Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058312
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-08-21
Brief Title:
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
Sponsor:
Centre Antoine Lacassagne
Organization:
Centre Antoine Lacassagne
Study Overview
Official Title:
Evaluation of Changes in Adherence to the Mediterranean Diet in Cancer Patients Undergoing Treatment
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyPrefMed
Brief 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 projects 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 eg 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 andor 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
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 projects 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 eg 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None