Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer

NCT07436312 | Not Yet Recruiting

• 2 other identifiers: 2025-A00688-412025/4135
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Pancreas Cancer; Colon Cancer; Lynch Syndrome; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Consumption of UPF

  week 12

• Difference in the score of Open Food Facts application use

  week 12

• Difference of median for each behavioral determinants

  week 12

• Association between the difference in UPF consumption score

  week 12

• factors associated

  week 12

Other Outcomes (1)

• Qualitative assessments of participants' interview

  week 36

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The patients will only receive en educational workshop on nutrition

Interventions

educational workshop on nutrition + additional intervention on UPF tool and how to use it BEHAVIORAL

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years,
• Individuals at increased risk of different cancers as defined within the Interception program,
• Individuals who have completed a face-to-face nutrition class currently on the breast, pancreas, Lynch, Harvey pathways,
• With a baseline WCRF score ≤ 5 at entry in the Interception program,
• Agreeing to participate and who have given their written agreement for the study,
• Agreeing to fill in the questionnaires on the MyInterception and Nutrifast platform for the duration of the study,
• Participant have and accept to use their smartphone,
• All participants must understand spoken and written French language

You may not qualify if:

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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms; Colonic Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bruno Raynard, MD

  Gustave Roussy, Villejuif, France

  STUDY CHAIR

Central Study Contacts

Bruno Raynard, MD

CONTACT

+33 (0) 1 42 11 42 11; bruno.raynard@gustaveroussy.fr

Adeline Salasc, Pharm D

CONTACT

+33 (0) 1 42 11 42 11; adeline.salasc@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 cohorts: intervention group (educational workshop on nutrition + additional intervention on UPF tool and how to use it) and control group (educational workshop on nutrition only).

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)