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

N/ANot Yet RecruitingNCT07753239

Abbott Nutrition304 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

304

Conditions

Low Muscle Strength Malnutrition

Interventions

Eligibility

Sex: ALLMin age: 55 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

Change in body weight

Measured in kg

Time frame: Day 0 to Day 180