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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
      • Bobigny, France, 93017
        • Equipe de recherche en Epidémiologie nutritionnelle

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other: Front-of-pack label NutriScore 2.0
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Paris 13

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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