Food SelectionNCT06678178
Climate Impact Label Design and Fast-Food Meal Selection
A study testing Warning High Climate Impact Labels, Traffic Light Labels and Climate Grade Labels in people with Food Selection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The primary objective of this study is to test the relative effects of climate-impact menu label designs on the healthfulness of consumers' fast-food meal choices. Participants will complete a hypothetical online meal ordering task using a survey which emulates the online menu of a burger restaurant chain. 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?
- Warning High Climate Impact Labels, Traffic Light Labels and Climate Grade Labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,622 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 of age or older
- Member of the CloudResearch panel
- Residing in the United States
Who cannot join
- Under 18 years of age
- Not residing in the United States
- Completed the survey implausibly quick based on the distribution of the time to complete the survey among all participants
- Failed the built-in Qualtrics survey fraud detection measures
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Testing Climate Impact Menu Labels Influence on Nutrition Quality of Fast-Food Selections: A Pilot Study
The primary objective of this study is to test the relative effects of climate-impact menu label designs on the healthfulness of consumers' fast-food meal choices. Participants will complete a hypothetical online meal ordering task using a survey which emulates the online menu of a burger restaurant chain. Participants will be randomized for exposure to menus featuring one of five labeling conditions. Secondary objectives include examining total greenhouse gas emissions per meal order and, through a post-order survey, perception of labels between the conditions.
Read the detailed description
This online randomized trial will test the relative effects of climate impact menu label designs on the healthfulness of consumers' fast-food meal choices and perceptions of menu items. The survey research firm CloudResearch will recruit a sample of 6,250 adults aged 18 years and older who speak English and reside in the United States.
Participants will complete a between-subjects online experiment in which the participants will be randomized to view a fast-food online ordering menu with one of five labeling schemes applied: (1) a QR code on all items (control); (2) a high climate impact warning label on high impact items; (3) traffic light labels on all items by level of impact; (4) climate grade labels on all items by level of impact; and (5) numeric carbon footprint labels on all items. All fast-food menus will include main items, sides, desserts, and drinks. Labels will only appear alongside main menu items and will be assigned using thresholds for greenhouse gas emissions set a priori in kilograms of carbon dioxide (CO2) equivalent per kilogram of food. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. After completing the meal ordering task, participants will be prompted to answer questions about the perception of the labeling condition which the participants were randomized to view, perception of the relative effectiveness of all labels in this experiment, and personal values, dietary patterns, and other demographic information.
The primary outcome will be the healthfulness of meal orders selected from the online menu, indicated by a modified Nutrient Profile Index meal score for all food items ordered. Secondary outcomes will be total greenhouse gas emissions per meal ordered, total calories ordered, whether a sugar-sweetened beverage was ordered, and perceived message effectiveness of the climate-impact labels.
- Conditions
- Food Selection
- Being tested
- Control (QR) Labels, Warning High Climate Impact Labels, Traffic Light Labels, Climate Grade Labels, Numeric Carbon Footprint Labels
- Keywords
- food labeling, climate labeling, choice behavior
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (QR) LabelsBehavioural
Participants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Control (QR) labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order.
Warning High Climate Impact LabelsBehavioural
Participants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Warning High Climate Impact labels will be displayed beneath select items. Participants will be instructed to select up to 4 menu items for a hypothetical meal order.
Traffic Light LabelsBehavioural
Participants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Traffic Light labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order.
Climate Grade LabelsBehavioural
Participants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Climate Grade labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order.
Numeric Carbon Footprint LabelsBehavioural
Participants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Numeric Carbon Footprint labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order.
| Study group | Role | What they receive |
|---|---|---|
| Control (QR) Labels | Placebo comparator | A black label featuring a QR code and white text that reads "SCAN HERE" will be placed beneath all main menu items. Explanatory text describing the label's meaning will be displayed at the top of the menu. Receives: Behavioral: Control (QR) Labels |
| Warning High Climate Impact Labels | Experimental | A red icon-plus-text label that reads "WARNING: HIGH CLIMATE IMPACT" in white text will be placed beneath main menu items with a high climate impact using a predetermined threshold of estimated greenhouse gas emissions set at >=9.2 kgCO2e. Labels will include a white globe icon directly preceding the label text. Explanatory text describing the label's meaning will be displayed at the top of the menu. Receives: Behavioral: Warning High Climate Impact Labels |
| Traffic Light Labels | Experimental | Traffic Light labels will be placed beneath all main menu items. Using predetermined estimated greenhouse gas emission thresholds, each item will be assigned one of three icon-plus-text labels within this scheme: low-, medium-, or high-impact label, set in kgCO2e at <2.6, >=2.6 \& <9.2, and >=9.2, respectively. Each will read, "HIGH CLIMATE IMPACT" within a red label, "MED. CLIMATE IMPACT" in a yellow label, and "LOW CLIMATE IMPACT" in a green label. Text for all labels written in white, and a white globe icon will precede the text. Explanatory text describing the meaning of the labels will be displayed at the top of the menu. Receives: Behavioral: Traffic Light Labels |
| Climate Grade Labels | Experimental | Climate Grade labels will be placed beneath all main menu items, using predetermined estimated greenhouse gas emission thresholds to assign one of five icon-plus-text labels which indicate a specific climate impact grade (A, B, C, D, and F). Thresholds are set in kgCO2e as follows: [A] <1.7, [B] >=1.7 \& <2.6, [C] >=2.6 \& <9.2, [D] >=9.2 \& <28, [F] >=28. All labels are solid black with a white globe icon followed by white text which reads "CLIMATE GRADE". On the left side of each label, a grade is displayed, capitalized and in a white font within a solid-colored box. The color of the box corresponds with each letter grade: A = dark green, B = light green, C = yellow, D = orange, F = red. Beneath the letter grade, a gradient of all possible grades is displayed horizontally in smaller font, each grade atop a small solid box in the respective grade color. Explanatory text describing the meaning of the labels will be displayed at the top of the menu. Receives: Behavioral: Climate Grade Labels |
| Numeric Carbon Footprint Labels | Experimental | Numeric Carbon Footprint labels will be placed beneath all main menu items and display the estimated greenhouse gas emissions in kilograms of carbon dioxide equivalents (kgCO2e) for each item. All labels have a solid black background and an icon-plus-text design. A white globe icon is followed by text stating the value of the items estimated emissions and the unit "kgCO2e". Explanatory text describing the meaning of the labels will be displayed at the top of the menu. Receives: Behavioral: Numeric Carbon Footprint Labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Nutrient Profile Index Score
The primary outcome measure will be the healthfulness of the fast-food meal selections, measured with a modified Nutrient Profile Index (NPI) score. NPI scores are based on the United Kingdom (UK) Ofcom Nutrient Profiling Model, which is used to score individual foods in the UK to determine which ones can be marketed to children. The NPI is a 0 to 100-point score for foods; scores >=64 are considered healthy. NPI awards points from nutrients to encourage (e.g., fiber, protein) and nutrients of concern (e.g., sodium, sugar) per 100 grams. The investigators will generate a modified NPI score to evaluate the healthfulness of full meals comprised of multiple food items. This measure will be determined by calculating the weighted mean NPI score of all food items selected per meal, with each item's NPI score weighted by its proportionate contribution of mass in grams to the total mass of the meal.
Measured: approximately 1 minute
Secondary outcomes (4)
Total Greenhouse Gas Emissions as Assessed by Cumulative Total Kilograms of Carbon Equivalent (kgCO2e) Per Kilogram
Cumulative total kilograms of carbon equivalent (kgCO2e) per kilogram of food for all meal items.
Measured: approximately 1 minute
Perceived Message Effectiveness (PME) as Assessed by the University of North Carolina (UNC) PME Scale
The 3-item University of North Carolina (UNC)-PME scale measures how much the label placed beneath high climate impact menu items, discouraged consumption or evoked concern or unpleasantness about consumption of high climate impact foods. Responses to all questions will be measured on a 5-point unipolar Likert scale from 1=Not at all to 5= A great deal. Preceding the questions, participants will view the assigned label demonstrating high climate impact and the following prompt: "Considering this label, how much do you agree or disagree with the following statements." The exact text for each question is: "This label discourages me from wanting to eat foods with a high climate impact." " This label makes eating foods with a high climate impact seem unpleasant." " This label makes me concerned about eating foods with a high climate impact." The mean likert scale choice is reported. The scale choice range is between 1 and 5, with higher scores interpreted as better.
Measured: approximately 1 minute
Total Energy (Calories) Selected
The total number of calories in participants' hypothetical meal orders, calculated as the sum of calories across all menu items selected. Higher values indicate more calories selected.
Measured: approximately 1 minute
Number of Participants Who Selected Sugar-sweetened Beverage
Measured as a dichotomous variable (yes/no) indicating whether participants' hypothetical meal orders include a sugar-sweetened beverage.
Measured: approximately 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start2 Dec 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Model description
- Participants will be randomized to view a fast-food menu with one of five labeling schemes applied: (1) a QR code on all items (control); (2) a high climate impact warning label on high impact items; (3) traffic light labeling on all items by level of impact; (4) climate grade labels on all items by level of impact; and (5) numeric labels on all items. All fast-food menus will include main items, sides, desserts, and drinks. Labels will only appear alongside main menu items and will be assigned using thresholds for greenhouse gas emissions set a priori in kilograms of CO2 equivalent per kilogram of food. Participants will be instructed to select a hypothetical lunch meal order. The investigators will record participant meal selections and, using publicly available nutritional information for each item selected, calculate a score of overall meal healthfulness.
- Masking
- None (open label)
- Enrolment
- 6,622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Davis, Harvard School of Public Health (HSPH), University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Julia Wolfson, PHD MPP, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678178
- Sponsor's protocol ID
- IRB00030419
- Other IDs
- 1R01DK139327-01, IRB00030419
- Status last verified
- Jan 2026
- First submitted
- 5 Nov 2024
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Climate Impact Menu Labels Influence on Nutrition Quality of Fast-Food Selections: A Pilot Study
- ClinicalTrials.gov ID
- NCT06678178
- Acronym / sponsor ID
- IRB00030419
- Conditions
- Food Selection
- Keywords
- food labeling, climate labeling, choice behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,622 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Davis, Harvard School of Public Health (HSPH), University of Pennsylvania
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to test the relative effects of climate-impact menu label designs on the healthfulness of consumers' fast-food meal choices. Participants will complete a hypothetical online meal ordering task using a survey which emulates the online menu of a burger restaurant chain. Participants will be randomized for exposure to menus featuring one of five labeling conditions. Secondary objectives include examining total greenhouse gas emissions per meal order and, through a post-order survey, perception of labels between the conditions.
Detailed description
This online randomized trial will test the relative effects of climate impact menu label designs on the healthfulness of consumers' fast-food meal choices and perceptions of menu items. The survey research firm CloudResearch will recruit a sample of 6,250 adults aged 18 years and older who speak English and reside in the United States.
Participants will complete a between-subjects online experiment in which the participants will be randomized to view a fast-food online ordering menu with one of five labeling schemes applied: (1) a QR code on all items (control); (2) a high climate impact warning label on high impact items; (3) traffic light labels on all items by level of impact; (4) climate grade labels on all items by level of impact; and (5) numeric carbon footprint labels on all items. All fast-food menus will include main items, sides, desserts, and drinks. Labels will only appear alongside main menu items and will be assigned using thresholds for greenhouse gas emissions set a priori in kilograms of carbon dioxide (CO2) equivalent per kilogram of food. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. After completing the meal ordering task, participants will be prompted to answer questions about the perception of the labeling condition which the participants were randomized to view, perception of the relative effectiveness of all labels in this experiment, and personal values, dietary patterns, and other demographic information.
The primary outcome will be the healthfulness of meal orders selected from the online menu, indicated by a modified Nutrient Profile Index meal score for all food items ordered. Secondary outcomes will be total greenhouse gas emissions per meal ordered, total calories ordered, whether a sugar-sweetened beverage was ordered, and perceived message effectiveness of the climate-impact labels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants will be randomized to view a fast-food menu with one of five labeling schemes applied: (1) a QR code on all items (control); (2) a high climate impact warning label on high impact items; (3) traffic light labeling on all items by level of impact; (4) climate grade labels on all items by level of impact; and (5) numeric labels on all items. All fast-food menus will include main items, sides, desserts, and drinks. Labels will only appear alongside main menu items and will be assigned using thresholds for greenhouse gas emissions set a priori in kilograms of CO2 equivalent per kilogram of food. Participants will be instructed to select a hypothetical lunch meal order. The investigators will record participant meal selections and, using publicly available nutritional information for each item selected, calculate a score of overall meal healthfulness.
| Arm | Type | Receives |
|---|---|---|
| Control (QR) Labels | Placebo comparator | Behavioral: Control (QR) LabelsA black label featuring a QR code and white text that reads "SCAN HERE" will be placed beneath all main menu items. Explanatory text describing the label's meaning will be displayed at the top of the menu. |
| Warning High Climate Impact Labels | Experimental | Behavioral: Warning High Climate Impact LabelsA red icon-plus-text label that reads "WARNING: HIGH CLIMATE IMPACT" in white text will be placed beneath main menu items with a high climate impact using a predetermined threshold of estimated greenhouse gas emissions set at >=9.2 kgCO2e. Labels will include a white globe icon directly preceding the label text. Explanatory text describing the label's meaning will be displayed at the top of the menu. |
| Traffic Light Labels | Experimental | Behavioral: Traffic Light LabelsTraffic Light labels will be placed beneath all main menu items. Using predetermined estimated greenhouse gas emission thresholds, each item will be assigned one of three icon-plus-text labels within this scheme: low-, medium-, or high-impact label, set in kgCO2e at <2.6, >=2.6 \& <9.2, and >=9.2, respectively. Each will read, "HIGH CLIMATE IMPACT" within a red label, "MED. CLIMATE IMPACT" in a yellow label, and "LOW CLIMATE IMPACT" in a green label. Text for all labels written in white, and a white globe icon will precede the text. Explanatory text describing the meaning of the labels will be displayed at the top of the menu. |
| Climate Grade Labels | Experimental | Behavioral: Climate Grade LabelsClimate Grade labels will be placed beneath all main menu items, using predetermined estimated greenhouse gas emission thresholds to assign one of five icon-plus-text labels which indicate a specific climate impact grade (A, B, C, D, and F). Thresholds are set in kgCO2e as follows: [A] <1.7, [B] >=1.7 \& <2.6, [C] >=2.6 \& <9.2, [D] >=9.2 \& <28, [F] >=28. All labels are solid black with a white globe icon followed by white text which reads "CLIMATE GRADE". On the left side of each label, a grade is displayed, capitalized and in a white font within a solid-colored box. The color of the box corresponds with each letter grade: A = dark green, B = light green, C = yellow, D = orange, F = red. Beneath the letter grade, a gradient of all possible grades is displayed horizontally in smaller font, each grade atop a small solid box in the respective grade color. Explanatory text describing the meaning of the labels will be displayed at the top of the menu. |
| Numeric Carbon Footprint Labels | Experimental | Behavioral: Numeric Carbon Footprint LabelsNumeric Carbon Footprint labels will be placed beneath all main menu items and display the estimated greenhouse gas emissions in kilograms of carbon dioxide equivalents (kgCO2e) for each item. All labels have a solid black background and an icon-plus-text design. A white globe icon is followed by text stating the value of the items estimated emissions and the unit "kgCO2e". Explanatory text describing the meaning of the labels will be displayed at the top of the menu. |
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 of age or older
- Member of the CloudResearch panel
- Residing in the United States
Key exclusion criteria (4 listed)
- Under 18 years of age
- Not residing in the United States
- Completed the survey implausibly quick based on the distribution of the time to complete the survey among all participants
- Failed the built-in Qualtrics survey fraud detection measures
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 |
|---|---|---|
| Control (QR) LabelsParticipants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Control (QR) labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. | Behavioural | Control (QR) Labels |
| Warning High Climate Impact LabelsParticipants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Warning High Climate Impact labels will be displayed beneath select items. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. | Behavioural | Warning High Climate Impact Labels |
| Traffic Light LabelsParticipants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Traffic Light labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. | Behavioural | Traffic Light Labels |
| Climate Grade LabelsParticipants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Climate Grade labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. | Behavioural | Climate Grade Labels |
| Numeric Carbon Footprint LabelsParticipants will view a fast-food restaurant menu including main, side, dessert, and drink items. Each menu item will be displayed with an image of the item, name, price, and total calories. For main items only, Numeric Carbon Footprint labels will be displayed beneath each item. Participants will be instructed to select up to 4 menu items for a hypothetical meal order. | Behavioural | Numeric Carbon Footprint Labels |
Primary outcome
Modified Nutrient Profile Index Score
Time frame: approximately 1 minute
The primary outcome measure will be the healthfulness of the fast-food meal selections, measured with a modified Nutrient Profile Index (NPI) score. NPI scores are based on the United Kingdom (UK) Ofcom Nutrient Profiling Model, which is used to score individual foods in the UK to determine which ones can be marketed to children. The NPI is a 0 to 100-point score for foods; scores >=64 are considered healthy. NPI awards points from nutrients to encourage (e.g., fiber, protein) and nutrients of concern (e.g., sodium, sugar) per 100 grams. The investigators will generate a modified NPI score to evaluate the healthfulness of full meals comprised of multiple food items. This measure will be determined by calculating the weighted mean NPI score of all food items selected per meal, with each item's NPI score weighted by its proportionate contribution of mass in grams to the total mass of the meal.
4 secondary outcomes
Total Greenhouse Gas Emissions as Assessed by Cumulative Total Kilograms of Carbon Equivalent (kgCO2e) Per Kilogram
Time frame: approximately 1 minute
Perceived Message Effectiveness (PME) as Assessed by the University of North Carolina (UNC) PME Scale
Time frame: approximately 1 minute
Total Energy (Calories) Selected
Time frame: approximately 1 minute
Number of Participants Who Selected Sugar-sweetened Beverage
Time frame: approximately 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julia Wolfson, PHD MPP principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warning High Climate Impact Labels, Traffic Light Labels and Climate Grade Labels in people with Food Selection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 4 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 6 Jan 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Nutrient Profile Index Score (time frame: approximately 1 minute). 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 6 Jan 2026.