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

Primary Purpose

Oncology, Taste, Altered

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fortimel/Nutridrink Compact Protein
Sponsored by
Nutricia Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oncology focused on measuring Oral nutritional supplement, Oncology, Taste alterations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nutricia Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fortimel/Nutridrink Compact Protein

Arm Description

Twice daily serving of the study product

Outcomes

Primary Outcome Measures

Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.

Secondary Outcome Measures

Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range
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
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
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

Full Information

First Posted
August 10, 2022
Last Updated
August 23, 2023
Sponsor
Nutricia Research
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1. Study Identification

Unique Protocol Identification Number
NCT05518825
Brief Title
Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations
Acronym
PREFER
Official Title
Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Taste, Altered
Keywords
Oral nutritional supplement, Oncology, Taste alterations

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fortimel/Nutridrink Compact Protein
Arm Type
Experimental
Arm Description
Twice daily serving of the study product
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortimel/Nutridrink Compact Protein
Intervention Description
Twice daily serving of the study product
Primary Outcome Measure Information:
Title
Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
Description
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
Time Frame
On 4 days
Secondary Outcome Measure Information:
Title
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
Title
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
Description
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
Time Frame
On 4 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with cancer Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months. Age > 18 years Written informed consent Exclusion Criteria: Taste and smell alterations not caused by the cancer or anti-cancer treatment Galactosaemia Use of thickener to be able to swallow safely Allergies to any of the product ingredients or any of the flavours Current prescription for ONS, enteral nutrition or parenteral nutrition Diabetes mellitus Type I or Type II Open sores or severe inflammation in the mouth or throat Undergoing dialysis Hepatic encephalopathy Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort Known pregnancy or lactation 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 Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study. Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
Facility Information:
Facility Name
Nutricia Clinical Research Unit
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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