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

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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