Open Label Study of Acceptability, Tolerance, and Compliance Using EnergieShake® Dietary Powdered Supplement
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Tolerance: how well the participant tolerates the Oral Nutritional Supplement, including changes to gastrointestinal symptoms.
Study Overview
Brief Summary
This open-label, prospective, controlled intervention study involves evaluating tolerance and acceptability of an Oral Nutrition Supplement (ONS; EnergieShake®) in 16 adult patients who are already taking an ONS. Following a 2-day baseline data collection on their current ONS, patients switch to the test ONS, which is taken for a further 8 consecutive days. Patients revert to their current ONS at the end of the study. Patients act as their own controls and thus all patients are allocated the same intervention.
Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept for participants throughout the study period. Participants' height and weight will be collected at baseline (weight at end will also be collected), all medications will be documented, and relevant medical and dietary histories will be recorded. A questionnaire at the end of the intervention period will be administered collecting participants' views on the acceptability (taste and palatability) of the test ONS. Taste and palatability will be assessed via a questionnaire that uses a Hedonic scale to quantify preference.
Detailed Description
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
Background Information
This open-label study involves evaluating tolerance and acceptability of the test ONS in 16 adult participants who are already taking an ONS. Following a 2-day baseline data collection on their current ONS, patients switch to the test ONS, which is taken for a further 8 consecutive days. Patients revert to their current ONS at the end of the study. Patients act as their own controls and thus all patients are allocated the same intervention.
Rationale
Patient tolerance and acceptability is fundamental to the successful use of an ONS. Acceptability and tolerance studies for ONS are required by the Advisory Committee on Borderline Substances (ACBS) as part of a submission for a new product to be made available at NHS expense in the community.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (18 years or older)
- •Participants with or at risk of malnutrition who are already taking ONS on a daily basis
- •Participants expected to continue to require ONS for at least a further 2 weeks
- •Participants able to give their informed consent to participate
Exclusion Criteria
- •Requirement of tube or parenteral nutrition.
- •Participants receiving palliative care.
- •Participants with chronic renal disease or liver failure.
- •Participants requiring a milk/lactose free diet
- •Participants with significant on-going gastrointestinal symptoms.
Outcomes
Primary Outcomes
Tolerance: how well the participant tolerates the Oral Nutritional Supplement, including changes to gastrointestinal symptoms.
Time Frame: 10 days
The primary objective of the study is to assess gastrointestinal (GI) tolerance (bowel frequency and consistency using the Bristol Stool Chart, nausea, vomiting, abdominal discomfort, wind, burping, flatulence) to test Oral Nutrition Supplement (EnergieShake®, a powdered nutritional supplement, classified as a Food for Special Medical Purposes for the dietary management of disease-related malnutrition) in patients requiring ONS.
Secondary Outcomes
- How acceptable the Oral Nutritional Supplement is to the participant, (taste, texture, aroma, consistency, etc.) Compliance with Oral Nutritional Supplement.(10 days)