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CompletedNCT02335008AFS_pilotUpdated Jul 15, 2015

The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot

An interventional study of Sucralose and Sucrose in Impairment of Oral Perception, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-15.

Sponsored by Yale University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The goal of this study is to test the hypothesis that repeated consumption of artificial sweetener reduces sweet taste intensity.

Read the detailed description

Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Some studies have found correlations between AFS use and weight gain and/or diabetes [1-4] while others have indicated that AFSs may aid in weight loss [5] or have no effects on body mass index (BMI) [6]. In rats, exposure to AFS leads to reduced chow intake following a sweet preload [7, 8], higher body weight [9, 10] and increased glucose responses and decreased GLP1 release following an oral glucose tolerance test [11] compared to exposure to caloric sweeteners. Given that the five FDA approved AFSs are found in thousands of foods [12] 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 consequences of AFS use, since alterations in sweet taste perception that occur in response to AFS exposure may promote weight gain.

02

Conditions studied

  • Impairment of Oral Perception
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy
  • Fluent in English

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Sucralose

    Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucralose.

    Dietary Supplement: Sucralose

  • Experimental
    Sucrose

    Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucrose.

    Dietary Supplement: Sucrose

Interventions

  • Dietary supplementSucralose

    2 packets per 12 fl oz

  • Dietary supplementSucrose

    equisweet to sucralose

06

What researchers measure

Primary outcomes

  1. Ratings of taste sensitivity

    general labeled magnitude scale ratings of taste intensity

    Time frame: up to one week after intervention

07

Study locations

1 site
  • The John B Pierce Laboratory
    New Haven, Connecticut 06519, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02335008
Lead sponsor
Yale University
Responsible party
Dana M. Small (Associate Professor, Yale University) — Principal investigator
First posted
Jan 9, 2015
Start date
Sep 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Jul 15, 2015

Study contacts

Dana M Small
principal investigator · The John B Pierce Laboratory, Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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