Disease Related Malnutrition
Conditions
Brief 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
Detailed description
To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. will be recorded. To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).
Interventions
DIETARY_SUPPLEMENTShot Style protein supplement
The Study product is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
Sponsors
Aymes International Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥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 comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Palatability of Oral Nutrition Supplement | 28 days | To assess the acceptability of the shot-style protein supplement in patients requiring oral nutritional supplementation. On day 7 and 28 of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new oral nutrition supplement. A 5 point hedonic scale will be used. |
| Gastro-Intestinal (GI) Tolerance | 7 days | To assess the GI tolerance of the shot-style protein supplement in patients with or at risk of disease related malnutrition, requiring additional protein, either fed orally or with a feeding tube. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days |
| Compliance | 28 days | To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of consumption of Study Product | 7 days | Daily assessment of GI symptoms |
Countries
United Kingdom
Outcome results
None listed