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Interaction of Salivary Proteins and Polyphenols

Primary Purpose

Diet Habit, Diet Modification, Taste, Altered

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chocolate Milk
Chocolate milk substitute
Chocolate milk substitute with gelatin
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diet Habit

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

BSG

BGS

SBG

SGB

GSB

GBS

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Relative salivary proteins in saliva
Measure relative amounts of salivary proteins in participant saliva.

Secondary Outcome Measures

Subject Diets
Collect participant 24 hour dietary recalls to generate data on eating patterns and dietary choices. Analyze correlations with saliva and sensory ratings. Dietary data that will be analyzed include measures such as: fruit and vegetable intake, fat intake (and type of fat). 24 hour recalls will be assess using the ASHA online tool, which collects data on all foods eaten in the last 24 hours.
Chocolate milk flavor ratings
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate milk. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Chocolate milk substitute flavor ratings
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate almond milk. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Chocolate milk substitute with gelatin flavor ratings
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate almond milk with added gelatin. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Polyphenol content in saliva samples
Measure polyphenol content in expectorated subject saliva samples.

Full Information

First Posted
May 24, 2017
Last Updated
May 24, 2023
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT03501238
Brief Title
Interaction of Salivary Proteins and Polyphenols
Official Title
Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Habit, Diet Modification, Taste, Altered, Saliva Altered

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Participants will not know the specifics of each beverage they are taking home.
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BSG
Arm Type
Experimental
Arm Description
Participant receives bovine milk, then milk substitute, then milk substitute treated with gelatin
Arm Title
BGS
Arm Type
Experimental
Arm Description
Participant receives bovine milk, then milk substitute with gelatin, then milk substitute
Arm Title
SBG
Arm Type
Experimental
Arm Description
Participant receives milk substitute, then bovine milk, then milk substitute with gelatin.
Arm Title
SGB
Arm Type
Experimental
Arm Description
Participant receives milk substitute, then milk substitute with gelatin, then bovine milk
Arm Title
GSB
Arm Type
Experimental
Arm Description
Participant receives milk substitute with gelatin, then milk substitute, then bovine milk.
Arm Title
GBS
Arm Type
Experimental
Arm Description
Participant receives milk substitute with gelatin, then bovine milk, then milk substitute.
Intervention Type
Other
Intervention Name(s)
Chocolate Milk
Intervention Description
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
Intervention Name(s)
Chocolate milk substitute
Intervention Description
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
Intervention Name(s)
Chocolate milk substitute with gelatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative salivary proteins in saliva
Description
Measure relative amounts of salivary proteins in participant saliva.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Subject Diets
Description
Collect participant 24 hour dietary recalls to generate data on eating patterns and dietary choices. Analyze correlations with saliva and sensory ratings. Dietary data that will be analyzed include measures such as: fruit and vegetable intake, fat intake (and type of fat). 24 hour recalls will be assess using the ASHA online tool, which collects data on all foods eaten in the last 24 hours.
Time Frame
8 months
Title
Chocolate milk flavor ratings
Description
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate milk. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Time Frame
8 months
Title
Chocolate milk substitute flavor ratings
Description
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate almond milk. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Time Frame
8 months
Title
Chocolate milk substitute with gelatin flavor ratings
Description
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate almond milk with added gelatin. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Time Frame
8 months
Title
Polyphenol content in saliva samples
Description
Measure polyphenol content in expectorated subject saliva samples.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.

Learn more about this trial

Interaction of Salivary Proteins and Polyphenols

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