Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

NCT ID: NCT04048681

Last Updated: 2020-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-06

Study Completion Date

2019-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diet Soda

12oz can of Diet Coke

Group Type EXPERIMENTAL

diet soda

Intervention Type BEHAVIORAL

12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)

Soda

12oz can of Coke

Group Type ACTIVE_COMPARATOR

Regular soda

Intervention Type BEHAVIORAL

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

Carbonated Water

12oz can of carbonated (unflavored) water

Group Type PLACEBO_COMPARATOR

Carbonated Water

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type BEHAVIORAL

Regular soda

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

Intervention Type BEHAVIORAL

Carbonated Water

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diet Coke Diet Pepsi Coke Pepsi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olivia Farr

Instructor in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Deaconess Medical Center MRI Research Facility

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019P000649

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fizzy Drinks Study
NCT02735889 COMPLETED NA