Objective Understanding of Nutritional LabelNCT05610930
Is a Front-of-package Label Contaning Information on Both Nutrient Profile and Ultra-processing Well Understood?
A study testing Front-of-pack label NutriScore 2.0 in people with Objective Understanding of Nutritional Label, run by University of Paris 13 at 1 site in France.
Trial summary
A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Objective Understanding of Nutritional Label
- What is being tested?
- Front-of-pack label NutriScore 2.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,159 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in the NutriNet-Santé cohort
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Equipe de recherche en Epidémiologie nutritionnelle
Bobigny, 93017
About this study
Official title: Effect of a New Graphically Modified Nutri-Score on the Objective Understanding of Foods' Nutritional Quality and Ultra-processing - a Randomised Controlled Trial
A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.
Read the detailed description
Two arms will be enrolled. The control arm will not have access to any FOP Label (the current situation in Europe), and the experimental arm will have access to Nutri-Score 2.0. Participants of both arms wil be asked to rank food products of 3 categories (breakfast cereals, cookies, ready-to-eat meals) according to their nutrient profile, and to identify ultra-processed foods.
- Being tested
- Front-of-pack label NutriScore 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Front-of-pack label NutriScore 2.0Other
Participants in the experimental arm can see, in case the product is ultra-processed, a black banner surrounding the Nutri-Score, with the word "ultra-transformé", meaning ultra-processed, and no black banner otherwise. Participants in the control arm had no label at all. The intervention (the Nutri-Score 2.0) was added on the packaging on the products included in the 3 sets of images that participants recieved via the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Participants received a questionnaire including 3 sets of images of food packaging, (brand blinded), categorized by food groups: 8 cookies, 7 breakfast cereals, and 7 ready-to-eat meals, but without front-of-pack nutritional label (in case the original Nutri-Score was displayed on the product, it was hidden by the investigators). They had the possibility to check the back-of-pack nutrition facts and ingredient information. First, they were asked which product they would intend to purchase in each category, and which product they thought to be the "healthiest". Then, participants were asked 1) to rank them according to their nutritional quality by identifying the first, the second and the third products with the best nutritional quality (in this order) and 2) to identify those that were ultra-processed. |
| Experimental arm | Experimental | Participants received a questionnaire including 3 sets of images of real food product packaging (brand blinded), categorized by food groups: 8 cookies, 7 breakfast cereals, and 7 ready-to-eat meals, with the Nutri-Score 2.0 displayed on the front-of-pack of each product. First, they were asked which product they would intend to purchase in each category, and which product they thought to be the "healthiest". Then, participants were asked 1) to rank them according to their nutritional quality by identifying the first, the second and the third products with the best nutritional quality (in this order) and 2) to identify those that were ultra-processed. Last, a series of questions evaluated how participants of this arm perceived the Nutri-Score 2.0 and whether they found it helpful. Receives: Other: Front-of-pack label NutriScore 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective understanding the nutritional quality.
The answers of the participants on the corresponding questionnaire (via the NutriNet-Santé website) were expected to match the order according to which Nutri-Score ranks the 3 products (highest nutritional quality, second highest, third highest). In case of ex-æquos (i.e., two products having the same Nutri-Score), both were considered correct. Therefore, the number of correct answers for the nutritional dimension could range between 0 (no correct answers) to 9 (3 best products*3 food categories, all correct answers).
Measured: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Objective understanding the ultra-processing dimension.
Participants were expected to identify all UPFs on the corresponding questionnaire (via the NutriNet-Santé website). For each product, the answer was considered correct if an UPF was identified as such by the participant (the gold standard being the presence of the black banner of the Nutri-Score 2.0, corresponding to the NOVA 4 "ultra-processed" definition), and a non-UPF was identified as such. Therefore, the number of correct answers for the food processing dimension could range between 0 (no correct answers) and 22 (correct answer for all 22 products).
Measured: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Secondary outcomes (2)
Purchasing intentions
Assessed with the question (in the corresponding questionnaire via the NutriNet-Santé website) : "Which of these products would you purchase more frequently?". This aimed to explore whether Nutri-Score 2.0 (the intervention) had an effect on the purchasing intentions.
Measured: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Product perceived as the healthiest
Assessed with the question (in the corresponding questionnaire via the NutriNet-Santé website) : "Which product seems the healthiest to you?". This aimed to explore whether Nutri-Score 2.0 (the intervention) had an effect on the product that the participants considered as the healthiest.
Measured: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 May 2022
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Objective Understanding of Nutritional LabelStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 13
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Srour, University of Paris 13
- Investigators
- Bernard Srour, PhD, PharmD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610930
- Sponsor's protocol ID
- UParis13-BS
- Status last verified
- May 2023
- First submitted
- 28 Oct 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srour B, Hercberg S, Galan P, Monteiro CA, Szabo de Edelenyi F, Bourhis L, Fialon M, Sarda B, Druesne-Pecollo N, Esseddik Y, Deschasaux-Tanguy M, Julia C, Touvier M. Effect of a new graphically modified Nutri-Score on the objective understanding of foods' nutrient profile and ultraprocessing: a randomised controlled trial. BMJ Nutr Prev Health. 2023 Jun;6(1):108-118. doi: 10.1136/bmjnph-2022-000599. Epub 2023 Jun 8.
PubMed 37484539
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New Graphically Modified Nutri-Score on the Objective Understanding of Foods' Nutritional Quality and Ultra-processing - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05610930
- Acronym / sponsor ID
- UParis13-BS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,159 participants (actual)
- Lead sponsor
- University of Paris 13University, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 9 Nov 2022 (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.
A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.
Detailed description
Two arms will be enrolled. The control arm will not have access to any FOP Label (the current situation in Europe), and the experimental arm will have access to Nutri-Score 2.0. Participants of both arms wil be asked to rank food products of 3 categories (breakfast cereals, cookies, ready-to-eat meals) according to their nutrient profile, and to identify ultra-processed foods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Participants received a questionnaire including 3 sets of images of food packaging, (brand blinded), categorized by food groups: 8 cookies, 7 breakfast cereals, and 7 ready-to-eat meals, but without front-of-pack nutritional label (in case the original Nutri-Score was displayed on the product, it was hidden by the investigators). They had the possibility to check the back-of-pack nutrition facts and ingredient information. First, they were asked which product they would intend to purchase in each category, and which product they thought to be the "healthiest". Then, participants were asked 1) to rank them according to their nutritional quality by identifying the first, the second and the third products with the best nutritional quality (in this order) and 2) to identify those that were ultra-processed. |
| Experimental arm | Experimental | Other: Front-of-pack label NutriScore 2.0Participants received a questionnaire including 3 sets of images of real food product packaging (brand blinded), categorized by food groups: 8 cookies, 7 breakfast cereals, and 7 ready-to-eat meals, with the Nutri-Score 2.0 displayed on the front-of-pack of each product. First, they were asked which product they would intend to purchase in each category, and which product they thought to be the "healthiest". Then, participants were asked 1) to rank them according to their nutritional quality by identifying the first, the second and the third products with the best nutritional quality (in this order) and 2) to identify those that were ultra-processed. Last, a series of questions evaluated how participants of this arm perceived the Nutri-Score 2.0 and whether they found it helpful. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in the NutriNet-Santé cohort
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Front-of-pack label NutriScore 2.0Participants in the experimental arm can see, in case the product is ultra-processed, a black banner surrounding the Nutri-Score, with the word "ultra-transformé", meaning ultra-processed, and no black banner otherwise. Participants in the control arm had no label at all. The intervention (the Nutri-Score 2.0) was added on the packaging on the products included in the 3 sets of images that participants recieved via the questionnaire. | Other | Experimental arm |
Primary outcome
Objective understanding the nutritional quality.
Time frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
The answers of the participants on the corresponding questionnaire (via the NutriNet-Santé website) were expected to match the order according to which Nutri-Score ranks the 3 products (highest nutritional quality, second highest, third highest). In case of ex-æquos (i.e., two products having the same Nutri-Score), both were considered correct. Therefore, the number of correct answers for the nutritional dimension could range between 0 (no correct answers) to 9 (3 best products*3 food categories, all correct answers).
Objective understanding the ultra-processing dimension.
Time frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Participants were expected to identify all UPFs on the corresponding questionnaire (via the NutriNet-Santé website). For each product, the answer was considered correct if an UPF was identified as such by the participant (the gold standard being the presence of the black banner of the Nutri-Score 2.0, corresponding to the NOVA 4 "ultra-processed" definition), and a non-UPF was identified as such. Therefore, the number of correct answers for the food processing dimension could range between 0 (no correct answers) and 22 (correct answer for all 22 products).
2 secondary outcomes
Purchasing intentions
Time frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Product perceived as the healthiest
Time frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 37484539Srour B, Hercberg S, Galan P, Monteiro CA, Szabo de Edelenyi F, Bourhis L, Fialon M, Sarda B, Druesne-Pecollo N, Esseddik Y, Deschasaux-Tanguy M, Julia C, Touvier M. Effect of a new graphically modified Nutri-Score on the objective understanding of foods' nutrient profile and ultraprocessing: a randomised controlled trial. BMJ Nutr Prev Health. 2023 Jun;6(1):108-118. doi: 10.1136/bmjnph-2022-000599. Epub 2023 Jun 8.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Bernard Srour, PhD, PharmD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Front-of-pack label NutriScore 2.0 in people with Objective Understanding of Nutritional Label, run by University of Paris 13 at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective understanding the nutritional quality. (time frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610930, which also lists 1 linked publication.
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 12 May 2023.