Interaction of Salivary Proteins and Polyphenols
Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
1 other identifier
interventional
63
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedMay 25, 2023
May 1, 2023
7 months
May 24, 2017
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
EXPERIMENTALParticipant receives bovine milk, then milk substitute, then milk substitute treated with gelatin
BGS
EXPERIMENTALParticipant receives bovine milk, then milk substitute with gelatin, then milk substitute
SBG
EXPERIMENTALParticipant receives milk substitute, then bovine milk, then milk substitute with gelatin.
SGB
EXPERIMENTALParticipant receives milk substitute, then milk substitute with gelatin, then bovine milk
GSB
EXPERIMENTALParticipant receives milk substitute with gelatin, then milk substitute, then bovine milk.
GBS
EXPERIMENTALParticipant receives milk substitute with gelatin, then bovine milk, then milk substitute.
Interventions
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 will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.