Interaction of Salivary Proteins and Polyphenols

Diet Habit Clinical Trial

Official title:

Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501238
• Other study ID #: 082-002
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: May 2023
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit
• Diet Modification
• Dysgeusia
• Saliva Altered
• Taste, Altered

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative salivary proteins in saliva	Measure relative amounts of salivary proteins in participant saliva.	1 year
Secondary	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.	8 months
Secondary	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).	8 months
Secondary	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).	8 months
Secondary	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).	8 months
Secondary	Polyphenol content in saliva samples	Measure polyphenol content in expectorated subject saliva samples.	8 months