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Individual Food Preferences for the Mediterranean Diet in Cancer Patients - Trial NCT06058312

Access comprehensive clinical trial information for NCT06058312 through Pure Global AI's free database. This phase not specified trial is sponsored by Centre Antoine Lacassagne and is currently Recruiting. The study focuses on Neoplasms. Target enrollment is 442 participants.

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NCT06058312
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Trial Details
ClinicalTrials.gov โ€ข NCT06058312
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Individual Food Preferences for the Mediterranean Diet in Cancer Patients
Evaluation of Changes in Adherence to the Mediterranean Diet in Cancer Patients Undergoing Treatment

Study Focus

Neoplasms

Self-questionnaire

Interventional

other

Sponsor & Location

Centre Antoine Lacassagne

Nice, France

Timeline & Enrollment

N/A

Sep 04, 2023

Sep 04, 2024

442 participants

Primary Outcome

role of sensory alterations

Summary

This is an exploratory study aimed at characterizing adherence to the Mediterranean diet
 among patients undergoing treatment for cancer, in relation to sensory alterations that occur
 during treatment.
 
 The primary strength of this project lies in the consideration of a large number of variables
 that scientific literature has shown to play a significant role in the dietary behavior of
 patients. The project's multidisciplinary approach, which takes into account both sensory
 perception and psychological dimensions, can enrich scientific knowledge on the subject,
 enabling a better understanding of the dietary behaviors of cancer patients undergoing
 treatment.
 
 One of the main strengths of the project is that taste and smell reactivity will be tested
 using a combined approach that includes the evaluation of responses to PROP (Propylthiouracil
 - a bitter compound), selected aromas and odors, responses to model foods belonging to the
 Mediterranean diet in which the intensities of selected sensory properties are expected to be
 affected by chemotherapy (e.g., sweetness and freshness).
 
 To date, no study has investigated adherence to the Mediterranean diet in such a wide range
 of patients. The choice of a Mediterranean diet framework is based on evidence defining this
 type of diet as a health promoter, improving health and preventing diseases and health
 complications. The Mediterranean diet includes the food variety present in the specific
 region chosen for the study, ensuring variety and availability of local products. The
 selection of the Antoine Lacassagne Center in Nice is based on the need to study the dietary
 preferences of a Mediterranean population familiar with Mediterranean diet products.
 
 This project could serve as the foundation for a dietary development aspect, in which foods
 adapted to cancer patients will be created and tested to mitigate issues of malnutrition.
 
 Expected Benefits Addressing the scientific question regarding the impact of sensory and
 psychological variables on adherence to the Mediterranean Diet and dietary behavior of cancer
 patients undergoing treatment will help identify individual variables to consider in
 assisting patients in adopting health-promoting behavior and reducing malnutrition.
 
 Expected Risks The research project does not involve maneuvers or the implementation of care
 procedures other than those to which patients would be subjected if they were not
 participating in the study. This research involves no specific risks, except for possible
 risks of allergies or food intolerances related to the sensory testing session. The dietary
 models used only include food ingredients normally available in markets.
 
 In order to test the taste sensitivity index, the response to propylthiouracil (PROP) will be
 evaluated using paper discs previously soaked in a solution composed of water and PROP
 according to the method of Zhao et al. (2003). This procedure has been safely used in
 children as well as in several studies (including patients undergoing chemotherapy) approved
 by ethics committees in multiple institutes from various countries.
 
 Scientific Impact The project will provide information about the variables that impact the
 dietary behavior of patients undergoing chemotherapy. This knowledge will be useful in
 developing principles that contribute to reducing malnutrition rates in oncology patients.
 
 Methodology This is an exploratory study aimed at characterizing adherence to the
 Mediterranean diet among patients with cancer undergoing treatment, who may experience
 changes in their relationship with food as well as their dietary behavior. Adherence to the
 Mediterranean diet will be studied in cancer patients at T0 (before the start of treatment)
 and at T1 (after 9 weeks of treatment). A comparison will be made between patients without
 sensory alterations and patients with taste and/or smell alterations at T1. The psychological
 and sensory variables impacting dietary behavior will also be measured and correlated with
 adherence to the Mediterranean diet and the presence or absence of sensory alterations.

ICD-10 Classifications

Neoplasms
In situ neoplasms
Personal history of other neoplasms
Benign neoplasms
Malignant neoplasms

Data Source

ClinicalTrials.gov

NCT06058312

Non-Device Trial