Food SelectionSUPERNETNCT02769455
Online Experimental Supermarket
A study testing Reference intakes and 5-CNL in people with Food Selection, run by University of Paris 13 at 1 site in France.
Trial summary
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Reference intakes and 5-CNL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Jul 2017
- 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
- Subjects 30-50 years old
- Having finished their studies and currently active (either working or unemployed)
- Income/UC <1200€/month
- Subject 18-25 years old
- Self-declared as student
- Subjects >50 years-old
- Diagnosed with one or more of the following chronic conditions (self-reported) : type 2 diabetes, dislipidemia (elevated cholesterol levels, low HDL cholesterol levels, elevated triglycerides levels), hypertension, cardiovascular disease, obesity
Who cannot join
- Student, retired
- Subjects living outside of mainland France
- Subjects never engaging in grocery shopping
- TRIAL N°2
- Subjects never engaging in grocery shopping
- TRIAL N°3
- Subjects declaring suffering from none of the mentioned chronic conditions
- Subjects never engaging in grocery shopping
Trial locations and contacts
1 site in 1 country.
France1 site
Equipe de Recherche en Epidémiologie Nutritionnelle
Bobigny, 93017
About this study
Official title: Impact of front-of Pack Nutrition Labels on Purchase Intentions in an Online Supermarket-A Series of Randomized Trials
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets.
The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL).
Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.
Read the detailed description
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. Modelling studies suggested that adoption of effective nutrition labelling would be cost-effective and provide health benefits. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. Moreover, a recent randomized trial, based on an online experimental supermarket, showed that the 5-CNL displayed the highest difference in nutritional quality compared to the control situation. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets. Subjects with lower levels of income, or the young appear as a key target in which the impact of FOP nutrition labels has been poorly explored. Moreover, the impact of such a label on subjects suffering from a chronic condition for which dietary modifications are part of the treatment should be carefully considered, in order to avoid potential undesirable effects of the label in these populations.
The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL).
Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.
- Conditions
- Food Selection
- Being tested
- Reference intakes, 5-CNL
- Keywords
- Food Labelling
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference intakesOther
FOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium.
The presentation of the products will always include the label affixed on it. Moreover, the product pages will include two pictures of the product: one with only the package (including the RI as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant. These elements ensure higher visibility, awareness and understanding of the label.
5-CNLOther
The 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews.
The format includes five categories, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the one corresponding to the product being enlarged.
The presentation of the products will always include the label affixed on it. Two pictures of the product will be included: one with only the package (including the 5-CNL as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will not be exposed to any FOP nutrition labels |
| Front-of-pack labelling (Reference Intakes) | Experimental | The second group will be exposed to a FOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are presented in the form of a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium. Receives: Other: Reference intakes |
| Front-of-pack labelling (5-CNL) | Experimental | The 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews.
The format of the 5-CNL system therefore includes five categories of nutritional quality of food products, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the letter/colour corresponding to the product being enlarged. Receives: Other: 5-CNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSA Score
Mean nutritional quality of the items in the shopping cart, using the mean Food Standards Agency nutrient profiling system (FSA score) of the items in the shopping cart. The FSA score for foods and beverages is computed taking into account nutrient content for 100g. It allocates positive points (0-10) for content in energy (KJ), total sugar (g), saturated fatty acids (g) and sodium (mg). Negative points (0-5) are allocated to content in fruits, vegetables, legumes and nuts (%), fibers (g) and proteins (g). Scores for foods and beverages were therefore based on a discrete continuous scale from -15 (most healthy) to +40 (less healthy). Modifications to the original score were used in order to ensure a higher consistency with French nutritional recommendations for beverages, cheese and added fats
Measured: 3 months
Secondary outcomes (7)
Calories (/100g)
Mean calorie density of the items in the shopping cart. Calorie content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Saturates (g/100g)
Mean saturated fat content of the items in the shopping cart. Saturates content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Sugar (g/100g)
Mean sugar content of the items in the shopping cart. Sugar content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Sodium (mg/100g)
Mean sodium content of the items in the shopping cart. Sodium content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Fibers (g/100g)
Mean fiber content of the items in the shopping cart. Fiber content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Proteins (g/100g)
Mean protein content of the items in the shopping cart. Protein content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Fruits and vegetables (%/100g)
Mean fruit and vegetables content of the items in the shopping cart. Fruits and vegetables content per 100g for each item is taken into account. No weighing on total energy or weight of the shopping cart.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food SelectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 13
- Sponsor type
- University, hospital or other
- Collaborators
- Intitut National du Cancer
- Responsible party
- Principal investigator, Serge HERCBERG, University of Paris 13
- Investigators
- Serge Hercberg, Principal investigator, Nutritional Epidemiology Research Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769455
- Sponsor's protocol ID
- SM2
- Acronym
- SUPERNET
- Status last verified
- Sep 2017
- First submitted
- 9 May 2016
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Fezeu L, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of individuals with chronic diseases: results of a randomised trial. BMJ Open. 2022 Aug 29;12(8):e058139. doi: 10.1136/bmjopen-2021-058139.
PubMed 36038180Egnell M, Galan P, Fialon M, Touvier M, Peneau S, Kesse-Guyot E, Hercberg S, Julia C. The impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of unprocessed and processed foods: post-hoc analyses from three randomized controlled trials. Int J Behav Nutr Phys Act. 2021 Mar 17;18(1):38. doi: 10.1186/s12966-021-01108-9.
PubMed 33731145Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Buscail C, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Randomised controlled trial in an experimental online supermarket testing the effects of front-of-pack nutrition labelling on food purchasing intentions in a low-income population. BMJ Open. 2021 Feb 8;11(2):e041196. doi: 10.1136/bmjopen-2020-041196.
PubMed 33558350
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of front-of Pack Nutrition Labels on Purchase Intentions in an Online Supermarket-A Series of Randomized Trials
- ClinicalTrials.gov ID
- NCT02769455
- Acronym / sponsor ID
- SUPERNET / SM2
- Conditions
- Food Selection
- Keywords
- Food Labelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of Paris 13University, hospital or other
- Collaborators
- Intitut National du Cancer
- Study start
- Aug 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets.
The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL).
Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.
Detailed description
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. Modelling studies suggested that adoption of effective nutrition labelling would be cost-effective and provide health benefits. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. Moreover, a recent randomized trial, based on an online experimental supermarket, showed that the 5-CNL displayed the highest difference in nutritional quality compared to the control situation. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets. Subjects with lower levels of income, or the young appear as a key target in which the impact of FOP nutrition labels has been poorly explored. Moreover, the impact of such a label on subjects suffering from a chronic condition for which dietary modifications are part of the treatment should be carefully considered, in order to avoid potential undesirable effects of the label in these populations.
The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL).
Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will not be exposed to any FOP nutrition labels |
| Front-of-pack labelling (Reference Intakes) | Experimental | Other: Reference intakesThe second group will be exposed to a FOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are presented in the form of a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium. |
| Front-of-pack labelling (5-CNL) | Experimental | Other: 5-CNLThe 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews. The format of the 5-CNL system therefore includes five categories of nutritional quality of food products, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the letter/colour corresponding to the product being enlarged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects 30-50 years old
- Having finished their studies and currently active (either working or unemployed)
- Income/UC <1200€/month
- Subject 18-25 years old
- Self-declared as student
Key exclusion criteria (8 listed)
- Student, retired
- Subjects living outside of mainland France
- Subjects never engaging in grocery shopping
- TRIAL N°2
- Subjects never engaging in grocery shopping
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 |
|---|---|---|
| Reference intakesFOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium. The presentation of the products will always include the label affixed on it. Moreover, the product pages will include two pictures of the product: one with only the package (including the RI as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant. These elements ensure higher visibility, awareness and understanding of the label. | Other | Front-of-pack labelling (Reference Intakes) |
| 5-CNLThe 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews. The format includes five categories, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the one corresponding to the product being enlarged. The presentation of the products will always include the label affixed on it. Two pictures of the product will be included: one with only the package (including the 5-CNL as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant. | Other | Front-of-pack labelling (5-CNL) |
Primary outcome
FSA Score
Time frame: 3 months
Mean nutritional quality of the items in the shopping cart, using the mean Food Standards Agency nutrient profiling system (FSA score) of the items in the shopping cart. The FSA score for foods and beverages is computed taking into account nutrient content for 100g. It allocates positive points (0-10) for content in energy (KJ), total sugar (g), saturated fatty acids (g) and sodium (mg). Negative points (0-5) are allocated to content in fruits, vegetables, legumes and nuts (%), fibers (g) and proteins (g). Scores for foods and beverages were therefore based on a discrete continuous scale from -15 (most healthy) to +40 (less healthy). Modifications to the original score were used in order to ensure a higher consistency with French nutritional recommendations for beverages, cheese and added fats
7 secondary outcomes
Calories (/100g)
Time frame: 3 months
Saturates (g/100g)
Time frame: 3 months
Sugar (g/100g)
Time frame: 3 months
Sodium (mg/100g)
Time frame: 3 months
Fibers (g/100g)
Time frame: 3 months
Proteins (g/100g)
Time frame: 3 months
Fruits and vegetables (%/100g)
Time frame: 3 months
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 Oct 2017.
- Derived from this study: PubMed 36038180Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Fezeu L, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of individuals with chronic diseases: results of a randomised trial. BMJ Open. 2022 Aug 29;12(8):e058139. doi: 10.1136/bmjopen-2021-058139.
- Derived from this study: PubMed 33731145Egnell M, Galan P, Fialon M, Touvier M, Peneau S, Kesse-Guyot E, Hercberg S, Julia C. The impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of unprocessed and processed foods: post-hoc analyses from three randomized controlled trials. Int J Behav Nutr Phys Act. 2021 Mar 17;18(1):38. doi: 10.1186/s12966-021-01108-9.
- Derived from this study: PubMed 33558350Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Buscail C, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Randomised controlled trial in an experimental online supermarket testing the effects of front-of-pack nutrition labelling on food purchasing intentions in a low-income population. BMJ Open. 2021 Feb 8;11(2):e041196. doi: 10.1136/bmjopen-2020-041196.
- 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.
Serge Hercberg principal investigator
Nutritional Epidemiology Research Team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference intakes and 5-CNL in people with Food Selection, run by University of Paris 13 at 1 site in France.
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 7 inclusion and 8 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 Oct 2017. 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 France. 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?
FSA Score (time frame: 3 months). 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 NCT02769455, which also lists 3 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 Oct 2017.