NCT02796482

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 10, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

May 30, 2016

Last Update Submit

June 9, 2016

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (2)

  • Tolerance: how well the participant tolerates the ONS assessed by using the Bristol Stool Chart.

    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.

    10 days

  • Compliance: how well the participant complies to the ONS assessed by a questionnaire.

    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.

    10 days

Secondary Outcomes (1)

  • How acceptable the ONS is to the participant assessed by using Hedonic scales questionnaire.

    10 days

Study Arms (1)

EnergieShake 1.5 kcal Complete Intervention

OTHER

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

Interventions

EnergieShake 1.5kcal CompleteDIETARY_SUPPLEMENT

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.

EnergieShake 1.5 kcal Complete Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fermoyle Nursing Home

London, Surrey, KT15 1SH, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Ryan Rodrigues, BPharm

    Anaiah Healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Rodrigues

CONTACT

07889804593info@anaiahhealthcare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 10, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 10, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations

GB(1)