CClinicalTrials.gg
Sign In
Not yet recruitingNCT07753239Updated Aug 7, 2026

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

An interventional study of ONS and Standard of Care (SOC) in Low Muscle Strength and Malnutrition, sponsored by Abbott Nutrition. Not yet recruiting at 7 sites in Thailand. Open to participants aged 55 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
55 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
55 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
304 participants (estimated)

Study arms

  • Experimental
    Feeding: Intervention

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

  • Other
    Feeding: None

    Other: Standard of Care (SOC)

Interventions

  • Dietary supplementONS

    230 mL per serving, twice daily

  • OtherStandard of Care (SOC)

    Dietary counseling and physical activity advice

05

What researchers measure

Primary outcomes

  1. Change in body weight

    Measured in kg

    Time frame: Day 0 to Day 180

Secondary outcomes

  1. Change in body weight

    Measured in kg

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

  2. Body mass index (BMI)

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

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

  3. Calf circumference

    Measured in cm

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

  4. Mid-upper arm circumference (MUAC)

    Measured in cm

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

  5. Body composition

    Body composition variables assessed by bioelectrical impedance analysis (BIA), including appendicular skeletal muscle mass, lean mass, fat-free mass, fat mass, and derived indices.

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

  6. Nutrition Risk

    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: 1. Score of \< 3 = Low risk 2. Score of ≥ 3 = At nutritional risk

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

  7. Handgrip strength

    Maximum handgrip strength assessed using the Jamar dynamometer.

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

  8. Short Physical Performance Battery (SPPB) total score

    Short Physical Performance Battery total score ranges from 0 to 12; higher scores indicate better physical performance.

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

  9. Short Physical Performance Battery (SPPB) component scores

    Balance, 4-meter gait speed, and chair stand component scores; higher scores indicate better performance.

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

  10. 4-meter gait speed

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

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

  11. Chair stand time

    Chair stand time, measured in seconds.

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

  12. Energy, macronutrient and micronutrient intakes

    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.

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

  13. Energy, macronutrient and micronutrient adequacy

    Nutrient adequacy will be determined by comparing nutrient intakes (outcome No. 10) against sex- and age- specific local recommended nutrient intakes (RNI).

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

06

Study locations

7 sites
  • 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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07753239
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 7, 2026

Study contacts

Mei Qi Mak
Contact
meiqi.mak@abbott.com
+65 6801 6272
Mandy Yen Ling Ow, Ph.D.
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Malnutrition→

Other studies from this sponsor

Abbott Nutrition

Start the discussion