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Evaluation of new ready-to-drink nutritional supplements for malnutrition

Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.

Not applicable Interventional Nutricia UK Ltd · NCT05257980

This study is testing four new ready-to-drink nutritional supplements to see if they can help people who are malnourished or at risk of malnutrition improve their nutrient intake and overall well-being.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages16 Years and up
SexAll
SponsorNutricia UK Ltd Industry-sponsored
Locations19 sites (Ashford and 18 other locations)
Trial IDNCT05257980 on ClinicalTrials.gov

What this trial studies

This study evaluates the compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready-to-drink oral nutritional supplements (ONS) over a 28-day period. Participants, identified as malnourished or at risk of malnutrition, will receive one of the ONS daily alongside their regular diet. The study aims to address issues of poor compliance often seen with ONS due to factors like taste fatigue and volume requirements. By improving nutritional intake, the study seeks to enhance patient outcomes and quality of life.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 and older who are identified as malnourished or at risk of malnutrition and are expected to consume at least one bottle of ONS daily.

Not a fit: Patients receiving parenteral nutrition, those with major hepatic or renal dysfunction, and cancer patients experiencing significant gastrointestinal disturbances may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional management for patients suffering from malnutrition, enhancing their recovery and overall health.

How similar studies have performed: Previous studies have shown that oral nutritional supplements can effectively manage malnutrition, indicating a potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female
* ≥16 years of age
* Identified as being malnourished/at risk of malnutrition by malnutrition screening tools \[i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan\]
* Expected to receive at least one bottle of ONS per day
* Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign

Exclusion Criteria:

* Patients receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
* Patients with major hepatic dysfunction (i.e., decompensated liver disease)
* Patients with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\]
* Cancer patients likely to anticipate significant gastrointestinal disturbances/taste changes as a result of Systemic Anti-Cancer Therapy (SACT)
* Patients with active/chronic gastrointestinal disease or impaired gastrointestinal function
* Patients with significant dysphagia/high aspiration risk
* Participation in other clinical intervention studies within 1 month of this study
* Adults lacking mental capacity to consent
* Allergy to any study product ingredients
* Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Where this trial is running

Ashford and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Malnutrition
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.