Tolerance and Acceptability of an Oral Nutrition Supplement

Condition(s) studied

Investigational drug(s) / intervention(s)

Oral nutritional supplementation: A Food for Special Medical Purposes taken orally, one or two servings a day as prescribed by the study dietitian, for 7 days.

Study summary

The goal of this study is to learn whether a new oral nutritional supplement is acceptable to adults who are malnourished, or at risk of malnutrition, and need nutritional support.

The main questions it aims to answer are:

* Do participants tolerate the supplement without stomach or bowel problems?
* How much of the prescribed supplement do participants take each day?
* How do participants rate the taste, texture and overall experience of taking the supplement?

Researchers will also record any side effects.

Participants will:

* Take the supplement every day for 7 days, as prescribed by their dietitian
* Keep a daily diary of how much they take and any stomach or bowel symptoms
* Complete a short questionnaire about the supplement and have a review with the study team on Day 7

Eligibility

Primary outcome measure(s)

• Gastrointestinal tolerance — Baseline and daily from Day 1 to Day 7
  Participants record gastrointestinal symptoms each day in a diary: nausea, vomiting, bloating, abdominal pain, constipation, diarrhoea, and burping or flatulence. Each symptom is rated none, mild, moderate or severe. Bowel movement frequency and stool type are recorded each day using the Bristol Stool Chart. Results are reported as how often each symptom occurs and how severe it is, compared with symptoms recorded at baseline.
• Compliance with the prescribed oral nutritional supplement — Daily from Day 1 to Day 7
  Participants record each day in a diary the number of servings prescribed and taken, and the reasons for any missed or partly taken servings. Compliance is reported as the percentage of prescribed servings each participant took over the study period.
• Palatability of the oral nutritional supplement — Day 7
  Participants complete a questionnaire rating appearance, smell, taste, texture, aftertaste, convenience and how pleasant the supplement is to take. Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Overall satisfaction is rated on a 5-point scale from 1 (very dissatisfied) to 5 (very satisfied).

Trial sites (1)

More Aymes International Limited trials in the UK

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