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

NCT06933290 | Recruiting

• 1 other identifier: PEP-2423
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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)

Conditions

Taste Perception; Saliva Production

Keywords

taste; saliva; food pairing; salivary protein; mucin; salivary flow rate

Outcome Measures

Primary Outcomes (1)

• Salivary flow rate

  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 Outcomes (8)

• Salivary pH

  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

  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

  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

  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

  Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day

Study Arms (6)

Flavored carbonated drink 1

EXPERIMENTAL

Flavored carbonated beverage with nutritive sweeteners

Other: Beverage

Flavored carbonated drink 2

EXPERIMENTAL

Flavored carbonated beverage with non-nutritive sweeteners

Other: Beverage

Flavored drink

EXPERIMENTAL

Flavored non-carbonated beverage with nutritive sweeteners

Other: Beverage

Flavored non-carbonated drink

EXPERIMENTAL

Flavored non-carbonated beverage with non-nutritive sweeteners

Other: Beverage

Carbonated Water

EXPERIMENTAL

Unflavored carbonated water

Other: Beverage

Water

EXPERIMENTAL

Plain, unflavored, non-carbonated water

Other: Beverage

Interventions

Beverage OTHER

15 milliliter aliquot interspersed with tastants with a 3 minute break between tastants

Carbonated Water; Flavored carbonated drink 1; Flavored carbonated drink 2; Flavored drink; Flavored non-carbonated drink; Water

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Gatorade Sports Science Institute

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Medullary cystic kidney disease 1

Interventions

Beverages

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lindsay Baker, PhD

  PepsiCo, Inc. Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Baker, PhD

CONTACT

814-883-9454; Lindsay.Baker@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Partially blinded. Uncarbonated flavored drinks and water are distinguishable from carbonated flavored drinks and water.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 18, 2025
• Study Start: March 24, 2025
• Primary Completion: June 13, 2025
• Study Completion: June 29, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)