NCT02335021

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

4.3 years

First QC Date

October 24, 2014

Last Update Submit

September 24, 2019

Conditions

Impairment of Oral PerceptionInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Ratings of taste sensitivity

    general labeled magnitude scale ratings of taste intensity

    up to one week after intervention

Secondary Outcomes (2)

  • Ad libitum food intake

    up to one week after intervention

  • brain response to taste stimuli

    up to one week after intervention

Study Arms (4)

Sucralose

EXPERIMENTAL

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

Sucrose

EXPERIMENTAL

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

Sucralose + maltodextrin

EXPERIMENTAL

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 + Sucrose

EXPERIMENTAL

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

Interventions

SucraloseDIETARY_SUPPLEMENT

2 packets per 12 fl oz

Sucralose
SucroseDIETARY_SUPPLEMENT

equisweet to sucralose

Sucrose
Sucralose + maltodextrinDIETARY_SUPPLEMENT

sucralose plus equicaloric (to sucrose) maltodextrin

Sucralose + maltodextrin
Sucralose + SucroseDIETARY_SUPPLEMENT

half the amount of sucralose plus equicaloric sucrose

Sucralose + Sucrose

Eligibility Criteria

Age23 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Fluent in English
  • Right handed

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

trichlorosucroseSucrosemaltodextrin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Dana M Small

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

January 9, 2015

Study Start

January 1, 2015

Primary Completion

April 24, 2019

Study Completion

April 24, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

De-identified data will be publicly shared at publication of manuscript.

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.

Locations

US(1)