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EnergieShake 1.5kcal Complete Acceptability and Tolerance Study

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ClinicalTrials.gov Identifier: NCT02796482
Recruitment Status : Unknown
Verified May 2016 by Anaiah Healthcare Pvt Ltd.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Anaiah Healthcare Pvt Ltd

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.


Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: EnergieShake 1.5kcal Complete Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Open Label Study of Acceptability, Tolerance, and Compliance Using EnergieShake 1.5kcal Complete Nutritional Drink
Study Start Date : July 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. How acceptable the ONS is to the participant assessed by using Hedonic scales questionnaire. [ Time Frame: 10 days ]
    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).



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796482


Contacts
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Contact: Ryan Rodrigues 07889804593 info@anaiahhealthcare.com

Locations
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United Kingdom
Fermoyle Nursing Home
London, Surrey, United Kingdom, KT15 1SH
Sponsors and Collaborators
Anaiah Healthcare Pvt Ltd
Investigators
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Principal Investigator: Ryan Rodrigues, BPharm Anaiah Healthcare

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Responsible Party: Anaiah Healthcare Pvt Ltd
ClinicalTrials.gov Identifier: NCT02796482     History of Changes
Other Study ID Numbers: AHCES 006
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders