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Trial record 32 of 537 for:    Taste Disorders AND taste

Interaction of Salivary Proteins and Polyphenols

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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

Tracking Information
First Submitted Date  ICMJE May 24, 2017
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date April 17, 2018
Actual Study Start Date  ICMJE June 8, 2017
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Relative salivary proteins in saliva [ Time Frame: 1 year ]
Measure relative amounts of salivary proteins in participant saliva.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
  • 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.
  • 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).
  • 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).
  • 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).
  • Polyphenol content in saliva samples [ Time Frame: 8 months ]
    Measure polyphenol content in expectorated subject saliva samples.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interaction of Salivary Proteins and Polyphenols
Official Title  ICMJE Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Diet Habit
  • Diet Modification
  • Taste, Altered
  • Saliva Altered
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: BSG
    Participant receives bovine milk, then milk substitute, then milk substitute treated with gelatin
    Interventions:
    • Other: Chocolate Milk
    • Other: Chocolate milk substitute
    • Other: Chocolate milk substitute with gelatin
  • Experimental: BGS
    Participant receives bovine milk, then milk substitute with gelatin, then milk substitute
    Interventions:
    • Other: Chocolate Milk
    • Other: Chocolate milk substitute
    • Other: Chocolate milk substitute with gelatin
  • Experimental: SBG
    Participant receives milk substitute, then bovine milk, then milk substitute with gelatin.
    Interventions:
    • Other: Chocolate Milk
    • Other: Chocolate milk substitute
    • Other: Chocolate milk substitute with gelatin
  • Experimental: SGB
    Participant receives milk substitute, then bovine milk, then milk substitute with gelatin
    Interventions:
    • Other: Chocolate Milk
    • Other: Chocolate milk substitute
    • Other: Chocolate milk substitute with gelatin
  • Experimental: GSB
    Participant receives milk substitute with gelatin, then milk substitute, then bovine milk.
    Interventions:
    • Other: Chocolate Milk
    • Other: Chocolate milk substitute
    • Other: Chocolate milk substitute with gelatin
  • Experimental: GBS
    Participant receives milk substitute with gelatin, then bovine milk, then milk substitute.
    Interventions:
    • Other: Chocolate Milk
    • Other: Chocolate milk substitute
    • Other: Chocolate milk substitute with gelatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2018)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03501238
Other Study ID Numbers  ICMJE 082-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared.
Responsible Party Cordelia Running, PhD, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Purdue University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP