Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

NCT04048681 | Completed Results

• 1 other identifier: 2019P000649
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

artificial sweeteners; diet soda

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neurocognitive Testing (Stop Signal Reaction Time)

  1 hour

Study Arms (3)

Diet Soda

EXPERIMENTAL

12oz can of Diet Coke

Behavioral: diet soda

Soda

ACTIVE COMPARATOR

12oz can of Coke

Behavioral: Regular soda

Carbonated Water

PLACEBO COMPARATOR

12oz can of carbonated (unflavored) water

Behavioral: Carbonated Water

Interventions

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)

Also known as: Diet Coke, Diet Pepsi

Diet Soda

Regular soda BEHAVIORAL

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

Also known as: Coke, Pepsi

Soda

Carbonated Water BEHAVIORAL

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

Carbonated Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center MRI Research Facility

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Coke; Carbonated Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coal; Fossil Fuels; Complex Mixtures; Energy-Generating Resources; Environment; Environment and Public Health; Mineral Waters; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Carbonated Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Drinking Water; Food and Beverages

Results Point of Contact

• Title: Dr. Olivia Farr
• Organization: Beth Israel Deaconess Medical Center

ofarr@bidmc.harvard.edu

6176678636

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: August 6, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)