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Completed

NCT Number: NCT04048681

Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

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.

Completed

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center MRI Research Facility

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diet soda

Behavioral

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

Regular soda

Behavioral

12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)

Other names: Coke, Pepsi

Carbonated Water

Behavioral

12oz can of carbonated water (sparking water, selzter water) unflavored

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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