Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Lindsay Baker, PhD
- Phone Number: 814-883-9454
- Email: lindsay.baker@pepsico.com
Study Locations
-
-
New York
-
Valhalla, New York, United States, 10595
- Gatorade Sports Science Institute
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject is male or female
- If female, subject is not pregnant or nursing (based on self-report)
- Subject is 18-45 years of age, inclusive
- Subject is a regular consumer of carbonated drinks (questionnaire)
- Subject is willing to avoid alcohol consumption 24 hours prior to visits
- Subject is willing to fast (no food or gum) for 2 hours prior to study sessions
- Able to speak, write, and read English
- Provision of written consent to participate
Exclusion Criteria:
- Subject smokes, vapes, or uses any nicotine/tobacco products (or has quit for less than 6 months)
- Subject currently has or recently had an illness (cold, flu, COVID) within the past month
- Subject has a condition affecting the oral cavity such as Xerostomia (dry mouth), Sores/lesions, Untreated dental caries, Major dental implants/appliances (including dentures)
- Subject has a reduced sense of taste (dysgeusia) or smell (parosmia)
- Subject has a health condition that would interfere with the study as indicated on the general health questionnaire (GHQ) (including cardiovascular, renal, or metabolic diseases)
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 6 months
- Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
- Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any PepsiCo product. If subject is unsure if a company would be considered a competitor to PepsiCo, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Flavored carbonated drink 1
Flavored carbonated beverage with nutritive sweeteners
|
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
|
|
Experimental: Flavored carbonated drink 2
Flavored carbonated beverage with non-nutritive sweeteners
|
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
|
|
Experimental: Flavored drink
Flavored non-carbonated beverage with nutritive sweeteners
|
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
|
|
Experimental: Flavored non-carbonated drink
Flavored non-carbonated beverage with non-nutritive sweeteners
|
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
|
|
Experimental: Carbonated Water
Unflavored carbonated water
|
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
|
|
Experimental: Water
Plain, unflavored, non-carbonated water
|
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary flow rate
Time Frame: At each of six 2 hour test sessions 2-8 days apart at same time of day
|
5 minute passive drool saliva and 10 minute filter paper saliva (one sample each from tongue and palate) collected in a fixed sequence of tastant flavors (same for each session) and the assigned test beverage intervention (different for each session)
|
At each of six 2 hour test sessions 2-8 days apart at same time of day
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary pH
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
Lab test
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
|
Saliva carbonic anhydrase concentration
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
Lab test, unit mg/L
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
|
Saliva total protein concentration
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
Lab test, unit mg/ml
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
|
Saliva mucin 5B concentration Saliva mucin 5B concentration
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
Lab test, unit micrograms/ml
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
|
Saliva mucin 7 concentration
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
Lab test, unit micrograms/ml
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
|
Taste perceptions
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day.
|
Labeled Magnitude Scale (LMS)) of intensity of perception rated from barely detectable to strongest imaginable (tastants such as sweet, sour, salty, bitter, umami).
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day.
|
|
Beverage liking
Time Frame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
9-point hedonic scale rating from 1=Dislike extremely to 9= Like extremely
|
Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
|
|
Adverse Events
Time Frame: Symptoms reported at each test day and between visits from Screening to test day six
|
Safety
|
Symptoms reported at each test day and between visits from Screening to test day six
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Lindsay Baker, PhD, PepsiCo, Inc. Sports Science
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PEP-2423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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