Flavored, Carbonated Drinks for Dry Mouth

Overseen By Lindsay Baker, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: PepsiCo Global R&D

Disqualifiers: Nicotine use, Recent illness, Oral conditions, Dysgeusia, Parosmia, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

13 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking medication that the investigator believes might interfere with the study, you may not be eligible to participate.

What data supports the effectiveness of the treatment Flavored, Carbonated Drinks for dry mouth?

Research shows that flavored sugarless gum and sorbitol-sweetened breath mints can increase salivary flow in people with dry mouth. This suggests that flavored, carbonated drinks might also help by stimulating saliva production. ^{1 2 3 4 5}

Is it safe to consume flavored, carbonated drinks for dry mouth?

Flavored carbonated drinks, like other soft drinks, can cause dental enamel erosion, especially if they contain sugar or artificial sweeteners. However, food flavorings used in these drinks are generally considered safe at low levels, as they undergo safety evaluations by organizations like the FAO and WHO. ^{6 7 8 9 10}

How do flavored, carbonated drinks for dry mouth differ from other treatments?

Flavored, carbonated drinks for dry mouth are unique because they provide a refreshing and enjoyable way to stimulate saliva production, unlike traditional saliva substitutes that may come in spray form. These drinks may also incorporate elements like carbonation and flavoring, which can enhance the sensory experience and potentially improve compliance compared to other treatments. ^{6 7 11 12 13}

What is the purpose of this trial?

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)

Research Team

Lindsay Baker, PhD

Principal Investigator

PepsiCo, Inc. Sports Science

Eligibility Criteria

This trial is for individuals interested in how flavored, carbonated drinks affect saliva and taste. Specific eligibility criteria are not provided, so it's assumed that participants should be generally healthy with an interest in the study's focus.

Inclusion Criteria

Subject is willing to fast (no food or gum) for 2 hours prior to study sessions

Able to speak, write, and read English

Subject is a regular consumer of carbonated drinks (questionnaire)

Exclusion Criteria

Subject has participated in a clinical trial within the past 30 days

Subject smokes, vapes, or uses any nicotine/tobacco products (or has quit for less than 6 months)

Subject has participated in any PepsiCo trial within past 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Test Sessions

Participants undergo test sessions with different beverages to measure salivary flow rate, composition, and taste perceptions

6 sessions over 2-8 days apart

6 visits (in-person)

Follow-up

Participants are monitored for adverse events and overall safety

2 weeks

Treatment Details

Interventions

• Flavored, Carbonated Drinks

Trial Overview The study investigates the impact of various beverages on salivary flow rate, saliva composition, and taste perceptions. Participants will compare flavored carbonated drinks to control drinks like water and non-carbonated options.

Participant Groups

Group I: Water Experimental Treatment 1 Intervention

Plain, unflavored, non-carbonated water

Group II: Flavored non-carbonated drink Experimental Treatment 1 Intervention

Flavored non-carbonated beverage with non-nutritive sweeteners

Group III: Flavored drink Experimental Treatment 1 Intervention

Flavored non-carbonated beverage with nutritive sweeteners

Group IV: Flavored carbonated drink 2 Experimental Treatment 1 Intervention

Flavored carbonated beverage with non-nutritive sweeteners

Group V: Flavored carbonated drink 1 Experimental Treatment 1 Intervention

Flavored carbonated beverage with nutritive sweeteners

Group VI: Carbonated Water Experimental Treatment 1 Intervention

Unflavored carbonated water

Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials

99

Recruited

13,600+

Ramon Laguarta

PepsiCo Global R&D

Chief Executive Officer since 2018

MBA from ESADE Business School

Mark Kirkham

PepsiCo Global R&D

Chief Marketing Officer

Bachelor's degree in Business Administration from Trinity College Dublin

References

1. United States pubmed.ncbi.nlm.nih.gov

Interaction of saliva and taste. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of chewing sorbitol-sweetened gum on salivary flow and cemental plaque pH in subjects with low salivary flow. [2018]

3. India pubmed.ncbi.nlm.nih.gov

Effects of milk curd on saliva secretion in healthy volunteer compared to baseline, 2% pilocarpine and equivalent pH adjusted acetic acid solutions. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of sorbitol sweetened breath mints on salivary flow and plaque pH in xerostomic subjects. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Towards tooth friendly soft drinks. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Caffeinated Soft Drinks on Salivary Flow. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of sports drinks and other beverages on dental enamel. [2005]

9. United States pubmed.ncbi.nlm.nih.gov

Review of published cases of adverse cardiovascular events after ingestion of energy drinks. [2014]

10. Ireland pubmed.ncbi.nlm.nih.gov

Safety evaluation of food flavorings. [2005]

11. Spain pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new artificial saliva in spray form for patients with dry mouth. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Effect on plaque pH of fruit drinks with reduced carbohydrate content. [2019]

13. India pubmed.ncbi.nlm.nih.gov

Evaluation of the cariogenicity of sugar containing drinks by estimating changes in pH of human dental plaque and saliva. [2022]