Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations (PREFER)

August 23, 2023 updated by: Nutricia Research
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands
        • Nutricia Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Being diagnosed with cancer
  2. Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
  3. Age > 18 years
  4. Written informed consent

Exclusion Criteria:

  1. Taste and smell alterations not caused by the cancer or anti-cancer treatment
  2. Galactosaemia
  3. Use of thickener to be able to swallow safely
  4. Allergies to any of the product ingredients or any of the flavours
  5. Current prescription for ONS, enteral nutrition or parenteral nutrition
  6. Diabetes mellitus Type I or Type II
  7. Open sores or severe inflammation in the mouth or throat
  8. Undergoing dialysis
  9. Hepatic encephalopathy
  10. Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
  11. Known pregnancy or lactation
  12. Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women or drug abuse in opinion of the investigator
  13. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  14. Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
  15. Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fortimel/Nutridrink Compact Protein
Twice daily serving of the study product
Dietary supplement: Fortimel/Nutridrink Compact Protein
Twice daily serving of the study product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
Time Frame: On 4 days
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
On 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range
Time Frame: On 4 days
On 4 days
Choice for the Fortimel/Nutridrink Compact Protein sensation flavours over the Fortimel/Nutridrink Compact Protein regular flavours between patients with and patients without Taste and Smell Alterations
Time Frame: On 4 days
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
On 4 days
Difference in average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour versus Fortimel/Nutridrink Compact Protein regular flavour between patients with and patients without Taste and Smell Alterations
Time Frame: On 4 days
On 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBB21R&36579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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