EnergieShake® Acceptability and Tolerance Study
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|ClinicalTrials.gov 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
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|
|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® Dietary Powdered Supplement|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
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®
- 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.
- 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).
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): NCT02788032
|Contact: Joyce Sibiya||01932849023|
|Fermoyle Nursing Home|
|London, Surrey, United Kingdom, KT15 1SH|
|Contact: Joyce Sibiya 01932849023|
|Contact: Angela Partridge|
|Principal Investigator: Ryan Rodrigues, Masters|
|Principal Investigator:||Ryan Rodrigues, Masters||Anaiah Healthcare Ltd|