Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shot Style protein supplement.
- Who it may be relevant to
- Registry conditions: Disease Related Malnutrition. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Tolerance and Acceptability Evaluation of AYMES Protein Shot
Overview
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 supplement Shot 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.
Primary outcome measures
- Acceptability and Palatability of Oral Nutrition Supplement [Time frame: 28 days]
- Gastro-Intestinal (GI) Tolerance [Time frame: 7 days]
- Compliance [Time frame: 28 days]
Secondary outcome measures (1)
- Safety of consumption of Study Product [Time frame: 7 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- UCLH NHS Foundation Trust — London
Identifiers
NCT: NCT07417514 · AY:PS01