Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial

Launched by NUTRICIA UK LTD · Feb 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying four new ready-to-drink nutritional supplements designed for adults who are malnourished or at risk of becoming malnourished. The goal is to see how well people tolerate these supplements, how much they enjoy them, and whether they help improve appetite and nutritional health. Participants will take one of the supplements daily for 28 days while continuing with their regular meals.

To join the study, you need to be at least 16 years old and identified as being malnourished based on a specific screening tool. You also need to be willing to drink one bottle of the supplement each day. Unfortunately, this study is not suitable for people who are receiving certain types of specialized nutrition through tubes, have severe liver or kidney problems, or are undergoing certain cancer treatments that might affect their ability to participate. If you choose to take part, you'll be monitored over the 28 days to ensure everything is going well. Your participation could help improve nutritional options for people in similar situations!

Gender

ALL

Eligibility 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.