Breast CancerU-TRANSNCT07436312
Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer
A study testing educational workshop on nutrition + additional intervention on UPF tool and how to use it in people with Breast Cancer and Pancreas Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Pancreas Cancer, Colon Cancer
- What is being tested?
- educational workshop on nutrition + additional intervention on UPF tool and how to use it
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesFrance
- Study dates
- 4 May 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- Individuals at increased risk of different cancers as defined within the Interception program,
- 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 dedicated platform for the duration of the study,
- Participant have and accept to use their smartphone,
- All participants must understand spoken and written French language
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Institut Sainte Catherine
Avignon, 84918
- Recruiting
Eugène Marquis
Rennes, 25042
- Recruiting
Gustave Roussy
Villejuif, 94800
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Pancreas Cancer, Colon Cancer, Lynch Syndrome, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation
- Being tested
- educational workshop on nutrition + additional intervention on UPF tool and how to use it
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational workshop on nutrition + additional intervention on UPF tool and how to use itBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patients will receive an educational workshop on nutrition and an additional intervention on UPF tool and how to use it Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start4 May 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Raynard, MD, Study chair, Gustave Roussy, Villejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436312
- Sponsor's protocol ID
- 2025-A00688-41
- Other IDs
- 2025/4135
- Acronym
- U-TRANS
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07436312
- Acronym / sponsor ID
- U-TRANS / 2025-A00688-41
- Conditions
- Breast Cancer, Pancreas Cancer, Colon Cancer, Lynch Syndrome, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: educational workshop on nutrition + additional intervention on UPF tool and how to use itThe patients will receive an educational workshop on nutrition and an additional intervention on UPF tool and how to use it |
| Control group | No intervention | –The patients will only receive en educational workshop on nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years,
- Individuals at increased risk of different cancers as defined within the Interception program,
- 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 dedicated platform for the duration of the study,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational workshop on nutrition + additional intervention on UPF tool and how to use itParticipants 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. | Behavioural | Intervention group |
Primary outcome
Proportion (%) of participants with at least 1-point improvement in the WCRF score
Time frame: Week 12
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.
5 secondary outcomes
Consumption of UPF
Time frame: week 12
Difference in the score of Open Food Facts application use
Time frame: week 12
Difference of median for each behavioral determinants
Time frame: week 12
Association between the difference in UPF consumption score
Time frame: week 12
factors associated
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno Raynard, MD study chair
Gustave Roussy, Villejuif, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational workshop on nutrition + additional intervention on UPF tool and how to use it in people with Breast Cancer and Pancreas Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Raynard, MD (+33 (0) 1 42 11 42 11, bruno.raynard@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of participants with at least 1-point improvement in the WCRF score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.