Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.
Nutricia UK Ltd
100 participants
Sep 27, 2021
INTERVENTIONAL
Conditions
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 prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
Interventions
At baseline, the investigating dietitian/nurse will record several measures, including clinical history and symptoms over the previous 24 hours. In addition, patients who are already receiving an ONS will continue their prescribed ONS for 1 day in which their gastrointestinal tolerance, ONS compliance and acceptability will be recorded. All patients will then receive standardised dietary advice in addition to one of the four trial ONS products daily for 28 days. The type of ONS will be agreed with the patient and the investigating dietitian/nurse, and the ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The type of ONS prescribed will be the same throughout the 28 days and will be taken orally.
Locations(19)
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NCT05257980