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Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048681
Recruitment Status : Completed
First Posted : August 7, 2019
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Olivia Farr, Beth Israel Deaconess Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: diet soda Behavioral: Regular soda Behavioral: Carbonated Water Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
Actual Study Start Date : August 6, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Diet Soda
12oz can of Diet Coke
 Behavioral: diet soda
12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)
Other Names:
  • Diet Coke
  • Diet Pepsi
Active Comparator: Soda
12oz can of Coke
 Behavioral: Regular soda
12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
Other Names:
  • Coke
  • Pepsi
Placebo Comparator: Carbonated Water
12oz can of carbonated (unflavored) water
 Behavioral: Carbonated Water
12oz can of carbonated water (sparking water, selzter water) unflavored


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neurocognitive Testing (Stop Signal Reaction Time) [ Time Frame: 1 hour ]
    stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women who are 18-65 years old, with a BMI >30kg/m2.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048681


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center MRI Research Facility
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
  Study Documents (Full-Text)

Documents provided by Olivia Farr, Beth Israel Deaconess Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 2, 2019

More Information
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Responsible Party: Olivia Farr, Instructor in Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04048681    
Other Study ID Numbers: 2019P000649
First Posted: August 7, 2019    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is HIPAA protected and will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olivia Farr, Beth Israel Deaconess Medical Center:
artificial sweeteners
diet soda
Additional relevant MeSH terms:
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Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
 Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents