Open Label Study of Acceptability, Tolerance, and Compliance Using EnergieShake 1.5kcal Complete Nutritional Drink
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Tolerance: how well the participant tolerates the ONS assessed by using the Bristol Stool Chart.
Study Overview
Brief Summary
This open-label, prospective, controlled intervention study involves evaluating tolerance and acceptability of an Oral Nutrition Supplement (ONS; EnergieShake® 1.5 kcal Complete drink) in 18 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 18 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.
Potential Risks and Benefits
Potential Risks: There are no anticipated risks to participants. Participants will already be taking other ONS as this is one of the inclusion criteria. Minimal inconvenience to participants is anticipated as they will be asked to complete a questionnaire on the product's acceptability. Daily records on the GI tolerance of the product will be recorded by participants or nursing staff. Most of the study documentation will be completed by the study staff.
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 ONS assessed by using the Bristol Stool Chart.
Time Frame: 10 days
The primary objective of this study is to assess gastrointestinal (GI) tolerance. This is assessed by using the Bristol Stool Chart to check the tolerance of the ONS.
Compliance: how well the participant complies to the ONS assessed by a questionnaire.
Time Frame: 10 days
The second outcome is assessed by a questionnaire asking participants to give feedback on any discomfort such as present nausea, vomiting, burping, flatulence, wind, discomfort, due to consumption of the ONS.
Secondary Outcomes
- How acceptable the ONS is to the participant assessed by using Hedonic scales questionnaire.(10 days)