EnergieShake 1.5kcal Complete Acceptability and Tolerance Study
|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
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|
|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|
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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796482
|Contact: Ryan Rodriguesemail@example.com|
|Fermoyle Nursing Home|
|London, Surrey, United Kingdom, KT15 1SH|
|Principal Investigator:||Ryan Rodrigues, BPharm||Anaiah Healthcare|