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

NCT05518825 | Completed

• 1 other identifier: SBB21R&36579
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oncology; Taste, Altered

Keywords

Oral nutritional supplement; Oncology; Taste alterations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (1)

Fortimel/Nutridrink Compact Protein

EXPERIMENTAL

Twice daily serving of the study product

Dietary Supplement: Fortimel/Nutridrink Compact Protein

Interventions

Fortimel/Nutridrink Compact Protein DIETARY_SUPPLEMENT

Twice daily serving of the study product

Fortimel/Nutridrink Compact Protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Nutricia Clinical Research Unit

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Neoplasms; Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 29, 2022
• Study Start: October 6, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)