Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Regular soda; Behavioral: diet soda; Behavioral: Carbonated Water

• Registration Number: NCT04048681
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-06
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-01
• Results First Submitted: 2020-01-10
• Results First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Results First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soda	Regular soda	12oz can of Coke
Diet Soda	diet soda	12oz can of Diet Coke
Carbonated Water	Carbonated Water	12oz can of carbonated (unflavored) water

Primary Outcome Measures

Name	Time	Method
Changes in Brain Response to Food Cues in the Insula	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

Name	Time	Method
Neurocognitive Testing (Stop Signal Reaction Time)	1 hour	stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center MRI Research Facility; 🇺🇸 Boston, Massachusetts, United States