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

Primary Purpose

Insulin Resistance, Obesity

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

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Fluent in English
  • Right handed
  • 13-17 years old

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 interefere 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

  • The John B. Pierce Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sucralose

Sucrose

Sucralose + maltodextrin

Arm Description

Flavored beverage with sucralose.

Flavored beverage with sucrose.

Flavored beverage with Splenda + maltodextrin .

Outcomes

Primary Outcome Measures

Ratings of taste sensitivity
At baseline and after on average 2 weeks, subjects will rate intensity of sucrose, sucralose, mono potassium glutamate, sodium chloride and citric acid using the General Labeled Magnitude Scale (gLMS). It is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'barely detectable' to 'strongest imaginable' at the top, recoded to 0-100.

Secondary Outcome Measures

Insulin resistance and GLP-1
We will draw a blood sample to assess glucose, insulin and GLP-1
Ad libitum food intake
Subject is offered milk and cereal and asked to consume as much as they want. The amount consumed is measured in weight and converted to calories.
percent signal change of brain response in reward and gustatory areas to taste stimuli
brain response in reward and gustatory areas to sucrose, mono potassium glutamate, sodium chloride and citric acid (in percent signal change).

Full Information

First Posted
January 6, 2015
Last Updated
January 12, 2018
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02499705
Brief Title
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents
Official Title
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Prematurely unblinded based on outcome in other trial. 2 out of 3 particpants in one arm had clinically elevated fasting insulin. Adverse event was reported.
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (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 adolescents using fMRI, psychophysical measures, and questionnaires. 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. Adolescents may be more sensitive to exposure to AFS because of changes in metabolism during this period of development. Physiologic insulin resistance occurs during adolescence (Moran, Jacobs et al. 1999); this change in insulin sensitivity may predispose adolescents to greater impairments in sweet taste intensity by altering the relationship between sweet taste and post-ingestive reward, as suggested by the Davidson and Swithers model (Davidson and Swithers 2004). Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS use in adolescents, 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
Insulin Resistance, Obesity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sucralose
Arm Type
Experimental
Arm Description
Flavored beverage with sucralose.
Arm Title
Sucrose
Arm Type
Experimental
Arm Description
Flavored beverage with sucrose.
Arm Title
Sucralose + maltodextrin
Arm Type
Experimental
Arm Description
Flavored beverage with Splenda + maltodextrin .
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose
Intervention Description
2 packets
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
Primary Outcome Measure Information:
Title
Ratings of taste sensitivity
Description
At baseline and after on average 2 weeks, subjects will rate intensity of sucrose, sucralose, mono potassium glutamate, sodium chloride and citric acid using the General Labeled Magnitude Scale (gLMS). It is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'barely detectable' to 'strongest imaginable' at the top, recoded to 0-100.
Time Frame
on average 2 weeks
Secondary Outcome Measure Information:
Title
Insulin resistance and GLP-1
Description
We will draw a blood sample to assess glucose, insulin and GLP-1
Time Frame
on average 2 weeks
Title
Ad libitum food intake
Description
Subject is offered milk and cereal and asked to consume as much as they want. The amount consumed is measured in weight and converted to calories.
Time Frame
on average 2 weeks
Title
percent signal change of brain response in reward and gustatory areas to taste stimuli
Description
brain response in reward and gustatory areas to sucrose, mono potassium glutamate, sodium chloride and citric acid (in percent signal change).
Time Frame
on average 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Fluent in English Right handed 13-17 years old 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 interefere 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, PhD
Organizational Affiliation
The John B. Pierce Laboratory/Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The John B. Pierce Laboratory
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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