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The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults (AFS-adult)

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ClinicalTrials.gov Identifier: NCT02335021
Recruitment Status : Recruiting
First Posted : January 9, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Impairment of Oral Perception Insulin Resistance Dietary Supplement: Sucralose Dietary Supplement: Sucrose Dietary Supplement: Sucralose + maltodextrin Dietary Supplement: Sucralose + Sucrose Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
Study Start Date : January 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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.
Dietary Supplement: 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.
Dietary Supplement: Sucrose
equisweet to sucralose

Experimental: Sucralose + maltodextrin
Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + maltodextrin .
Dietary Supplement: Sucralose + maltodextrin
sucralose plus equicaloric (to sucrose) maltodextrin

Experimental: Sucralose + Sucrose
Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + sucrose.
Dietary Supplement: Sucralose + Sucrose
half the amount of sucralose plus equicaloric sucrose




Primary Outcome Measures :
  1. Ratings of taste sensitivity [ Time Frame: up to one week after intervention ]
    general labeled magnitude scale ratings of taste intensity


Secondary Outcome Measures :
  1. Ad libitum food intake [ Time Frame: up to one week after intervention ]
    amount of Mac&Cheese consumed

  2. brain response to taste stimuli [ Time Frame: up to one week after intervention ]
    BOLD response as measured by fMRI



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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335021


Contacts
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Contact: Dana M Small 2037854158 dana.small@yale.edu
Contact: Elizabeth Garcia 2037857646 elizabeth.garcia@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Dana M Small, PhD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Dana M Small Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02335021     History of Changes
Other Study ID Numbers: 0405026766-2
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases