EnergieShake® Acceptability and Tolerance Study

NCT02788032 | Unknown

• 1 other identifier: AHCES 005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Tolerance: how well the participant tolerates the Oral Nutritional Supplement, including changes to gastrointestinal symptoms.

  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.

  10 days

Secondary Outcomes (1)

• How acceptable the Oral Nutritional Supplement is to the participant, (taste, texture, aroma, consistency, etc.) Compliance with Oral Nutritional Supplement.

  10 days

Study Arms (1)

EnergieShake Intervention

OTHER

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

Interventions

EnergieShake oral supplement OTHER

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®

EnergieShake Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Anaiah Healthcare Pvt Ltd: lead

Study Sites (1)

Fermoyle Nursing Home

London, Surrey, KT15 1SH, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ryan Rodrigues, Masters

  Anaiah Healthcare Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce Sibiya

CONTACT

01932849023

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 24, 2016
• First Posted: June 2, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)