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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 (part of Abbott) · 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

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 304 is above the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.

Browse Abbott Nutrition studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 ascites, pleural effusion, edema, or dehydration.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

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

06

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

07

Study locations

7 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.

Of 418 interventional studies with no phase under Malnutrition, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2026
First posted
Aug 7, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

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