Trial Outcomes & Findings for Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas (NCT NCT04048681)
NCT ID: NCT04048681
Last Updated: 2020-02-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
1 hour
Results posted on
2020-02-05
Participant Flow
This is a cross-over trial, and participants were assigned to receive diet soda, regular soda, and carbonated water in a random order.
Participant milestones
| Measure |
Diet Soda Then Regular Soda Then Carbonated Water
Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of regular soda, 7 days washout, then third visit with 12 oz can of carbonated water.
|
Regular Soda Then Carbonated Water Then Diet Soda
Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of diet soda.
|
Carbonated Water Then Diet Soda Then Regular Soda
Participant had first visit with 12oz can of carbonated water, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of regular soda.
|
Regular Soda Then Diet Soda Then Carbonated Water
Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of carbonated water.
|
Diet Soda Then Carbonated Water Then Regular Soda
Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of regular soda.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Diet Soda Then Regular Soda Then Carbonated Water
Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of regular soda, 7 days washout, then third visit with 12 oz can of carbonated water.
|
Regular Soda Then Carbonated Water Then Diet Soda
Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of diet soda.
|
Carbonated Water Then Diet Soda Then Regular Soda
Participant had first visit with 12oz can of carbonated water, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of regular soda.
|
Regular Soda Then Diet Soda Then Carbonated Water
Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of carbonated water.
|
Diet Soda Then Carbonated Water Then Regular Soda
Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of regular soda.
|
|---|---|---|---|---|---|
|
Overall Study
family emergency
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
Baseline characteristics by cohort
| Measure |
Diet Soda/Regular Soda/ Carbonated Water
n=5 Participants
The same subjects participated in all three conditions.
|
|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
36.1 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourFunctional 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.
Outcome measures
| Measure |
Diet Soda
n=5 Participants
12oz can of Diet Coke
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)
|
Soda
n=5 Participants
12oz can of Coke
Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
|
Carbonated Water
n=4 Participants
12oz can of carbonated (unflavored) water
Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored
|
|---|---|---|---|
|
Changes in Brain Response to Food Cues in the Insula
|
0.25 z-score
Standard Error 0.3
|
-0.9 z-score
Standard Error 0.3
|
-0.01 z-score
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 1 hourstop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control.
Outcome measures
| Measure |
Diet Soda
n=5 Participants
12oz can of Diet Coke
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)
|
Soda
n=5 Participants
12oz can of Coke
Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
|
Carbonated Water
n=4 Participants
12oz can of carbonated (unflavored) water
Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored
|
|---|---|---|---|
|
Neurocognitive Testing (Stop Signal Reaction Time)
|
162.6 ms
Standard Error 12.5
|
172.9 ms
Standard Error 17.4
|
180.2 ms
Standard Error 19.9
|
Adverse Events
Diet Soda
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soda
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Carbonated Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place