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

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

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

Conditions
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Oncology, Taste, Altered

Intervention / Treatment
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* Dietary Supplement: Fortimel/Nutridrink Compact Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortimel/Nutridrink Compact Protein<br>Twice daily serving of the study product | Dietary Supplement: Fortimel/Nutridrink Compact Protein<br>* Twice daily serving of the study product<br>|

What is the study measuring?
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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 | 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 |  | 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 | 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 |  | On 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplement, Oncology, Taste alterations