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

Oncology Clinical Trial

— PREFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518825
• Other study ID #: SBB21R&36579
• Status: Completed
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: August 2023
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysgeusia
• Oncology
• Taste, Altered

Intervention

Dietary Supplement:
• Fortimel/Nutridrink Compact Protein
Twice daily serving of the study product

Locations

Country	Name	City	State
Netherlands	Nutricia Clinical Research Unit	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	On 4 days
Secondary	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
Secondary	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.	On 4 days
Secondary	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