Clinical trial NCT02335021: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
Official title: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impairment of Oral Perception
Insulin Resistance
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 97
Sex: ALL
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adults. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.

Detailed description: We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Fluent in English
* Right handed

Exclusion Criteria:

* History of oral nerve damage,
* presence of known taste or smell disorder,
* food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),
* history of CNS disease,
* diabetes,
* history of DSM-IV major psychiatric disorder,
* including alcohol and substance abuse,
* chronic use of medication that may affect taste,
* conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies,
* recent smoking history),
* aberrant stimulus ratings,
* contra-indication for fMRI,
* uncomfortable swallowing in supine position,
* discomfort or anxiety associated with insertion an intravenous catheter,
* regular artificial sweetener use.

Primary outcomes:
measure: Ratings of taste sensitivity
timeFrame: up to one week after intervention
Secondary outcomes:
measure: Ad libitum food intake
timeFrame: up to one week after intervention
measure: brain response to taste stimuli
timeFrame: up to one week after intervention
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Dana M Small
role: PRINCIPAL_INVESTIGATOR
References: