Oncology, Taste, Altered
Conditions
Keywords
Oral nutritional supplement, Oncology, Taste alterations
Brief summary
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations
Interventions
DIETARY_SUPPLEMENTFortimel/Nutridrink Compact Protein
Twice daily serving of the study product
Sponsors
Nutricia Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed