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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02335021
Other study ID # 0405026766-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date April 24, 2019

Study information

Verified date September 2019
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date April 24, 2019
Est. primary completion date April 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Sucralose
2 packets per 12 fl oz
Sucrose
equisweet to sucralose
Sucralose + maltodextrin
sucralose plus equicaloric (to sucrose) maltodextrin
Sucralose + Sucrose
half the amount of sucralose plus equicaloric sucrose

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ratings of taste sensitivity general labeled magnitude scale ratings of taste intensity up to one week after intervention
Secondary Ad libitum food intake amount of Mac&Cheese consumed up to one week after intervention
Secondary brain response to taste stimuli BOLD response as measured by fMRI up to one week after intervention
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