ObesityNCT03490734
Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
A study testing Black Cherry and Orange Flavored Beverage with added sugar, Strawberry Kiwi &Lemonade Flavored Beverage with added sugar and Black Cherry and Orange Flavored Beverage no added sugar in people with Obesity and Weight Gain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB). Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain
- What is being tested?
- Black Cherry and Orange Flavored Beverage with added sugar, Strawberry Kiwi &Lemonade Flavored Beverage with added sugar and Black Cherry and Orange Flavored Beverage no added sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 18 Mar 2022
- 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 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Potential participants will be eligible for the study if they have BMI scores between the 18 and 34 at baseline.
Who cannot join
- Individuals with probable current Axis I psychopathology or any fMRI contra-indicators (e.g., metal implants, braces) will be excluded. Those with a probable Axis I diagnosis will be provided with treatment referral information and encouraged to seek treatment,
- current regular use (3 or more times a week) of psychoactive drugs (e.g., cocaine, marijuana, nicotine),
- regular smoking,
- serious medical problems (e.g., cancer, diabetes),
- dietary practices that do not allow intake of intervention beverages.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mcgavran-Greenberg Hall
Chapel Hill, North Carolina, 27516
About this study
The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB).
Read the detailed description
The proposed project addresses critical gaps in the understanding of the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB). Half of Americans consume SSBs on any given day.
Regular SSB intake is considered a contributing factor to excess energy intake, weight gain, and obesity, which impacts 70% of Americans. A contributing factor to repeated SSB consumption is sugar intake causes the release of dopamine (DA) and opioids in the striatum, providing positive reinforcement. As such, multiple brain-based models of food reward-driven obesity have been proposed, largely focusing on the striatum and executive functioning. These brain-based models of obesity have elucidated risk factors for overconsumption of high-sugar foods; however, data supporting these competing models rely heavily on observational studies in small samples.
Importantly, previous reports from the investigators lab and others directly implicate eating behavior patterns as a vital contributor to aberrant neurobehavioral responses to food stimuli. However, without experimental evidence, there are fundamental gaps in the investigators knowledge about the neurobehavioral adaptations that occur as an individual begins to regularly consume a SSB prior to weight change.
As observational data suggest, it is also crucial to examine individual difference factors that may exacerbate or protect against adaptations associated with regular SSB intake, as well as whether these adaptions are specific.
- Conditions
- Obesity, Weight Gain
- Being tested
- Black Cherry and Orange Flavored Beverage with added sugar, Strawberry Kiwi &Lemonade Flavored Beverage with added sugar, Black Cherry and Orange Flavored Beverage no added sugar, Strawberry Kiwi & Lemonade Flavored Beverage no added sugar, Water
- Keywords
- nutrition, obesity, weight gain, sugar, sugar sweetened beverage, dopamine, neurobehavioral adaptation
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Cherry and Orange Flavored Beverage with added sugarDietary supplement
Also called Kool-Aid®
10 oz daily for three weeks
Strawberry Kiwi &Lemonade Flavored Beverage with added sugarDietary supplement
Also called Kool-Aid®
10 oz daily for three weeks
Black Cherry and Orange Flavored Beverage no added sugarDietary supplement
Also called Kool-Aid®
10 oz daily for three weeks
Strawberry Kiwi & Lemonade Flavored Beverage no added sugarDietary supplement
Also called Kool-Aid®
10 oz daily for three weeks
WaterOther
Three mL administered per associated logo presentation only during MRI procedure.
| Study group | Role | What they receive |
|---|---|---|
| Beverage A (Sweetened) | Active comparator | One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Receives: Dietary Supplement: Black Cherry and Orange Flavored Beverage with added sugar; Other: Water |
| Beverage B (Sweetened) | Active comparator | One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Receives: Dietary Supplement: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar; Other: Water |
| Beverage A (Unsweetened) | Active comparator | One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Receives: Dietary Supplement: Black Cherry and Orange Flavored Beverage no added sugar; Other: Water |
| Beverage B (Unsweetened) | Active comparator | One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Receives: Dietary Supplement: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo
The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- > pre-intervention BOLD response to sweetened beverage logo > water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo > water logo for each arm.
Measured: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
Secondary outcomes (3)
Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)
The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages, (sweetened and unsweetened) and a water solution, and logo-elicited anticipation of both beverages and water solution. Whole-brain analyses are performed. Contrasts of interest for the within-subject models are post-intervention > pre-intervention BOLD response to beverage vs. water logo and contrasts of interest for the group model are sweetened beverage logo > water logo. To test the interaction of brain activation with BMI, BMI is entered as a covariate in the group model. Parameter estimates of significant BOLD response to these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in BOLD response in the putamen for the sweetened beverage logo > water logo for each arm.
Measured: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
Beverage Perceptual Ratings Using Visual Analog Scales
Perceptual ratings of the assigned beverage using visual analog scales are assessed at the pre- and post-intervention behavioral visits.
Visual analog scales (VAS) are presented on an iPad screen. The scale assesses response to taste after the participant consumes a small amount of the beverage. Perceived pleasantness of, and desire to consume the two beverages is measured using adapted labeled hedonic scales at pre-/post-intervention. Pleasantness is phrased 'How pleasant is this taste' and anchored by (-100) 'most unpleasant imaginable' to (100) 'most pleasant imaginable', and 'neutral' (0) in the middle. Desire follows a similar pattern using 'desire to consume' as the phrasing. Pleasantness and desire of the assigned beverage is also evaluated at the 9 intervention assessments. Higher scores represent higher pleasantness and desire.
Measured: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment
Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task
Stop-signal reaction time to assigned beverage logo are assessed at the pre- and post-intervention visits.
The behavioral response inhibition task (stop-signal task) examines motor disinhibition in response to beverage logos. This allows for the assessment of bias toward the logos and is sensitive to detect changes due to the intervention. The task is performed on an iPad app where participants complete the task twice, once at the pre-intervention and once at the post-intervention behavioral visit. The task contains 6 runs, where 3 runs present the logo of the assigned beverage and the other 3 present the logo of the same-flavor unassigned beverage. Within each run of this task, 64 (20 "go") trials are presented, and participants are instructed to make a speeded response to a "go" stimulus except for trials when a "stop" signal occurs (an X presented over the logo), in which case participants are instructed to withhold their response.
Measured: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start10 Apr 2018
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified randomization techniques will be used to distribute: 1) male \& females, 2) those with a BMI \> 26.1 \& those with a BMI \< 26.1, and 3) regular SSB consumers (\> 1/day; 12 fl oz) \& low or non-SSB consumers equally across the 2 experimental conditions (SSB vs. unsweetened beverage) and then to the two flavors within each experimental condition. BMI of 26.0 was selected as it is the midpoint of inclusion criteria 18 \< BMI \< 34.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Burger, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490734
- Sponsor's protocol ID
- 17-0710
- Other IDs
- 1R01DK112317-01A1
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2018
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peirce JW. PsychoPy--Psychophysics software in Python. J Neurosci Methods. 2007 May 15;162(1-2):8-13. doi: 10.1016/j.jneumeth.2006.11.017. Epub 2007 Jan 23.
PubMed 17254636
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
- ClinicalTrials.gov ID
- NCT03490734
- Acronym / sponsor ID
- 17-0710
- Conditions
- Obesity, Weight Gain
- Keywords
- nutrition, obesity, weight gain, sugar, sugar sweetened beverage, dopamine, neurobehavioral adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Posted 6 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB).
Detailed description
The proposed project addresses critical gaps in the understanding of the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB). Half of Americans consume SSBs on any given day.
Regular SSB intake is considered a contributing factor to excess energy intake, weight gain, and obesity, which impacts 70% of Americans. A contributing factor to repeated SSB consumption is sugar intake causes the release of dopamine (DA) and opioids in the striatum, providing positive reinforcement. As such, multiple brain-based models of food reward-driven obesity have been proposed, largely focusing on the striatum and executive functioning. These brain-based models of obesity have elucidated risk factors for overconsumption of high-sugar foods; however, data supporting these competing models rely heavily on observational studies in small samples.
Importantly, previous reports from the investigators lab and others directly implicate eating behavior patterns as a vital contributor to aberrant neurobehavioral responses to food stimuli. However, without experimental evidence, there are fundamental gaps in the investigators knowledge about the neurobehavioral adaptations that occur as an individual begins to regularly consume a SSB prior to weight change.
As observational data suggest, it is also crucial to examine individual difference factors that may exacerbate or protect against adaptations associated with regular SSB intake, as well as whether these adaptions are specific.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Stratified randomization techniques will be used to distribute: 1) male \& females, 2) those with a BMI > 26.1 \& those with a BMI < 26.1, and 3) regular SSB consumers (> 1/day; 12 fl oz) \& low or non-SSB consumers equally across the 2 experimental conditions (SSB vs. unsweetened beverage) and then to the two flavors within each experimental condition. BMI of 26.0 was selected as it is the midpoint of inclusion criteria 18 < BMI < 34.
| Arm | Type | Receives |
|---|---|---|
| Beverage A (Sweetened) | Active comparator | Dietary Supplement: Black Cherry and Orange Flavored Beverage with added sugar, Other: WaterOne quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. |
| Beverage B (Sweetened) | Active comparator | Dietary Supplement: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar, Other: WaterOne quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. |
| Beverage A (Unsweetened) | Active comparator | Dietary Supplement: Black Cherry and Orange Flavored Beverage no added sugar, Other: WaterOne quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. |
| Beverage B (Unsweetened) | Active comparator | Dietary Supplement: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar, Other: WaterOne quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Potential participants will be eligible for the study if they have BMI scores between the 18 and 34 at baseline.
Key exclusion criteria (5 listed)
- Individuals with probable current Axis I psychopathology or any fMRI contra-indicators (e.g., metal implants, braces) will be excluded. Those with a probable Axis I diagnosis will be provided with treatment referral information and encouraged to seek treatment,
- current regular use (3 or more times a week) of psychoactive drugs (e.g., cocaine, marijuana, nicotine),
- regular smoking,
- serious medical problems (e.g., cancer, diabetes),
- dietary practices that do not allow intake of intervention beverages.
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 |
|---|---|---|
| Black Cherry and Orange Flavored Beverage with added sugarAlso: Kool-Aid®10 oz daily for three weeks | Dietary supplement | Beverage A (Sweetened) |
| Strawberry Kiwi &Lemonade Flavored Beverage with added sugarAlso: Kool-Aid®10 oz daily for three weeks | Dietary supplement | Beverage B (Sweetened) |
| Black Cherry and Orange Flavored Beverage no added sugarAlso: Kool-Aid®10 oz daily for three weeks | Dietary supplement | Beverage A (Unsweetened) |
| Strawberry Kiwi & Lemonade Flavored Beverage no added sugarAlso: Kool-Aid®10 oz daily for three weeks | Dietary supplement | Beverage B (Unsweetened) |
| WaterThree mL administered per associated logo presentation only during MRI procedure. | Other | Beverage A (Sweetened), Beverage A (Unsweetened), Beverage B (Sweetened), Beverage B (Unsweetened) |
Primary outcome
Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo
Time frame: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- > pre-intervention BOLD response to sweetened beverage logo > water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo > water logo for each arm.
3 secondary outcomes
Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)
Time frame: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
Beverage Perceptual Ratings Using Visual Analog Scales
Time frame: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment
Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task
Time frame: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17254636Peirce JW. PsychoPy--Psychophysics software in Python. J Neurosci Methods. 2007 May 15;162(1-2):8-13. doi: 10.1016/j.jneumeth.2006.11.017. Epub 2007 Jan 23.
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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.
Kyle Burger, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Cherry and Orange Flavored Beverage with added sugar, Strawberry Kiwi &Lemonade Flavored Beverage with added sugar and Black Cherry and Orange Flavored Beverage no added sugar in people with Obesity and Weight Gain, run by University of North Carolina, Chapel Hill 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 1 inclusion and 5 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 Apr 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 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. 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 Apr 2023). 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?
Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo (time frame: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment). 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 NCT03490734, which also lists 1 linked publication.
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 Apr 2023.