This trial is active, not recruiting.

Conditions insulin resistance, obesity
Treatments sucralose, sucrose, sucralose + maltodextrin
Sponsor Yale University
Start date December 2014
End date October 2016
Trial size 15 participants
Trial identifier NCT02499705, 100FRI_AFS_pediatric


The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adolescents using fMRI, psychophysical measures, and questionnaires. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Flavored beverage with sucralose.
2 packets
Flavored beverage with sucrose.
equisweet to sucralose
Flavored beverage with Splenda + maltodextrin .
sucralose + maltodextrin
sucralose plus equicaloric (to sucrose) maltodextrin

Primary Outcomes

Ratings of taste sensitivity
time frame: on average 2 weeks

Secondary Outcomes

Insulin resistance and GLP-1
time frame: on average 2 weeks
Ad libitum food intake
time frame: on average 2 weeks
percent signal change of brain response in reward and gustatory areas to taste stimuli
time frame: on average 2 weeks

Eligibility Criteria

Male or female participants from 13 years up to 17 years old.

Inclusion Criteria: - Healthy - Fluent in English - Right handed - 13-17 years old 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 interefere 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.

Additional Information

Official title The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents
Principal investigator Dana M Small, PhD
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. Adolescents may be more sensitive to exposure to AFS because of changes in metabolism during this period of development. Physiologic insulin resistance occurs during adolescence (Moran, Jacobs et al. 1999); this change in insulin sensitivity may predispose adolescents to greater impairments in sweet taste intensity by altering the relationship between sweet taste and post-ingestive reward, as suggested by the Davidson and Swithers model (Davidson and Swithers 2004). Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS use in adolescents, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Yale University.