ClinicalTrials.gg
CompletedNCT03501238Updated May 25, 2023

Interaction of Salivary Proteins and Polyphenols

An interventional study of Chocolate Milk and Chocolate milk substitute in Diet Habit, Diet Modification and Taste, Altered, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Purdue University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diet Habit
  • Diet Modification
  • Taste, Altered
  • Saliva Altered
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 63 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • High or low perceivers of astringency (from initial screening)

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    BSG

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

    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

    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.

    Other: Chocolate Milk · Other: Chocolate milk substitute · Other: Chocolate milk substitute with gelatin

  • Experimental
    SGB

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

    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.

    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.

    Other: Chocolate Milk · Other: Chocolate milk substitute · Other: Chocolate milk substitute with gelatin

Interventions

  • OtherChocolate Milk

    Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

  • OtherChocolate milk substitute

    Chocolate milk substitute will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.

  • OtherChocolate 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.

06

What researchers measure

Primary outcomes

  1. Relative salivary proteins in saliva

    Measure relative amounts of salivary proteins in participant saliva.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 8 months

  2. 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).

    Time frame: 8 months

  3. 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).

    Time frame: 8 months

  4. 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).

    Time frame: 8 months

  5. Polyphenol content in saliva samples

    Measure polyphenol content in expectorated subject saliva samples.

    Time frame: 8 months

07

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47907, United States
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Jan 2018, 6 months.

Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 6 months is below that.

Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2017
First posted
Apr 18, 2018
StartActual
Jun 8, 2017
Primary completionActual
Jan 1, 2018
CompletionActual
Jan 1, 2018
Last update
May 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03501238
Lead sponsor
Purdue University
Responsible party
Cordelia Running, PhD (Assistant Professor, Purdue University) — Principal investigator
First posted
Apr 18, 2018
Start date
Jun 8, 2017
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
May 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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