ObesityNCT04048681
Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
A study testing diet soda, Regular soda and Carbonated Water in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study seeks to determine whether artificial sweeteners in the context of diet soda may alter the brain's response to food cues and thus impact appetite. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- diet soda, Regular soda and Carbonated Water
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2019to 20 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women who are 18-65 years old, with a BMI >30kg/m2.
Who cannot join
- Unable or unwilling to participate in the study for any reason
- Metal in the body or other safety concerns which makes patient unable to have an MRI
- Pregnant women will be excluded to protect the fetus against potential effects of a non-medically required MRI on fetal development and difficulty of measuring accurate BMI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center MRI Research Facility
Boston, Massachusetts, 02215
About this study
This study seeks to determine whether artificial sweeteners in the context of diet soda may alter the brain's response to food cues and thus impact appetite.
- Conditions
- Obesity
- Being tested
- diet soda, Regular soda, Carbonated Water
- Keywords
- artificial sweeteners, diet soda
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet sodaBehavioural
Also called Diet Coke, Diet Pepsi
12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)
Regular sodaBehavioural
Also called Coke, Pepsi
12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
Carbonated WaterBehavioural
12oz can of carbonated water (sparking water, selzter water) unflavored
| Study group | Role | What they receive |
|---|---|---|
| Diet Soda | Experimental | 12oz can of Diet Coke Receives: Behavioral: diet soda |
| Soda | Active comparator | 12oz can of Coke Receives: Behavioral: Regular soda |
| Carbonated Water | Placebo comparator | 12oz can of carbonated (unflavored) water Receives: Behavioral: Carbonated Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brain Response to Food Cues in the Insula
Functional magnetic resonance imaging (BOLD signals) while patients view food vs. non-food cues. The effect size z-score represents the magnitude of the activation in that area to food cues vs. non-food cues. The z-score is the estimated response magnitude in that area compared to the overall mean. Negative numbers indicate values lower than the mean and positive numbers indicate values above the mean.
Measured: 1 hour
Secondary outcomes (1)
Neurocognitive Testing (Stop Signal Reaction Time)
stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start6 Aug 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 ObesityStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia Farr, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048681
- Sponsor's protocol ID
- 2019P000649
- Status last verified
- Jan 2020
- First submitted
- 6 Aug 2019
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is HIPAA protected and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
- ClinicalTrials.gov ID
- NCT04048681
- Acronym / sponsor ID
- 2019P000649
- Conditions
- Obesity
- Keywords
- artificial sweeteners, diet soda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to determine whether artificial sweeteners in the context of diet soda may alter the brain's response to food cues and thus impact appetite.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet Soda | Experimental | Behavioral: diet soda12oz can of Diet Coke |
| Soda | Active comparator | Behavioral: Regular soda12oz can of Coke |
| Carbonated Water | Placebo comparator | Behavioral: Carbonated Water12oz can of carbonated (unflavored) water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women who are 18-65 years old, with a BMI >30kg/m2.
Key exclusion criteria (3 listed)
- Unable or unwilling to participate in the study for any reason
- Metal in the body or other safety concerns which makes patient unable to have an MRI
- Pregnant women will be excluded to protect the fetus against potential effects of a non-medically required MRI on fetal development and difficulty of measuring accurate BMI.
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 |
|---|---|---|
| diet sodaAlso: Diet Coke, Diet Pepsi12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas) | Behavioural | Diet Soda |
| Regular sodaAlso: Coke, Pepsi12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas) | Behavioural | Soda |
| Carbonated Water12oz can of carbonated water (sparking water, selzter water) unflavored | Behavioural | Carbonated Water |
Primary outcome
Changes in Brain Response to Food Cues in the Insula
Time frame: 1 hour
Functional magnetic resonance imaging (BOLD signals) while patients view food vs. non-food cues. The effect size z-score represents the magnitude of the activation in that area to food cues vs. non-food cues. The z-score is the estimated response magnitude in that area compared to the overall mean. Negative numbers indicate values lower than the mean and positive numbers indicate values above the mean.
1 secondary outcome
Neurocognitive Testing (Stop Signal Reaction Time)
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data is HIPAA protected and will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet soda, Regular soda and Carbonated Water in people with Obesity, run by Beth Israel Deaconess Medical Center 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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. 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 5 Feb 2020). 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?
Changes in Brain Response to Food Cues in the Insula (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.