- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610930
Is a Front-of-package Label Contaning Information on Both Nutrient Profile and Ultra-processing Well Understood?
May 10, 2023 updated by: Bernard Srour, University of Paris 13
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
21159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bobigny, France, 93017
- Equipe de recherche en Epidémiologie nutritionnelle
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Enrolled in the NutriNet-Santé cohort
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control arm
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.
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Experimental: Experimental arm
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
|
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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).
|
Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purchasing intentions
Time Frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
|
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.
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Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
|
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Product perceived as the healthiest
Time Frame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
|
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.
|
Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bernard Srour, PhD, PharmD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
July 7, 2022
Study Completion (Actual)
July 7, 2022
Study Registration Dates
First Submitted
October 28, 2022
First Submitted That Met QC Criteria
November 3, 2022
First Posted (Actual)
November 9, 2022
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 10, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- UParis13-BS
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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