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NCT Number: NCT07753239

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

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.

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Key information

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ONS

Dietary Supplement

230 mL per serving, twice daily

Standard of Care (SOC)

Other

Dietary counseling and physical activity advice

Primary outcomes

  1. Change in body weight

    Time frame: Day 0 to Day 180

    Measured in kg

Secondary outcomes

  1. Change in body weight

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    Measured in kg

  2. Body mass index (BMI)

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    Calculated as Weight (kg)/Height (m)2

  3. Calf circumference

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    Measured in cm

  4. Mid-upper arm circumference (MUAC)

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    Measured in cm

  5. Body composition

    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.

  6. Nutrition Risk

    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:

    • Score of < 3 = Low risk
    • Score of ≥ 3 = At nutritional risk
  7. Handgrip strength

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    Maximum handgrip strength assessed using the Jamar dynamometer.

  8. Short Physical Performance Battery (SPPB) total score

    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.

  9. Short Physical Performance Battery (SPPB) component scores

    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.

  10. 4-meter gait speed

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    4-meter gait speed, measured in meters per second.

  11. Chair stand time

    Time frame: Study Day 30, Study Day 90 and Study Day 180

    Chair stand time, measured in seconds.

  12. Energy, macronutrient and micronutrient intakes

    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.

  13. Energy, macronutrient and micronutrient adequacy

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Qi Mak

CONTACT

[email protected]

+65 6801 6272

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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