EnergieShake 1.5kcal Complete Acceptability and Tolerance Study

Study Overview
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Brief Summary
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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
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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. Potential Benefits: Participants may gain weight or maintain their weight during the intervention. In the future, if this product becomes available on prescription, a wider variety of ONS available to patients may lessen taste fatigue associated with taking the same supplements over an extended period. STUDY OBJECTIVES Primary study objective: 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 a Test Oral Nutrition Supplement (EnergieShake® 1.5 kcal Complete, a nutritional supplement, classified as a Food for Special Medical Purposes for the dietary management of disease-related malnutrition) in patients requiring ONS. Secondary study objective: The secondary objective is to assess acceptability of the product. STUDY DESIGN This study is an open-label, prospective, controlled intervention in which participants act as their own controls. Guidance from ACBS requires that acceptability and tolerance studies must normally be carried out on at least 18 patients in the intended target group for a period of 1 week. The design of this study has been based on the guidance provided by ACBS. STUDY ENROLLMENT AND WITHDRAWAL Strategies for Recruitment and Retention: Potentially suitable participants will be identified by staff at the site. Participants who may be suitable are those who are currently taking ONS and whose requirement for ONS is expected to continue for at least a further 2 weeks. They will be approached by staff at the site and provided with a Participant Information Sheet and letter of invitation from the sponsor (Anaiah Healthcare Ltd). To ensure this process is free from undue influence, residents will not be coerced or offered inducements to participate. Subject Withdrawal Reasons for Withdrawal: Participants will have the choice of whether or not to withdraw from the study at any stage for any reason. Should the participant experience any adverse event or discomfort due to consuming the product, the participant will be advised to stop using the product. Handling of Subject Withdrawals or Subject Discontinuation of Study Intervention If the participant discontinues the study before the intervention is complete, their permission will be sought to use the data collected on the use of the product. A replacement of a participant who withdraws will be recruited to meet the requirement target that at least 18 patients provide data on the test ONS.

Official Title
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Open Label Study of Acceptability, Tolerance, and Compliance Using EnergieShake 1.5kcal Complete Nutritional Drink

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: EnergieShake 1.5kcal Complete


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EnergieShake 1.5 kcal Complete Intervention<br>Single am of intervention of ONS, EnergieShake 1.5 kcal Complete, in the open label study are to be given to participants for 8 days, i.e. two bottles twice daily. | Dietary Supplement: EnergieShake 1.5kcal Complete<br>* Participants will be given EnergieShake 1.5 kcal Complete drink twice daily. i.e. 2 bottles of ONS per day during the study period in place of their usual ONS. Participants will take their usual ONS for 2 days, followed by 8 day intervention on EnergieShake 1.5 kcal Complete drink.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance: how well the participant tolerates the ONS assessed by using the Bristol Stool Chart. | 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. | 10 days | 
| Compliance: how well the participant complies to the ONS assessed by a questionnaire. | 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. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How acceptable the ONS is to the participant assessed by using Hedonic scales questionnaire. | Assessment using Hedonic scales questionnaire rating taste/flavour, texture/consistency, aroma/smell, and taste/sweetness and overall acceptability on a scale from 9 (like extremely) to 1 (dislike extremely). | 10 days |