NCT02499705

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

January 6, 2015

Last Update Submit

January 12, 2018

Conditions

Insulin ResistanceObesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    on average 2 weeks

Secondary Outcomes (3)

  • Insulin resistance and GLP-1

    on average 2 weeks

  • Ad libitum food intake

    on average 2 weeks

  • percent signal change of brain response in reward and gustatory areas to taste stimuli

    on average 2 weeks

Study Arms (3)

Sucralose

EXPERIMENTAL

Flavored beverage with sucralose.

Dietary Supplement: Sucralose

Sucrose

EXPERIMENTAL

Flavored beverage with sucrose.

Dietary Supplement: Sucrose

Sucralose + maltodextrin

EXPERIMENTAL

Flavored beverage with Splenda + maltodextrin .

Dietary Supplement: Sucralose + maltodextrin

Interventions

SucraloseDIETARY_SUPPLEMENT

2 packets

Sucralose
SucroseDIETARY_SUPPLEMENT

equisweet to sucralose

Sucrose
Sucralose + maltodextrinDIETARY_SUPPLEMENT

sucralose plus equicaloric (to sucrose) maltodextrin

Sucralose + maltodextrin

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy
  • Fluent in English
  • Right handed
  • years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The John B. Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

trichlorosucroseSucrosemaltodextrin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Dana M Small, PhD

    The John B. Pierce Laboratory/Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

July 16, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

US(1)