MalnutritionNCT02796482
EnergieShake 1.5kcal Complete Acceptability and Tolerance Study
A study testing EnergieShake 1.5kcal Complete in people with Malnutrition, run by Anaiah Healthcare Pvt Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- EnergieShake 1.5kcal Complete
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- EnergieShake 1.5kcal Complete
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnergieShake 1.5kcal CompleteDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| EnergieShake 1.5 kcal Complete Intervention | Other | 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. Receives: Dietary Supplement: EnergieShake 1.5kcal Complete |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 days
Secondary outcomes (1)
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).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anaiah Healthcare Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Rodrigues, BPharm, Principal investigator, Anaiah Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796482
- Sponsor's protocol ID
- AHCES 006
- Status last verified
- May 2016
- First submitted
- 30 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of Acceptability, Tolerance, and Compliance Using EnergieShake 1.5kcal Complete Nutritional Drink
- ClinicalTrials.gov ID
- NCT02796482
- Acronym / sponsor ID
- AHCES 006
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Anaiah Healthcare Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnergieShake 1.5 kcal Complete Intervention | Other | Dietary Supplement: EnergieShake 1.5kcal CompleteSingle 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnergieShake 1.5kcal CompleteParticipants 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. | Dietary supplement | EnergieShake 1.5 kcal Complete Intervention |
Primary outcome
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.
1 secondary outcome
How acceptable the ONS is to the participant assessed by using Hedonic scales questionnaire.
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Rodrigues, BPharm principal investigator
Anaiah Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnergieShake 1.5kcal Complete in people with Malnutrition, run by Anaiah Healthcare Pvt Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan Rodrigues (07889804593, info@anaiahhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance: how well the participant tolerates the ONS assessed by using the Bristol Stool Chart. (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.