NCT02335008

Brief Summary

The goal of this study is to test the hypothesis that repeated consumption of artificial sweetener reduces sweet taste intensity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 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

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

October 24, 2014

Last Update Submit

July 14, 2015

Conditions

Impairment of Oral Perception

Outcome Measures

Primary Outcomes (1)

  • Ratings of taste sensitivity

    general labeled magnitude scale ratings of taste intensity

    up to one week after intervention

Study Arms (2)

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

Interventions

SucraloseDIETARY_SUPPLEMENT

2 packets per 12 fl oz

Sucralose
SucroseDIETARY_SUPPLEMENT

equisweet to sucralose

Sucrose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Fluent in English

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.

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

Interventions

trichlorosucroseSucrose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Dana M Small

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2014

First Posted

January 9, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

US(1)