NCT02646956

Brief Summary

The goal of the study is to determine whether there are age-, diet- and genetically-related differences in the perception of sweeteners, both nutritive and non-nutritive.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

December 18, 2015

Last Update Submit

January 4, 2016

Conditions

Development

Keywords

Sweet TastePsychophysicsGeneticsDietAgeNonnutritive Sweetener

Outcome Measures

Primary Outcomes (3)

  • Liking for the taste of sweeteners measured via the 3-point facial hedonic scale.

    Through study completion, an average of 6 months.

  • Liking for the taste of sweeteners measured via the 5-point facial hedonic scale

    Through study completion, an average of 6 months.

  • Liking for the taste of sweeteners measured via the Monell forced-choice, paired-comparison tracking procedure.

    Through study completion, an average of 6 months.

Secondary Outcomes (3)

  • Genotyping of taste receptor genes via saliva donation

    Through study completion, an average of 6 months

  • BMI calculated from body weight and height measures

    Through study completion, an average of 6 months

  • One day dietary intake collected via the Automated Self-Administered 24-hour dietary recall (ASA24).

    Through study completion, an average of 6 months

Study Arms (2)

Age Group-Children

Children between ages of 7 and 14

Other: sweeteners

Age Group-Adults

Healthy adults who are the parent of the children

Other: sweeteners

Interventions

sweetenersOTHER

Participants tasted a variety of nutritive and nonnutritive sweeteners

Age Group-AdultsAge Group-Children

Eligibility Criteria

Age7 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy children and adults living in the Philadelphia area

You may qualify if:

  • Healthy

You may not qualify if:

  • Allergies and taking medication that affected taste

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Salivary samples obtained for genotyping of taste receptor genes

MeSH Terms

Interventions

Sweetening Agents

Intervention Hierarchy (Ancestors)

Flavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Julie A Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2015

First Posted

January 6, 2016

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 6, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share