Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interaction of Salivary Proteins and Polyphenols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501238
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Cordelia Running, PhD, Purdue University

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.

Condition or disease Intervention/treatment Phase
Diet Habit Diet Modification Taste, Altered Saliva Altered Other: Chocolate Milk Other: Chocolate milk substitute Other: Chocolate milk substitute with gelatin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Participants will not know the specifics of each beverage they are taking home.
Primary Purpose: Basic Science
Official Title: Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Arm Intervention/treatment
Experimental: BSG
Participant receives bovine milk, then milk substitute, then milk substitute treated with gelatin
Other: Chocolate Milk
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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.

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.

Experimental: BGS
Participant receives bovine milk, then milk substitute with gelatin, then milk substitute
Other: Chocolate Milk
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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.

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.

Experimental: SBG
Participant receives milk substitute, then bovine milk, then milk substitute with gelatin.
Other: Chocolate Milk
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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.

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.

Experimental: SGB
Participant receives milk substitute, then bovine milk, then milk substitute with gelatin
Other: Chocolate Milk
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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.

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.

Experimental: GSB
Participant receives milk substitute with gelatin, then milk substitute, then bovine milk.
Other: Chocolate Milk
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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.

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.

Experimental: GBS
Participant receives milk substitute with gelatin, then bovine milk, then milk substitute.
Other: Chocolate Milk
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

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.

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.




Primary Outcome Measures :
  1. Relative salivary proteins in saliva [ Time Frame: 1 year ]
    Measure relative amounts of salivary proteins in participant saliva.


Secondary Outcome Measures :
  1. Subject Diets [ Time Frame: 8 months ]
    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.

  2. Chocolate milk flavor ratings [ Time Frame: 8 months ]
    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).

  3. Chocolate milk substitute flavor ratings [ Time Frame: 8 months ]
    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).

  4. Chocolate milk substitute with gelatin flavor ratings [ Time Frame: 8 months ]
    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).

  5. Polyphenol content in saliva samples [ Time Frame: 8 months ]
    Measure polyphenol content in expectorated subject saliva samples.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501238


Locations
Layout table for location information
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University

Layout table for additonal information
Responsible Party: Cordelia Running, PhD, Assistant Professor, Purdue University
ClinicalTrials.gov Identifier: NCT03501238     History of Changes
Other Study ID Numbers: 082-002
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dysgeusia
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms