Menu
Not yet recruiting NCT07753239

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

No phase Interventional Low Muscle Strength Malnutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ONS, Standard of Care (SOC).
Who it may be relevant to
Registry conditions: Low Muscle Strength, Malnutrition. Basic parameters: 55 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Dietary supplement ONS
    230 mL per serving, twice daily
  • Other Standard of Care (SOC)
    Dietary counseling and physical activity advice

Primary outcome measures

  • Change in body weight [Time frame: Day 0 to Day 180]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Thailand · 7 centers
  • 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

Identifiers

NCT: NCT07753239 · BL95

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗