Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04048681
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: diet soda; Behavioral: Regular soda; Behavioral: Carbonated Water	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
• Actual Study Start Date: Aug 6, 2019
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet Soda 12oz can of Diet Coke	Behavioral: 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); Other Names: Diet Coke Diet Pepsi
Active Comparator: Soda 12oz can of Coke	Behavioral: Regular soda; 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas); Other Names: Coke Pepsi
Placebo Comparator: Carbonated Water 12oz can of carbonated (unflavored) water	Behavioral: Carbonated Water; 12oz can of carbonated water (sparking water, selzter water) unflavored

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center MRI Research Facility	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2019

More Information

Publications

None provided.

• Responsible Party: Olivia Farr, Instructor in Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04048681
• Other Study ID Numbers: 2019P000649
• First Posted: Aug 7, 2019
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Olivia Farr, Instructor in Medicine, Beth Israel Deaconess Medical Center: artificial sweeteners; diet soda
• Additional relevant MeSH terms: Cocaine

Study Results

Participant Flow

Pre-assignment Detail	This is a cross-over trial, and participants were assigned to receive diet soda, regular soda, and carbonated water in a random order.

Arm/Group Title	Diet Soda Then Regular Soda Then Carbonated Water	Regular Soda Then Carbonated Water Then Diet Soda	Carbonated Water Then Diet Soda Then Regular Soda	Regular Soda Then Diet Soda Then Carbonated Water	Diet Soda Then Carbonated Water Then Regular Soda
Arm/Group Description	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	1	1	1	1	1
COMPLETED	1	1	1	0	1
NOT COMPLETED	0	0	0	1	0

Baseline Characteristics

Arm/Group Title	Diet Soda/Regular Soda/ Carbonated Water
Arm/Group Description	The same subjects participated in all three conditions.
Overall Participants	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.6 (14.1)
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 20%
Not Hispanic or Latino	4 80%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 40%
White	3 60%
More than one race	0 0%
Unknown or Not Reported	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	36.1 (5.4)

Outcome Measures

1. Primary Outcome

Title	Changes in Brain Response to Food Cues in the Insula
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet Soda	Soda	Carbonated Water
Arm/Group Description	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)	12oz can of Coke Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)	12oz can of carbonated (unflavored) water Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored
Measure Participants	5	5	4
Mean (Standard Error) [z-score]	0.25 (0.3)	-0.9 (0.3)	-0.01 (0.6)

2. Secondary Outcome

Title	Neurocognitive Testing (Stop Signal Reaction Time)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet Soda	Soda	Carbonated Water
Arm/Group Description	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)	12oz can of Coke Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)	12oz can of carbonated (unflavored) water Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored
Measure Participants	5	5	4
Mean (Standard Error) [ms]	162.6 (12.5)	172.9 (17.4)	180.2 (19.9)

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Diet Soda		Soda		Carbonated Water
Arm/Group Description	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)		12oz can of Coke Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)		12oz can of carbonated (unflavored) water Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored
All Cause Mortality
	Diet Soda		Soda		Carbonated Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/4 (0%)
Serious Adverse Events
	Diet Soda		Soda		Carbonated Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Diet Soda		Soda		Carbonated Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.