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EnergieShake® Acceptability and Tolerance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02788032
Recruitment Status : Unknown
Verified May 2016 by Anaiah Healthcare Pvt Ltd.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2016
Last Update Posted : June 2, 2016
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®) in 16 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 Other: EnergieShake oral supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Open Label Study of Acceptability, Tolerance, and Compliance Using EnergieShake® Dietary Powdered Supplement
Study Start Date : July 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
EnergieShake Intervention
Single arm of intervention of Oral Nutritional Supplement in the open label study to be given to participants for 8 days Two 57g sachets of EnergieShake daily to be given to participants during the 8 day intervention period.
Other: EnergieShake oral supplement
The participants will be given EnergieShake® powdered nutritional supplement twice daily during the study period in place of their usual ONS. Participants will take their usual ONS for 2 days followed by an 8 day intervention on EnergieShake®

Primary Outcome Measures :
  1. Tolerance: how well the participant tolerates the Oral Nutritional Supplement, including changes to gastrointestinal symptoms. [ Time Frame: 10 days ]
    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 test Oral Nutrition Supplement (EnergieShake®, a powdered nutritional supplement, classified as a Food for Special Medical Purposes for the dietary management of disease-related malnutrition) in patients requiring ONS.

Secondary Outcome Measures :
  1. How acceptable the Oral Nutritional Supplement is to the participant, (taste, texture, aroma, consistency, etc.) Compliance with Oral Nutritional Supplement. [ Time Frame: 10 days ]
    Assessment on Taste Questionnaire used asks patients to rate appearance, taste/flavour, texture/consistency, Aroma/smell, Taste/sweetness, and overall acceptability using Hedonic scale: 9 (like extremely) to 1 (dislike extremely).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT02788032

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Contact: Joyce Sibiya 01932849023

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United Kingdom
Fermoyle Nursing Home
London, Surrey, United Kingdom, KT15 1SH
Contact: Joyce Sibiya    01932849023      
Contact: Angela Partridge         
Principal Investigator: Ryan Rodrigues, Masters         
Sponsors and Collaborators
Anaiah Healthcare Pvt Ltd
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Principal Investigator: Ryan Rodrigues, Masters Anaiah Healthcare Ltd
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Responsible Party: Anaiah Healthcare Pvt Ltd Identifier: NCT02788032    
Other Study ID Numbers: AHCES 005
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nutrition Disorders