EnergieShake 1.5kcal Complete Acceptability and Tolerance Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: EnergieShake 1.5kcal Complete

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • London, Surrey, United Kingdom, KT15 1SH
      • Fermoyle Nursing Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EnergieShake 1.5 kcal Complete Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anaiah Healthcare Pvt Ltd
• Investigators: Principal Investigator: Ryan Rodrigues, BPharm, Anaiah Healthcare

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AHCES 006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes