Dietary HabitsNCT05789238
Development of Online Store for Testing Regulatory Food and Nutrition Policies in Brazil
A study testing ANVISA and PAHO in people with Dietary Habits, run by University of North Carolina, Chapel Hill at 1 site in Brazil.
Trial summary
The purpose of this randomized controlled trial is to assess the impact of different nutrient profiles for magnifying glass front-of-package labels (FOPLs) on consumer choices in an online grocery store. Participants will be adults residing in Brazil recruited through a survey research firm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- ANVISA and PAHO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,026 participants
- Where
- 1 siteBrazil
- Study dates
- 24 May 2023to 28 Jun 2023
- 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
- 18 years or older
- Resides in Brazil
- Does at least half of the grocery shopping for their household
Who cannot join
- Involved in any pre-testing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized controlled trial is to assess the impact of different nutrient profiles for magnifying glass front-of-package labels (FOPLs) on consumer choices in an online grocery store. Participants will be adults residing in Brazil recruited through a survey research firm. Participants will be randomly assigned to one of three shopping environments in an online grocery store. Participants will complete a shopping task (selecting items from a pre-specified shopping list) in the online grocery store. After completing the shopping task, participants will be rerouted to a computer survey. The survey will include standard behavior and label perception questions, as well as demographic items.
Read the detailed description
Among noncommunicable disease, cardiovascular-related diseases are the leading cause of death worldwide and contribute to almost one-third of deaths in Brazil. Cardiovascular disease has become the leading cause of death in Brazil since 1960 due in part to poor eating habits, obesity, and insufficient physical activity. Consumption of high levels of sodium, added sugar, and saturated fat is a major driver of the development of cardiovascular disease. In this context, nutrition policies and interventions, such as the use of warning labels, are an important tool for reducing risk of diet-related diseases. The Brazilian Ministry of Health has recently announced efforts to combat the country's growing burden of diet-related noncommunicable diseases, and Brazil's National Health Surveillance Agency (ANVISA) has approved a more transparent and accessible system for communicating nutrition information for foods and beverages. The proposal will require labeling with a magnifying glass symbol on the front of products' packages to inform consumers about excess nutrients (i.e., sodium, sugar, saturated fat). Similar interventions have been implemented across Latin America, including Chile, Peru, and Mexico. A recent study in Chile demonstrated a reduction in purchases of food and drink items displaying warning labels.
This study seeks to test the effectiveness of different nutrient profiles to determine which products should carry the new labels in Brazil (i.e., the Pan-American Health Organization's profile or Brazil's National Health Surveillance Agency's proposed profile). Additionally, it seeks to assess whether the inclusion of information about products' ultra-processed nature further impacts consumers' product perceptions. The study will provide critical information for the Brazilian Ministry of Health on the effectiveness of the new label proposal and on strategies to inform Brazilians of product healthfulness.
Participants will be initially redirected from Cint (an online panel company). Following online consent and completion of a screening survey, participants will be redirected to an experimental online grocery store (Saruê), given a shopping list, and asked to shop for the items on the list as if in a real store. Upon redirection from Cint, participants will be randomly assigned into three arms: 1) control (no FOPLs); 2) FOPLs applied to products based on Brazil's National Health Surveillance Agency (ANVISA)'s nutrient profile model; or 3) front-of-package labels applied to products based on the Pan-American Health Organization (PAHO)'s nutrient profile model. After participants select products and check out, they will answer a survey about their perceptions about the labels and products carrying them. These questions will include self-reported responses to the content (e.g., elaboration, beliefs). After data collection, data on participants' selected products in the online grocery store will be analyzed to determine which nutrient profile was the most effective in decreasing participants' consumption of key nutrients.
Setting: The trial will take place in Saruê, an experimental online grocery store created for researchers to examine how front-of-package labels influence consumer purchases in a controlled but realistic environment. The online store reflects real-world prices and is modeled after Pão de Açúcar, a Brazilian online grocery store .
Recruitment: Participants will be recruited through Cint, a survey research firm. The eligibility criteria are residing in Brazil, being 18 years or older, and being responsible for at least half of the grocery shopping for one's household. Participants are ineligible if they were involved in any pre-testing related to the survey. Experiments conducted using online convenience samples, such as those recruited by Cint, largely replicate findings from studies conducted via probability-based samples. Cint will screen for eligibility and recruit participants from their pool of 8 million participants in Brazil. Approximately 3,000 participants will be recruited. As compensation, participants will receive incentives or points that can be redeemed for gift cards or goods per Cint's protocols.
Informed Consent: Participants will sign an informed consent form that follows a structure that is customary in Brazil.
Randomization: After the participant has signed the consent form, they will be randomly assigned to one of the three study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to each trial arm.
- Conditions
- Dietary Habits
- Being tested
- ANVISA, PAHO
- Keywords
- front-of-package labels, ANVISA, PAHO
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANVISABehavioural
Products carrying front-of-package labels based on Brazil's Health Regulatory Agency (ANVISA's) nutrient profile model
PAHOBehavioural
Products carrying front-of-package labels based on the Pan-American Health Organization (PAHO's) nutrient profile model
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No labels for products high in added sugar, saturated fat, or sodium |
| ANVISA | Experimental | Levels of added sugars, saturated fat, and sodium, if exceeded according to the Brazil Nutrient Profile Model, will require the magnifying glass FOPL below on the front of the package for either solid food or liquid food. Receives: Behavioral: ANVISA |
| PAHO | Experimental | PAHO Model is not based on thresholds (cut-off limits), but by percentage of regulated nutrient values in total calories amount and by NOVA categories. Therefore, the Brazil team has classified products from the dataset into NOVA categories and created calculations to apply the PAHO model to PdeA products. Receives: Behavioral: PAHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sugar purchased
Total grams of sugar of products in a participant's shopping basket. This will be calculated by adding together the total sugar from each product in the participant's shopping basket. Sugar for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Measured: At completion of ~20 minute shopping task
Total saturated fat purchased
Total grams of saturated fat of products in a participant's shopping basket. This will be calculated by adding together the total saturated fat from each product in the participant's shopping basket. Saturated fat for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Measured: At completion of ~20 minute shopping task
Total sodium purchased
Total milligrams of sodium of products in a participant's shopping basket. This will be calculated by adding together the total sodium from each product in the participant's shopping basket. Sodium for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Measured: At completion of ~20 minute shopping task
Secondary outcomes (6)
Percentage of ultra-processed products purchased
The percentage of products in a participant's shopping basket that are ultra-processed, as defined by the NOVA classification system.
Measured: At completion of ~20 minute shopping task
Perceived healthfulness of unhealthy products
Perceived healthfulness of sets of dairy products, bread, and chips with FOPLs according to study condition. Likert response options are on a 1 to 5 scale, with higher scores representing a higher perceived healthfulness of the products.
Measured: ~10 minute post-test computer survey following the ~20 minute shopping task
Perceived product appeal of unhealthy products
Perceived product appeal of sets of dairy products, bread, and chips with FOPLs according to study condition. Likert response options are on a 1 to 5 scale, with higher scores representing a higher perceived product appeal of the products.
Measured: ~10 minute post-test computer survey following the ~20 minute shopping task
Health concerns of unhealthy products
Perceived concern about health effects of sets of dairy products, bread, and chips with FOPLs according to study condition. Likert response options are on a 1 to 5 scale, with higher scores representing a higher health concern of the products.
Measured: ~10 minute post-test computer survey following the ~20 minute shopping task
Correct identification of high sugar/saturated fat/sodium content of unhealthy products
Percentage of participants who correctly identified the sets of dairy products, bread, and chips as high in sugar, saturated fat, and/or sodium. Response options are yes, no, and I don't know.
Measured: ~10 minute post-test computer survey following the ~20 minute shopping task
Noticing of the label
Percentage of participants who noticed the magnifying glass FOPLs in the experimental online grocery store. Response options are yes, no, and I don't know.
Measured: ~10 minute post-test computer survey following the ~20 minute shopping task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start24 May 2023
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 3,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Sponsor
- Investigators
- Ana Clara Duran, PhD, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789238
- Sponsor's protocol ID
- 21-2129
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. 2016 Jan 26;133(4):422-33. doi: 10.1161/CIRCULATIONAHA.114.008727.
PubMed 26811272World Health Organization. Noncommunicable Diseases (NCD) Country Profiles: Brazil. Published 2018. Accessed July 28, 2021. https://www.who.int/nmh/countries/bra_en.pdf.
Wang YJ, Yeh TL, Shih MC, Tu YK, Chien KL. Dietary Sodium Intake and Risk of Cardiovascular Disease: A Systematic Review and Dose-Response Meta-Analysis. Nutrients. 2020 Sep 25;12(10):2934. doi: 10.3390/nu12102934.
PubMed 32992705Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563.
PubMed 24493081Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
PubMed 32428300Agência Nacional de Vigilância Sanitária. Apresentação rotulagem nutricional_19a. Published 2020. Accessed July 28, 2021. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/aprovada-norma-sobre-rotulagem-nutricional/apresentacao-rotulagem-nutricional_19a.pdf/view
Cancer Council Australia. Nutrient warning labels. Obesity Evidence Hub website. Published September 9, 2020. Accessed July 28, 2021. https://www.obesityevidencehub.org.au/collections/prevention/nutrient-warning-labels.
Correa T, Fierro C, Reyes M, Dillman Carpentier FR, Taillie LS, Corvalan C. "Responses to the Chilean law of food labeling and advertising: exploring knowledge, perceptions and behaviors of mothers of young children". Int J Behav Nutr Phys Act. 2019 Feb 13;16(1):21. doi: 10.1186/s12966-019-0781-x.
PubMed 30760273
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Online Store for Testing Regulatory Food and Nutrition Policies in Brazil
- ClinicalTrials.gov ID
- NCT05789238
- Acronym / sponsor ID
- 21-2129
- Conditions
- Dietary Habits
- Keywords
- front-of-package labels, ANVISA, PAHO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,026 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- 24 May 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 29 Mar 2023 (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 purpose of this randomized controlled trial is to assess the impact of different nutrient profiles for magnifying glass front-of-package labels (FOPLs) on consumer choices in an online grocery store. Participants will be adults residing in Brazil recruited through a survey research firm. Participants will be randomly assigned to one of three shopping environments in an online grocery store. Participants will complete a shopping task (selecting items from a pre-specified shopping list) in the online grocery store. After completing the shopping task, participants will be rerouted to a computer survey. The survey will include standard behavior and label perception questions, as well as demographic items.
Detailed description
Among noncommunicable disease, cardiovascular-related diseases are the leading cause of death worldwide and contribute to almost one-third of deaths in Brazil. Cardiovascular disease has become the leading cause of death in Brazil since 1960 due in part to poor eating habits, obesity, and insufficient physical activity. Consumption of high levels of sodium, added sugar, and saturated fat is a major driver of the development of cardiovascular disease. In this context, nutrition policies and interventions, such as the use of warning labels, are an important tool for reducing risk of diet-related diseases. The Brazilian Ministry of Health has recently announced efforts to combat the country's growing burden of diet-related noncommunicable diseases, and Brazil's National Health Surveillance Agency (ANVISA) has approved a more transparent and accessible system for communicating nutrition information for foods and beverages. The proposal will require labeling with a magnifying glass symbol on the front of products' packages to inform consumers about excess nutrients (i.e., sodium, sugar, saturated fat). Similar interventions have been implemented across Latin America, including Chile, Peru, and Mexico. A recent study in Chile demonstrated a reduction in purchases of food and drink items displaying warning labels.
This study seeks to test the effectiveness of different nutrient profiles to determine which products should carry the new labels in Brazil (i.e., the Pan-American Health Organization's profile or Brazil's National Health Surveillance Agency's proposed profile). Additionally, it seeks to assess whether the inclusion of information about products' ultra-processed nature further impacts consumers' product perceptions. The study will provide critical information for the Brazilian Ministry of Health on the effectiveness of the new label proposal and on strategies to inform Brazilians of product healthfulness.
Participants will be initially redirected from Cint (an online panel company). Following online consent and completion of a screening survey, participants will be redirected to an experimental online grocery store (Saruê), given a shopping list, and asked to shop for the items on the list as if in a real store. Upon redirection from Cint, participants will be randomly assigned into three arms: 1) control (no FOPLs); 2) FOPLs applied to products based on Brazil's National Health Surveillance Agency (ANVISA)'s nutrient profile model; or 3) front-of-package labels applied to products based on the Pan-American Health Organization (PAHO)'s nutrient profile model. After participants select products and check out, they will answer a survey about their perceptions about the labels and products carrying them. These questions will include self-reported responses to the content (e.g., elaboration, beliefs). After data collection, data on participants' selected products in the online grocery store will be analyzed to determine which nutrient profile was the most effective in decreasing participants' consumption of key nutrients.
Setting: The trial will take place in Saruê, an experimental online grocery store created for researchers to examine how front-of-package labels influence consumer purchases in a controlled but realistic environment. The online store reflects real-world prices and is modeled after Pão de Açúcar, a Brazilian online grocery store .
Recruitment: Participants will be recruited through Cint, a survey research firm. The eligibility criteria are residing in Brazil, being 18 years or older, and being responsible for at least half of the grocery shopping for one's household. Participants are ineligible if they were involved in any pre-testing related to the survey. Experiments conducted using online convenience samples, such as those recruited by Cint, largely replicate findings from studies conducted via probability-based samples. Cint will screen for eligibility and recruit participants from their pool of 8 million participants in Brazil. Approximately 3,000 participants will be recruited. As compensation, participants will receive incentives or points that can be redeemed for gift cards or goods per Cint's protocols.
Informed Consent: Participants will sign an informed consent form that follows a structure that is customary in Brazil.
Randomization: After the participant has signed the consent form, they will be randomly assigned to one of the three study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to each trial arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No labels for products high in added sugar, saturated fat, or sodium |
| ANVISA | Experimental | Behavioral: ANVISALevels of added sugars, saturated fat, and sodium, if exceeded according to the Brazil Nutrient Profile Model, will require the magnifying glass FOPL below on the front of the package for either solid food or liquid food. |
| PAHO | Experimental | Behavioral: PAHOPAHO Model is not based on thresholds (cut-off limits), but by percentage of regulated nutrient values in total calories amount and by NOVA categories. Therefore, the Brazil team has classified products from the dataset into NOVA categories and created calculations to apply the PAHO model to PdeA products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Resides in Brazil
- Does at least half of the grocery shopping for their household
Key exclusion criteria (1 listed)
- Involved in any pre-testing
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 |
|---|---|---|
| ANVISAProducts carrying front-of-package labels based on Brazil's Health Regulatory Agency (ANVISA's) nutrient profile model | Behavioural | ANVISA |
| PAHOProducts carrying front-of-package labels based on the Pan-American Health Organization (PAHO's) nutrient profile model | Behavioural | PAHO |
Primary outcome
Total sugar purchased
Time frame: At completion of ~20 minute shopping task
Total grams of sugar of products in a participant's shopping basket. This will be calculated by adding together the total sugar from each product in the participant's shopping basket. Sugar for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Total saturated fat purchased
Time frame: At completion of ~20 minute shopping task
Total grams of saturated fat of products in a participant's shopping basket. This will be calculated by adding together the total saturated fat from each product in the participant's shopping basket. Saturated fat for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Total sodium purchased
Time frame: At completion of ~20 minute shopping task
Total milligrams of sodium of products in a participant's shopping basket. This will be calculated by adding together the total sodium from each product in the participant's shopping basket. Sodium for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
6 secondary outcomes
Percentage of ultra-processed products purchased
Time frame: At completion of ~20 minute shopping task
Perceived healthfulness of unhealthy products
Time frame: ~10 minute post-test computer survey following the ~20 minute shopping task
Perceived product appeal of unhealthy products
Time frame: ~10 minute post-test computer survey following the ~20 minute shopping task
Health concerns of unhealthy products
Time frame: ~10 minute post-test computer survey following the ~20 minute shopping task
Correct identification of high sugar/saturated fat/sodium content of unhealthy products
Time frame: ~10 minute post-test computer survey following the ~20 minute shopping task
Noticing of the label
Time frame: ~10 minute post-test computer survey following the ~20 minute shopping task
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 3 Jul 2023.
- Background: PubMed 26811272Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. 2016 Jan 26;133(4):422-33. doi: 10.1161/CIRCULATIONAHA.114.008727.
- BackgroundWorld Health Organization. Noncommunicable Diseases (NCD) Country Profiles: Brazil. Published 2018. Accessed July 28, 2021. https://www.who.int/nmh/countries/bra_en.pdf.
- Background: PubMed 32992705Wang YJ, Yeh TL, Shih MC, Tu YK, Chien KL. Dietary Sodium Intake and Risk of Cardiovascular Disease: A Systematic Review and Dose-Response Meta-Analysis. Nutrients. 2020 Sep 25;12(10):2934. doi: 10.3390/nu12102934.
- Background: PubMed 24493081Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563.
- Background: PubMed 32428300Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
- BackgroundAgência Nacional de Vigilância Sanitária. Apresentação rotulagem nutricional_19a. Published 2020. Accessed July 28, 2021. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/aprovada-norma-sobre-rotulagem-nutricional/apresentacao-rotulagem-nutricional_19a.pdf/view
- BackgroundCancer Council Australia. Nutrient warning labels. Obesity Evidence Hub website. Published September 9, 2020. Accessed July 28, 2021. https://www.obesityevidencehub.org.au/collections/prevention/nutrient-warning-labels.
- Background: PubMed 30760273Correa T, Fierro C, Reyes M, Dillman Carpentier FR, Taillie LS, Corvalan C. "Responses to the Chilean law of food labeling and advertising: exploring knowledge, perceptions and behaviors of mothers of young children". Int J Behav Nutr Phys Act. 2019 Feb 13;16(1):21. doi: 10.1186/s12966-019-0781-x.
- Individual participant dataSharing planned: No
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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.
Ana Clara Duran, PhD principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANVISA and PAHO in people with Dietary Habits, run by University of North Carolina, Chapel Hill at 1 site in Brazil.
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 3 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 3 Jul 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 Brazil. 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?
Total sugar purchased (time frame: At completion of ~20 minute shopping task). The study lists 3 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 NCT05789238, which also lists 8 linked publications.
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 3 Jul 2023.