Status:
RECRUITING
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
Lead Sponsor:
Nutricia UK Ltd
Conditions:
Malnutrition
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospect...
Detailed Description
Disease-related malnutrition (DRM) is a highly prevalent condition which leads to significant adverse health and economic burden. For the management of patients with DRM, oral nutritional supplements ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05257980
Start Date
September 27 2021
End Date
December 31 2026
Last Update
February 26 2025
Active Locations (19)
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1
Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford, United Kingdom
2
West Walk Surgery
Bristol, United Kingdom
3
Rowden Surgery
Chippenham, United Kingdom
4
Sirona Care & Health
Clevedon, United Kingdom