- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335008
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot (AFS_pilot)
July 14, 2015 updated by: Dana M. Small, Yale University
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot Study
The goal of this study is to test the hypothesis that repeated consumption of artificial sweetener reduces sweet taste intensity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- The John B Pierce Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- Fluent in English
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
2 packets per 12 fl oz
|
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.
|
equisweet to sucralose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratings of taste sensitivity
Time Frame: up to one week after intervention
|
general labeled magnitude scale ratings of taste intensity
|
up to one week after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dana M Small, The John B Pierce Laboratory, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
October 24, 2014
First Submitted That Met QC Criteria
January 8, 2015
First Posted (Estimate)
January 9, 2015
Study Record Updates
Last Update Posted (Estimate)
July 15, 2015
Last Update Submitted That Met QC Criteria
July 14, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 0405026766-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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