Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

January 22, 2020 updated by: Olivia Farr, Beth Israel Deaconess Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center MRI Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 6, 2019

Primary Completion (ACTUAL)

December 20, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (ACTUAL)

August 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P000649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is HIPAA protected and will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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