Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

Obesity Clinical Trial

Official title:

Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048681
• Other study ID #: 2019P000649
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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)
• Regular soda
12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
• Carbonated Water
12oz can of carbonated water (sparking water, selzter water) unflavored

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center MRI Research Facility	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour
Secondary	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.	1 hour