N/A
N=5
Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04048681 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Changes in Brain Response to Food Cues in the Insula — 0.25; -0.9; -0.01 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- diet soda (Behavioral); Regular soda (Behavioral); Carbonated Water (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Brain Response to Food Cues in the Insula |
0.25; -0.9; -0.01 | — |
| SECONDARY Neurocognitive Testing (Stop Signal Reaction Time) |
162.6; 172.9; 180.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04048681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.