753239

Run by

Abbott Nutrition

People needed

304

Starts

2026-10-01

Expected to finish

2028-01-01

Last updated by the study team

2026-08-07

Who can join

Age: 55 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Community ambulant.
• No other chronic disease.
• Able to communicate and follow instructions.
• Able to consume food and beverages orally.
• Willing to refrain from taking non-study oral nutritional supplements over the course of the study.
• Able and willing to follow study procedures.

You may not qualify if…

• 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.
• With severe or unstable congestive heart failure.
• With chronic kidney disease stage 2 or higher, end-stage organ failure, or other pre-terminal condition.
• Has an active malignancy within the past five years or currently receiving treatment for malignancy.
• Has a severe or unstable musculoskeletal or neuromuscular disorder.
• Unable to perform a valid handgrip strength assessment.
• Any condition that makes the participant unsuitable for the study.
• Currently enrolled in another clinical study.
• Has an eating disorder, alcoholism or substance abuse.
• Has dementia, delirium, or a significant neurological or psychiatric disorder.
• Known allergy or intolerance to any ingredients of the study product.
• Continuous use of ONS for 14 days prior to the baseline visit.
• Has used herbal products, dietary supplements, or medications in the past 30 days that could affect body weight, appetite, or body composition.
• Presence of clinically significant ascites, pleural effusion, edema, or dehydration.

Where it is running

• King Chulalongkorn Memorial Hospital — Bangkok, Thailand
• Phramongkutklao Hospital — Bangkok, Thailand
• Siriraj Hospital — Bangkok, Thailand
• Vajira Hospital — Bangkok, Thailand
• Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand
• Songklanagarind Hospital — Hat Yai, Thailand
• Naresuan University Hospital — Phitsanulok, Thailand

Full record on ClinicalTrials.gov

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