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OpenTrials
Completed

NCT Number: NCT05518825

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutricia Clinical Research Unit

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortimel/Nutridrink Compact Protein

Dietary Supplement

Twice daily serving of the study product

Primary outcomes

  1. Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour

    Time frame: On 4 days

    Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.

Secondary outcomes

  1. 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

  2. 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

    Time frame: On 4 days

    Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.

  3. 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

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: PREFER

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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