Obesity
Conditions
Keywords
artificial sweeteners, diet soda
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.
Interventions
BEHAVIORALdiet soda
12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)
BEHAVIORALRegular soda
12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
BEHAVIORALCarbonated Water
12oz can of carbonated water (sparking water, selzter water) unflavored
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain Response to Food Cues in the Insula | 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
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive Testing (Stop Signal Reaction Time) | 1 hour | stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control. |
Countries
United States
Participant flow
Pre-assignment details
This is a cross-over trial, and participants were assigned to receive diet soda, regular soda, and carbonated water in a random order.
Participants by arm
| Arm | Count |
|---|---|
| Diet Soda/Regular Soda/ Carbonated Water The same subjects participated in all three conditions. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | family emergency | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Diet Soda/Regular Soda/ Carbonated Water |
|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 14.1 |
| Body Mass Index (BMI) | 36.1 kg/m^2 STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Soda | Changes in Brain Response to Food Cues in the Insula | 0.25 z-score | Standard Error 0.3 |
| Soda | Changes in Brain Response to Food Cues in the Insula | -0.9 z-score | Standard Error 0.3 |
| Carbonated Water | Changes in Brain Response to Food Cues in the Insula | -0.01 z-score | Standard Error 0.6 |
Secondary
Neurocognitive Testing (Stop Signal Reaction Time)
stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Soda | Neurocognitive Testing (Stop Signal Reaction Time) | 162.6 ms | Standard Error 12.5 |
| Soda | Neurocognitive Testing (Stop Signal Reaction Time) | 172.9 ms | Standard Error 17.4 |
| Carbonated Water | Neurocognitive Testing (Stop Signal Reaction Time) | 180.2 ms | Standard Error 19.9 |