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

NCT07753239 | Not Yet Recruiting

• 1 other identifier: BL95
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 7

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.

Conditions

Low Muscle Strength; Malnutrition

Keywords

Oral nutritional supplement; Malnutrition; Nutritional risk; Low muscle strength; Handgrip strength; Post-discharge; Older adults; Body weight; Physical function; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Measured in kg

  Day 0 to Day 180

Secondary Outcomes (13)

• Change in body weight

  Study Day 30, Study Day 90 and Study Day 180

• Body mass index (BMI)

  Study Day 30, Study Day 90 and Study Day 180

• Calf circumference

  Study Day 30, Study Day 90 and Study Day 180

• Mid-upper arm circumference (MUAC)

  Study Day 30, Study Day 90 and Study Day 180

• Body composition

  Study Day 30, Study Day 90 and Study Day 180

Study Arms (2)

Feeding: Intervention

EXPERIMENTAL

Dietary Supplement: ONS; Other: Standard of Care (SOC)

Feeding: None

OTHER

Other: Standard of Care (SOC)

Interventions

ONS DIETARY_SUPPLEMENT

230 mL per serving, twice daily

Feeding: Intervention

Standard of Care (SOC) OTHER

Dietary counseling and physical activity advice

Feeding: Intervention; Feeding: None

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (7)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Vajira Hospital

Bangkok, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

Songklanagarind Hospital

Hat Yai, Thailand

Location

Naresuan University Hospital

Phitsanulok, Thailand

Location

MeSH Terms

Conditions

Malnutrition; Body Weight; Sarcopenia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mandy Yen Ling Ow, Ph.D.

  Abbott Nutrition

  STUDY CHAIR

Central Study Contacts

Mei Qi Mak

CONTACT

+65 6801 6272; meiqi.mak@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized, controlled, open-label, parallel-design study.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (7)