HealthyNCT06488079
Effectiveness of Different Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet Among Italian Consumers
A study testing Summary Label, Nutrient-specific label and No label in people with Healthy, run by Donini Lorenzo M at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Summary Label, Nutrient-specific label and No label
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,029 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2024to 20 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- limited to participants older than 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet
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.
Read more
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
- Conditions
- Healthy
- Being tested
- Summary Label, Nutrient-specific label, No label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summary LabelOther
The Nutri-Score Front-of-Pack nutritional label
Nutrient-specific labelOther
The NutrInform Battery Front-of-Pack nutritional label
No labelOther
Conventional food educational flyer
| Study group | Role | What they receive |
|---|---|---|
| Nutri-Score label | Experimental | Not described Receives: Other: Summary Label |
| NutrInform Battery label | Experimental | Not described Receives: Other: Nutrient-specific label |
| No label | Sham comparator | Not described Receives: Other: No label |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start4 Jun 2024
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donini Lorenzo M
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor-investigator, Donini Lorenzo M, University of Roma La Sapienza
- Investigators
- Lorenzo Maria Donini, Principal investigator, Sapienza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488079
- Sponsor's protocol ID
- CERT_18F2F1CDB00
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: By decision of the ethics committee data can be shared only in an aggregated form
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet
- ClinicalTrials.gov ID
- NCT06488079
- Acronym / sponsor ID
- CERT_18F2F1CDB00
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,029 participants (actual)
- Lead sponsor
- Donini Lorenzo MUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 5 Jul 2024 (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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutri-Score label | Experimental | Other: Summary Label |
| NutrInform Battery label | Experimental | Other: Nutrient-specific label |
| No label | Sham comparator | Other: No label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- limited to participants older than 18 years
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Summary LabelThe Nutri-Score Front-of-Pack nutritional label | Other | Nutri-Score label |
| Nutrient-specific labelThe NutrInform Battery Front-of-Pack nutritional label | Other | NutrInform Battery label |
| No labelConventional food educational flyer | Other | No label |
Primary outcome
Adherence to the Mediterranean diet
Time frame: 30 days
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.
2 secondary outcomes
Nutrition Knowledge
Time frame: 30 days
Orthorexic behaviour
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No. By decision of the ethics committee data can be shared only in an aggregated form
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Lorenzo Maria Donini principal investigator
Sapienza University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summary Label, Nutrient-specific label and No label in people with Healthy, run by Donini Lorenzo M at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Adherence to the Mediterranean diet (time frame: 30 days). 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 5 Jul 2024.