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

Not Applicable

Completed

• Conditions: Taste, Altered; Oncology
• Interventions: Dietary Supplement: Fortimel/Nutridrink Compact Protein

• Registration Number: NCT05518825
• Lead Sponsor: Nutricia Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-29
• Study Start: 2022-10-06
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fortimel/Nutridrink Compact Protein	Fortimel/Nutridrink Compact Protein	Twice daily serving of the study product

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range	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	On 4 days	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	On 4 days

Trial Locations

Locations (1)

Nutricia Clinical Research Unit; 🇳🇱 Utrecht, Netherlands