NCT03501238

Brief Summary

Participants will be chosen through an initial sensory test to find high and low-perceivers of astringency. Selected participants will drink a chocolate milk or milk substitute beverage for one week each with washout weeks in between. At the end of each week participants will taste and rate multiple beverages for their astringency and other sensory properties. Participants will provide saliva samples weekly for proteomic analysis and (potentially) analysis of polyphenols. Participants will also be asked to provide a 24 hour dietary recall once per week. Data will be analyzed to determine if there is a relationship between polyphenol exposure, astringency ratings, and salivary protein composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

May 24, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

May 24, 2017

Last Update Submit

May 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relative salivary proteins in saliva

    Measure relative amounts of salivary proteins in participant saliva.

    1 year

Secondary Outcomes (5)

  • Subject Diets

    8 months

  • Chocolate milk flavor ratings

    8 months

  • Chocolate milk substitute flavor ratings

    8 months

  • Chocolate milk substitute with gelatin flavor ratings

    8 months

  • Polyphenol content in saliva samples

    8 months

Study Arms (6)

BSG

EXPERIMENTAL

Participant receives bovine milk, then milk substitute, then milk substitute treated with gelatin

Other: Chocolate MilkOther: Chocolate milk substituteOther: Chocolate milk substitute with gelatin

BGS

EXPERIMENTAL

Participant receives bovine milk, then milk substitute with gelatin, then milk substitute

Other: Chocolate MilkOther: Chocolate milk substituteOther: Chocolate milk substitute with gelatin

SBG

EXPERIMENTAL

Participant receives milk substitute, then bovine milk, then milk substitute with gelatin.

Other: Chocolate MilkOther: Chocolate milk substituteOther: Chocolate milk substitute with gelatin

SGB

EXPERIMENTAL

Participant receives milk substitute, then milk substitute with gelatin, then bovine milk

Other: Chocolate MilkOther: Chocolate milk substituteOther: Chocolate milk substitute with gelatin

GSB

EXPERIMENTAL

Participant receives milk substitute with gelatin, then milk substitute, then bovine milk.

Other: Chocolate MilkOther: Chocolate milk substituteOther: Chocolate milk substitute with gelatin

GBS

EXPERIMENTAL

Participant receives milk substitute with gelatin, then bovine milk, then milk substitute.

Other: Chocolate MilkOther: Chocolate milk substituteOther: Chocolate milk substitute with gelatin

Interventions

Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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Chocolate milk substitute will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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Chocolate milk substitute with gelatin added will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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Eligibility Criteria

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

You may qualify if:

  • High or low perceivers of astringency (from initial screening)

You may not qualify if:

  • Current smokers (within 30 days), dairy/nut/cocoa allergies, piercings in mouth, mid-range perceiver of astringency, issues with taste, smell, swallowing or choking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Feeding BehaviorDysgeusia

Interventions

Gelatin

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorTaste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know the specifics of each beverage they are taking home.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 24, 2017

First Posted

April 18, 2018

Study Start

June 8, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations