Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions

April 15, 2025 updated by: PepsiCo Global R&D
To determine the effect of flavored, carbonated drinks on salivary flow rate, saliva composition, and taste perceptions compared with control drinks (water, carbonated water, non-carbonated)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Previous studies have shown that drinking a beverage can stimulate the production of saliva and alter its composition. These effects could impact oral processing and taste perceptions. Various ingredients in beverages such as carbonation may affect saliva and oral processing. The objective of this study is to determine the effect of flavored carbonated beverages on salivary flow rate, saliva composition (pH, mucins, carbonic anhydrase, and total protein), and taste perceptions compared with unflavored and non-carbonated control drinks.

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flavored carbonated drink 1
Flavored carbonated beverage with nutritive sweeteners
Other: Beverage
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
Other: Beverage
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
Experimental: Flavored drink
Flavored non-carbonated beverage with nutritive sweeteners
Other: Beverage
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
Other: Beverage
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
Experimental: Carbonated Water
Unflavored carbonated water
Other: Beverage
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants
Experimental: Water
Plain, unflavored, non-carbonated water
Other: Beverage
15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants

What is the study measuring?

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

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

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: Lindsay Baker, PhD, PepsiCo, Inc. Sports Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2025

Primary Completion (Estimated)

June 13, 2025

Study Completion (Estimated)

June 29, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEP-2423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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