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Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement

ConditionDisease Related Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAymes International Limited

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Shot Style protein supplement

    Dietary 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Shot style protein supplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability and Palatability of Oral Nutrition Supplement

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.

Time frame
28 days
2

Gastro-Intestinal (GI) Tolerance

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

Time frame
7 days
3

Compliance

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.

Time frame
28 days

Secondary outcomes

1

Safety of consumption of Study Product

Daily assessment of GI symptoms

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aymes International Limited

Lead sponsor

Source ClinicalTrials.gov
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