Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial (NCT05257980) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
United Kingdom100 participantsStarted 2021-09-27
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Compliance with ONS prescription
Timeframe: Baseline (Day 1) - End of the study (Day 29)