NCT05518825

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 10, 2022

Last Update Submit

August 23, 2023

Conditions

OncologyTaste, Altered

Keywords

Oral nutritional supplementOncologyTaste 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 ProteinDIETARY_SUPPLEMENT

Twice daily serving of the study product

Fortimel/Nutridrink Compact Protein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutricia Clinical Research Unit

Utrecht, Netherlands

Location

MeSH Terms

Conditions

NeoplasmsDysgeusia

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological 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)