CClinicalTrials.gg
Active, not recruitingNCT06488079Updated Jul 5, 2024

Effectiveness of Different Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet Among Italian Consumers

An interventional study of Summary Label and Nutrient-specific label in Healthy, sponsored by Donini Lorenzo M. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Donini Lorenzo M · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
3,029
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to learn if Front-of-Pack labels, namely Nutri-Score and NutrInform Battery, work to improve adherence to the Mediterranean diet among healthy Italian adult participants. It will also learn about the label's ability to increase nutritional knowledge and participant's response in terms of orthorexic behaviour. The main questions it aims to answer are:

  • Does FOP nutritional labels work to guide participants' food choices towards healthier diets?
  • Do they increase participants\' nutritional knowledge?
  • To what extent are they related to obsessive focus on healthy eating, such as orthorexia nervosa? Researchers will compare the labels to a no label condition (in which participants were only given a conventional nutrition education flyer) to see if labels work to improve healthiness in individual diets.

Participants will:

  • Complete an initial questionnaire's battery
  • Use the assigned FOP label every day for 1 month to orient their food choices
  • Answer to final questionnaires
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Donini Lorenzo M is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • limited to participants older than 18 years

Exclusion criteria

Exclusion Criteria:

  • people currently on a diet for religious/ethical/personal choice or medical prescription
  • people with a degree or a professional expertise in the area of field, nutrition, and physical exercise
  • people who know one of the interventions
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
3,029 participants (actual)

Study arms

  • Experimental
    Nutri-Score label

    Other: Summary Label

  • Experimental
    NutrInform Battery label

    Other: Nutrient-specific label

  • Sham comparator
    No label

    Other: No label

Interventions

  • OtherSummary Label

    The Nutri-Score Front-of-Pack nutritional label

  • OtherNutrient-specific label

    The NutrInform Battery Front-of-Pack nutritional label

  • OtherNo label

    Conventional food educational flyer

06

What researchers measure

Primary outcomes

  1. Adherence to the Mediterranean diet

    The adherence is measured with the PREDIMED (PREvención con DIeta MEDiterránea) PLUS questionnaire adapted for the Italian population. The questionnaire asks about the frequency of consumption of traditional Mediterranean food (daily or weekly) by defining the portion size, or asking about the use of food with "yes or no" options, or identifying preferences between different food options. Possible values range from 0 to 17. Higher values correspond to a higher adherence.

    Time frame: 30 days

Secondary outcomes

  1. Nutrition Knowledge

    Nutrition knowledge is measured by the General Nutrition Knowledge Questionnaire (GNKQ) adapted for the Italian population (I-NK Questionnaire). It is composed of four sections exploring different aspects of NK: (NK1) Experts' recommendations (9 questions); (NK2) Food composition (10 questions); (NK3) Food choices and nutrition labels (11 questions); (NK4) Diet-disease associations (16 questions). Possible values range from 0 to 88. Higher values correspond to a higher knowledge.

    Time frame: 30 days

  2. Orthorexic behaviour

    Orthorexic behaviour is measured by the ORTO-R Questionnaire. The ORTO-R is an adaptation of the ORTO-15, from which it contains six items which were identified as the best markers of orthorexia nervosa. The response scale is a five-point Likert-type scale and a higher score reflects higher intensity of orthorexia nervosa thoughts and behaviors.

    Time frame: 30 days

07

Study locations

1 site
  • Sapienza University
    Roma, Rome 00185, Italy
08

References and documents

Individual participant data

Plan to share: No — By decision of the ethics committee data can be shared only in an aggregated form

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06488079
Lead sponsor
Donini Lorenzo M
Collaborators
Catholic University of the Sacred Heart
Responsible party
Donini Lorenzo M (Full Professor, University of Roma La Sapienza) — Sponsor-investigator
First posted
Jul 5, 2024
Start date
Jun 4, 2024
Primary completion
Jul 20, 2024 (estimated)
Completion
Jul 20, 2024 (estimated)
Last update
Jul 5, 2024

Study contacts

Lorenzo Maria Donini
principal investigator · Sapienza University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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