Interaction of Salivary Proteins and Polyphenols

NCT ID: NCT03501238

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diet Habit Diet Modification Taste, Altered Saliva Altered

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not know the specifics of each beverage they are taking home.

Study Groups

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BSG

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

Group Type EXPERIMENTAL

Chocolate Milk

Intervention Type OTHER

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

Chocolate milk substitute

Intervention Type OTHER

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

Chocolate milk substitute with gelatin

Intervention Type OTHER

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.

BGS

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

Group Type EXPERIMENTAL

Chocolate Milk

Intervention Type OTHER

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

Chocolate milk substitute

Intervention Type OTHER

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

Chocolate milk substitute with gelatin

Intervention Type OTHER

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.

SBG

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

Group Type EXPERIMENTAL

Chocolate Milk

Intervention Type OTHER

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

Chocolate milk substitute

Intervention Type OTHER

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

Chocolate milk substitute with gelatin

Intervention Type OTHER

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.

SGB

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

Group Type EXPERIMENTAL

Chocolate Milk

Intervention Type OTHER

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

Chocolate milk substitute

Intervention Type OTHER

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

Chocolate milk substitute with gelatin

Intervention Type OTHER

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.

GSB

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

Group Type EXPERIMENTAL

Chocolate Milk

Intervention Type OTHER

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

Chocolate milk substitute

Intervention Type OTHER

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

Chocolate milk substitute with gelatin

Intervention Type OTHER

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.

GBS

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

Group Type EXPERIMENTAL

Chocolate Milk

Intervention Type OTHER

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

Chocolate milk substitute

Intervention Type OTHER

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

Chocolate milk substitute with gelatin

Intervention Type OTHER

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.

Interventions

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Chocolate Milk

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

Intervention Type OTHER

Chocolate milk substitute

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

Intervention Type OTHER

Chocolate milk substitute with gelatin

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Cordelia Running, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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082-002

Identifier Type: -

Identifier Source: org_study_id

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