Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer (U-TRANS)

Impact of a Mixed Intervention Aiming to Decrease the Consumption of Ultra-processed Foods on the Global Diet Quality in Individuals at High Risk of Cancer

The U-TRANS study was initiated by Gustave Roussy, which is its sponsor*. It is part of the Interception Program and aims to reduce the consumption of ultra-processed foods in order to improve the overall quality of the diet among people at high risk of cancer (WCRF score ≤ 5, corresponding to low adherence to nutritional cancer prevention recommendations: eating a diet rich in whole grains, vegetables, fruit and fibre, and limiting ultra-processed foods, red meat, processed meats, sugary drinks and alcohol). It assesses the impact of a digital intervention (based on the use of the Open Food Facts app) as a complement to the nutritional education provided by the Interception program.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Lynch Syndrome; Colon Cancer; Pancreas Cancer; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation
• Intervention / Treatment: Behavioral: educational workshop on nutrition + additional intervention on UPF tool and how to use it

Detailed Description

The consumption of ultra-processed foods (UPFs) has increased in our diet over the past 50 years. Their consumption is associated with poor nutritional profiles. In recent years, it has been associated with numerous pathologies, including obesity, diabetes, cardiovascular disease and, more recently, cancer.

An improvement in people's nutritional profiles (measured in particular by the internationally recognized WCRF score) is associated with a lower risk of cancer, whether in the general population or in people at high risk of cancer. However, changing dietary habits is not easy, especially over the long term, due to its cultural, economic and social components.

PO: To demonstrate whether an intervention aiming to decrease the consumption of UPF improves the global diet quality of individuals at high risk of different cancers.

SO.1 To compare the magnitude of change in UPF consumption between the two arms (simple education versus intervention with the Open Food Facts application), using a validated food frequency questionnaire designed to capture UPF exposure (Canadian questionnaire that will be adapted to the French population).

SO.2 To describe the change in frequency of use of the Open Food Facts application from baseline to 12 weeks in the intervention arm.

SO.3 To assess the determinants of changes in UPF consumption behaviors before and after the intervention.

SO.4 To identify factors associated with a greater improvement in global diet quality, a larger decrease in UPF consumption, and the observance of the UPF consumption including relevant clinical and demographic characteristics.

EO.1 To evaluate participants' attitudes towards UPF and the Open Food Facts application and investigate the relationship between these attitudes, food literacy, and UPF consumption behaviors.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Raynard, MD; Phone Number: +33 (0) 1 42 11 42 11; Email: bruno.raynard@gustaveroussy.fr
• Study Contact Backup: Name: Adeline Salasc, Pharm D; Phone Number: +33 (0) 1 42 11 42 11; Email: adeline.salasc@gustaveroussy.fr

Study Locations

• France
  • Avignon, France, 84918
    • Not yet recruiting
    • Institut Sainte Catherine
  • Rennes, France, 25042
    • Recruiting
    • Eugène Marquis
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18 years,
2. Individuals at increased risk of different cancers as defined within the Interception program,
3. With a baseline WCRF score ≤ 5 at entry in the Interception program,
4. Agreeing to participate and who have given their written agreement for the study,
5. Agreeing to fill in the questionnaires on the dedicated platform for the duration of the study,
6. Participant have and accept to use their smartphone,
7. All participants must understand spoken and written French language

Exclusion Criteria:

1. Psychiatric disorders or cognitive impairments precluding participation,
2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The patients will receive an educational workshop on nutrition and an additional intervention on UPF tool and how to use it	Behavioral: educational workshop on nutrition + additional intervention on UPF tool and how to use it; Participants with WCRF score at baseline ≤ 5 will be randomized at 1:1 ratio between intervention group (educational workshop on nutrition + additional intervention on UPF tool and how to use it) and control group (educational workshop on nutrition only). Impact will be assessed at 12 weeks with the WCRF questionnaire.
No Intervention: Control group; The patients will only receive en educational workshop on nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion (%) of participants with at least 1-point improvement in the WCRF score	The primary endpoint is the proportion (%) of participants with at least 1-point improvement in the WCRF score (ranging from 0 to 7 , the higher the healthier) at 12 weeks compared to baseline, in the intervention arm versus the control arm.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of UPF	The difference in the decrease of the UPF consumption score (ranging from 0 to 6, the lower - the lower consumption) between the two arms at 12 weeks (see SO.1)	week 12
Difference in the score of Open Food Facts application use	The difference in the increase of the ordinal scale score (ranging from 0 to 6, the higher the healthier) of Open Food Facts application use between the two arms at 12 weeks (see SO.2)	week 12
Difference of median for each behavioral determinants	The difference in the evolution of the 10-point Likert scale between the two arms at 12 weeks for each behavioral determinants (Capability, Opportunity, and Motivation) (see SO.3)	week 12
Association between the difference in UPF consumption score	The association between the difference in UPF consumption score between baseline and 12 weeks and behavioral determinants (see SO.3)	week 12
factors associated	The factors associated with the difference between baseline and 12 weeks (1) in the WCRF score, (2) in the UPF consumption score, and (3) in the observance of the UPF consumption, as measured by the 4th question of the questionnaire preliminary to the UPF questionnaire (see SO.4)	week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessments of participants' interview	Qualitative assessments of participants' interview	week 36

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Study Chair: Bruno Raynard, MD, Gustave Roussy, Villejuif, France

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Colonic Diseases; Skin Diseases; Breast Diseases; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Colonic Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: 2025-A00688-41; 2025/4135 (Other Identifier: CSET Number (Gustave Roussy ID))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No