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

Primary Purpose

Impairment of Oral Perception, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sucralose
Sucrose
Sucralose + maltodextrin
Sucralose + Sucrose
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Impairment of Oral Perception

Eligibility Criteria

23 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Sucralose

Sucrose

Sucralose + maltodextrin

Sucralose + Sucrose

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Ratings of taste sensitivity
general labeled magnitude scale ratings of taste intensity

Secondary Outcome Measures

Ad libitum food intake
amount of Mac&Cheese consumed
brain response to taste stimuli
BOLD response as measured by fMRI

Full Information

First Posted
October 24, 2014
Last Updated
September 24, 2019
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02335021
Brief Title
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
Acronym
AFS-adult
Official Title
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impairment of Oral Perception, Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sucralose
Arm Type
Experimental
Arm Description
Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucralose.
Arm Title
Sucrose
Arm Type
Experimental
Arm Description
Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucrose.
Arm Title
Sucralose + maltodextrin
Arm Type
Experimental
Arm Description
Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + maltodextrin .
Arm Title
Sucralose + Sucrose
Arm Type
Experimental
Arm Description
Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + sucrose.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose
Intervention Description
2 packets per 12 fl oz
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrose
Intervention Description
equisweet to sucralose
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose + maltodextrin
Intervention Description
sucralose plus equicaloric (to sucrose) maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose + Sucrose
Intervention Description
half the amount of sucralose plus equicaloric sucrose
Primary Outcome Measure Information:
Title
Ratings of taste sensitivity
Description
general labeled magnitude scale ratings of taste intensity
Time Frame
up to one week after intervention
Secondary Outcome Measure Information:
Title
Ad libitum food intake
Description
amount of Mac&Cheese consumed
Time Frame
up to one week after intervention
Title
brain response to taste stimuli
Description
BOLD response as measured by fMRI
Time Frame
up to one week after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana M Small
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be publicly shared at publication of manuscript.
IPD Sharing Time Frame
De-identified data will be publicly shared at publication of manuscript (anticipated in 2019). Data will be available indefinitely, or at least as long as the hosting platform is available.

Learn more about this trial

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

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