The Oncoflavour Study

April 17, 2024 updated by: University Medical Center Groningen

Product Validation by Cancer Patients - Oncoflavour

Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help improve nutritional status. Commonly in cancer patients taste and smell alterations and side effects of treatment can affect the palatability and compliance to ONS. A variety of flavours and styles are available of ONS however research of the palatability of these in cancer patients is limited. This study aims to evaluate specific flavours created based on the taste changes occuring during treatment.

We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of flavour-sensations:

  • Warming/spicy sensation: to trigger the senses and bring new sensations
  • Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception
  • Neutral: to avoid that patients experience additional flavour and let them the opportunity to mix it with other food

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • > 18 years old
  • Ability to complete and comprehend questionnaires provided
  • Undergoing systemic cancer treatment (chemotherapy or concurrent chemoradiotherapy, radiotherapy, targeted therapy or immunotherapy)

Exclusion Criteria:

  • Uncertainty about the willingness or ability of the patient to comply with the protocol requirements (no impairment and no cognitive impairments)
  • Coexisting-morbidities affecting taste or smell function
  • Lactose Intolerance or Galactosaemia
  • Dysphagia
  • Diabetics
  • Food allergies/intolerances to ingredients present in the product
  • No rejection of lemon, red fruits, exotic fruit, yellow fruit flavours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taste of 5 flavors
  • Each patient will taste 5 products, in sequential-monadic test, randomized, one by one.
  • Patients will take few sips of each study product, ideally in isolation (avoid influence of other patients)
  • For each product tasted the subjects will be asked to answer a questionnaire including 1 question on the palatability of the product using a 10-point hedonic scale and a more detailed organoleptic evaluation of the product.
  • Between product tastings, participants will have a 10 minutes break to rinse their mouth and fill in a questionnaire assessing sensory changes
Other: Tasting of flavours
  • Each patient will taste 5 products, in sequential-monadic test, randomized, one by one.
  • Patients will take few sips of each study product, ideally in isolation (avoid influence of other patients)
  • For each product tasted the subjects will be asked to answer a questionnaire including 1 question on the palatability of the product using a 10-point hedonic scale and a more detailed organoleptic evaluation of the product.
  • Between product tastings, participants will have a 10 minutes break to rinse their mouth and fill in a questionnaire assessing sensory changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liking of 5 different oral nutritional supplements with adapted flavors
Time Frame: 20 minutes
To evaluate patient liking and perception about 5 new flavors on a 10-point scale via a sip test
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Nutricia, Inc.

Investigators

  • Principal Investigator: An KL Reyners, Prof, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2017

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 12, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 201700363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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