Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement (NCT07417514) | Clinical Trial Compass
RecruitingNot Applicable
Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
United Kingdom40 participantsStarted 2022-09-30
Plain-language summary
To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition, taken either orally or via a feeding tube
Who can participate
Age range18 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:
* Adult patients (ā„18 years) who are able to communicate clearly.
* Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
* Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
* Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
* Informed consent obtained.
Exclusion Criteria:
* Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
* Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
* No feeding tube for any patient taking the neutral variant.
* Patients with significant hepatic impairment.
* Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Any participant unable to give consent i.e., those with dementia.
* Participants under 18 years of age.
* Individuals who do not have sufficient proficiency with English language
* Investigator's uncertainty about the willingness or ability of the patient to complyā¦
What they're measuring
1
Acceptability and Palatability of Oral Nutrition Supplement