Clinical trial NCT06933290: Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions
Official title: Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Taste Perception
Saliva Production
Keywords: taste
saliva
food pairing
salivary protein
mucin
salivary flow rate
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2025-04-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Salivary flow rate
timeFrame: At each of six 2 hour test sessions 2-8 days apart at same time of day
Secondary outcomes:
measure: Salivary pH
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
measure: Saliva carbonic anhydrase concentration
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
measure: Saliva total protein concentration
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
measure: Saliva mucin 5B concentration Saliva mucin 5B concentration
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
measure: Saliva mucin 7 concentration
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
measure: Taste perceptions
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day.
measure: Beverage liking
timeFrame: Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day
measure: Adverse Events
timeFrame: Symptoms reported at each test day and between visits from Screening to test day six
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Gatorade Sports Science Institute
state: New York
Study officials:
affiliation: PepsiCo, Inc. Sports Science
name: Lindsay Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: