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EnergieShake 1.5kcal Complete Acceptability and Tolerance Study

NCT02796482 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-06-10

No results posted yet for this study

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.

Conditions

  • Malnutrition

Interventions

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.

Sponsors & Collaborators

  • Anaiah Healthcare Pvt Ltd

    lead INDUSTRY

Principal Investigators

  • Ryan Rodrigues, BPharm · Anaiah Healthcare

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796482 on ClinicalTrials.gov