Low Muscle StrengthNCT07753239
Efficacy of Oral Nutritional Supplement in Community-Dwelling Adults Following Acute Care
A study testing ONS in people with Low Muscle Strength and Malnutrition, run by Abbott Nutrition at 7 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 99 years
- Conditions the study is for
- Low Muscle Strength, Malnutrition
- What is being tested?
- ONS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 7 sitesThailand
- Study dates
- Oct 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Thailand7 sites
King Chulalongkorn Memorial Hospital
Bangkok
Phramongkutklao Hospital
Bangkok
Siriraj Hospital
Bangkok
Vajira Hospital
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Songklanagarind Hospital
Hat Yai
Naresuan University Hospital
Phitsanulok
About this study
Official 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
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
- Being tested
- ONS, Standard of Care (SOC)
- Keywords
- Oral nutritional supplement, Malnutrition, Nutritional risk, Low muscle strength, Handgrip strength, Post-discharge, Older adults, Body weight, Physical function, Sarcopenia
- Medical subject headings
- Malnutrition, Body Weight, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSDietary supplement
230 mL per serving, twice daily
Standard of Care (SOC)Other
Dietary counseling and physical activity advice
| Study group | Role | What they receive |
|---|---|---|
| Feeding: Intervention | Experimental | Not described Receives: Dietary Supplement: ONS; Other: Standard of Care (SOC) |
| Feeding: None | Other | Not described Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured in kg
Measured: Day 0 to Day 180
Secondary outcomes (13)
Change in body weight
Measured in kg
Measured: Study Day 30, Study Day 90 and Study Day 180
Body mass index (BMI)
Calculated as Weight (kg)/Height (m)2
Measured: Study Day 30, Study Day 90 and Study Day 180
Calf circumference
Measured in cm
Measured: Study Day 30, Study Day 90 and Study Day 180
Mid-upper arm circumference (MUAC)
Measured in cm
Measured: Study Day 30, Study Day 90 and Study Day 180
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.
Measured: Study Day 30, Study Day 90 and Study Day 180
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:
- Score of < 3 = Low risk
- Score of ≥ 3 = At nutritional risk
Measured: Study Day 30, Study Day 90 and Study Day 180
Handgrip strength
Maximum handgrip strength assessed using the Jamar dynamometer.
Measured: Study Day 30, Study Day 90 and Study Day 180
Short Physical Performance Battery (SPPB) total score
Short Physical Performance Battery total score ranges from 0 to 12; higher scores indicate better physical performance.
Measured: Study Day 30, Study Day 90 and Study Day 180
Short Physical Performance Battery (SPPB) component scores
Balance, 4-meter gait speed, and chair stand component scores; higher scores indicate better performance.
Measured: Study Day 30, Study Day 90 and Study Day 180
4-meter gait speed
4-meter gait speed, measured in meters per second.
Measured: Study Day 30, Study Day 90 and Study Day 180
Chair stand time
Chair stand time, measured in seconds.
Measured: Study Day 30, Study Day 90 and Study Day 180
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.
Measured: Study Day 30, Study Day 90 and Study Day 180
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).
Measured: Study Day 30, Study Day 90 and Study Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, controlled, open-label, parallel-design study.
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mandy Yen Ling Ow, Ph.D., Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753239
- Sponsor's protocol ID
- BL95
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07753239
- Acronym / sponsor ID
- BL95
- Conditions
- Low Muscle Strength, Malnutrition
- Keywords
- Oral nutritional supplement, Malnutrition, Nutritional risk, Low muscle strength, Handgrip strength, Post-discharge, Older adults, Body weight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, controlled, open-label, parallel-design study.
| Arm | Type | Receives |
|---|---|---|
| Feeding: Intervention | Experimental | Dietary Supplement: ONS, Other: Standard of Care (SOC) |
| Feeding: None | Other | Other: Standard of Care (SOC) |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONS230 mL per serving, twice daily | Dietary supplement | Feeding: Intervention |
| Standard of Care (SOC)Dietary counseling and physical activity advice | Other | Feeding: Intervention, Feeding: None |
Primary outcome
Change in body weight
Time frame: Day 0 to Day 180
Measured in kg
13 secondary outcomes
Change in body weight
Time frame: Study Day 30, Study Day 90 and Study Day 180
Body mass index (BMI)
Time frame: Study Day 30, Study Day 90 and Study Day 180
Calf circumference
Time frame: Study Day 30, Study Day 90 and Study Day 180
Mid-upper arm circumference (MUAC)
Time frame: Study Day 30, Study Day 90 and Study Day 180
Body composition
Time frame: Study Day 30, Study Day 90 and Study Day 180
Nutrition Risk
Time frame: Study Day 30, Study Day 90 and Study Day 180
Handgrip strength
Time frame: Study Day 30, Study Day 90 and Study Day 180
Short Physical Performance Battery (SPPB) total score
Time frame: Study Day 30, Study Day 90 and Study Day 180
Short Physical Performance Battery (SPPB) component scores
Time frame: Study Day 30, Study Day 90 and Study Day 180
4-meter gait speed
Time frame: Study Day 30, Study Day 90 and Study Day 180
Chair stand time
Time frame: Study Day 30, Study Day 90 and Study Day 180
Energy, macronutrient and micronutrient intakes
Time frame: Study Day 30, Study Day 90 and Study Day 180
Energy, macronutrient and micronutrient adequacy
Time frame: Study Day 30, Study Day 90 and Study Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mandy Yen Ling Ow, Ph.D. study chair
Abbott Nutrition
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS in people with Low Muscle Strength and Malnutrition, run by Abbott Nutrition at 7 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Qi Mak (+65 6801 6272, meiqi.mak@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Day 0 to Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.