Strawberry Gummies for Oral Health

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University

Must not be taking: Antibiotics, Clotting inhibitors, Oral rinses

Disqualifiers: Allergies, Metabolic disorders, Autoimmune, Cancer, Alcohol, others

Compensation: Varies

Number of Visits: 6

Duration: 1 week

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to avoid nutritional, dietary, or alternative medications/supplements and certain medications like those that inhibit clotting (e.g., warfarin) or prescribed oral rinses during the study. If you are on these, you may need to stop them, but the protocol does not specify other medications.

What data supports the effectiveness of the strawberry gummy treatment for oral health?

The review on chewing gum suggests that products with sugar substitutes can be beneficial for oral health by not lowering plaque pH to harmful levels, which may imply that similar sugar-free gummy products, like strawberry gummies, could also support oral health. ^{1 2 3 4 5}

Is there any safety information available for strawberry gummies used for oral health?

The research does not provide specific safety data for strawberry gummies, but it discusses the safety of sugar-free chewing gums, which are generally considered safe for teeth if they do not lower plaque pH below 5.7. ^{5 6 7 8 9}

How is the strawberry gummy treatment unique for oral health?

The strawberry gummy treatment is unique because it uses strawberry extracts, which have been shown to have antimicrobial properties and potential dental bleaching effects, making it a novel approach compared to traditional oral health treatments. ^{3 5 10 11 12}

What is the purpose of this trial?

In areas of the world where populations are undernourished poor oral health is prevalent. Diets rich in fruit and vegetables are thought to have many health benefits including reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries contain many different compounds which may be responsible for these proposed health benefits. From this study, the researchers hope to gain information about how the tissues in the mouth absorb strawberry gummies in a population of habitually smoking and never smoking men and women. The researchers will measure inflammation hormones in your saliva and urine and the genes in your mouth and blood. Two different strawberry gummies will be tested in this study. The strawberry gummies were developed at OSU in the Department of Food Science and Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while the other type will have no fruit. In total the eight pieces of strawberry gummies that you will consume in one day will be at most equal to 1 cup of whole strawberries. The research team believes the two strawberry gummies may be digested and absorbed differently and that components in the strawberry gummies may be helpful for oral health.

Research Team

Yael Vodovotz, PhD.

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for men and women with a BMI of 20-35, who are either habitual smokers or have never smoked. Participants must avoid certain foods, supplements, and mouthwashes during the study. They cannot have gastrointestinal issues, altered immunity, heavy alcohol use, recent antibiotic use affecting bowel motility, dental treatment needs during the study period, swallowing difficulties or dry mouth conditions.

Inclusion Criteria

Meet one of the following smoking criteria:

Submit to a 24 hour urine cotinine test which will be used to determine smoking status

No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations

Exclusion Criteria

I have trouble swallowing or experience pain when swallowing, and I may have dry mouth or issues with my salivary glands.

I am a non-smoker or quit smoking less than 10 years ago.

I have had surgery that removed a significant part of my digestive organs, except for the appendix.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Dietary Adjustment

Participants start an anthocyanin-free diet to prepare for the study

2 weeks

1 visit (in-person)

Washout and Randomization

Participants undergo a washout period and are randomized into treatment groups

1 week

1 visit (in-person)

Treatment

Participants consume strawberry or placebo gummies and undergo pharmacokinetic studies

1 week

Daily consumption, 1 visit (in-person)

Crossover and Second Treatment

Participants switch to the alternate gummy type and repeat the treatment phase

1 week

Daily consumption, 1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Placebo control gummy
• Strawberry gummy

Trial Overview The trial tests two types of strawberry gummies: one with freeze-dried strawberries and another without fruit to see how they affect oral health in smokers and non-smokers. Researchers will examine saliva and urine for inflammation hormones and analyze genes in the mouth and blood after consumption.

Participant Groups

Group I: Strawberry gummy Active Control 1 Intervention

Each 6 gram strawberry gummy contains 45% freeze-dried fruit (California Strawberry Commission), 44% corn syrup (Karo, ACH Food Companies, Memphis, TN), 11% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL). With this formulation, daily fruit consumption is equivalent to 1 cup of whole strawberries. All ingredients (wheat starch, freeze-dried fruit, and high fructose corn syrup) will be purchased from a single lot. When a single lot is not available then the multiple manufacturing lots will be mixed into a single lot to be used for production of fruit gummies.

Group II: Placebo gummy Placebo Group 1 Intervention

Each 6 gram placebo gummy contains 79% corn syrup (Karo, ACH Food Companies, Memphis, TN), 20% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL), 1% artificial strawberry flavors (Kool-Aid Kraft Foods, East Hanover, NJ).

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

In a pilot study involving 8 nursing home residents, consuming herbal lollipops containing licorice root showed a trend toward reducing the levels of Streptococcus mutans, the bacteria responsible for dental caries.

Participants who consumed more lollipops over the 21-day period tended to have lower numbers of S. mutans, suggesting that larger studies could confirm the efficacy of this herbal intervention in improving oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a licorice lollipop decrease cariogenic bacteria in nursing home residents? Mentes, JC., Kang, S., Spackman, S., et al.[2012]

In a study involving 62 post-radiotherapy head and neck cancer patients, both an edible saliva substitute (oral moisturizing jelly, OMJ) and a topical saliva gel (GC) significantly improved dry mouth symptoms and swallowing ability over 2 months.

The OMJ was found to be more effective than the GC in alleviating dry mouth and swallowing problems, which in turn positively impacted the patients' clinical nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. Nuchit, S., Lam-Ubol, A., Paemuang, W., et al.[2022]

References

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

Can a licorice lollipop decrease cariogenic bacteria in nursing home residents? [2012]

2. England pubmed.ncbi.nlm.nih.gov

Compatibility of two types of gummy jelly tests for detecting decreased masticatory function. [2022]

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

Comparative clinical evaluation of a local drug delivery of cranberry and garcinia fruit gel with tetracycline fibers for amelioration of periodontitis: A split mouth study. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. [2022]

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

Chewing gum--facts and fiction: a review of gum-chewing and oral health. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Food acid content and erosive potential of sugar-free confections. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Chewing gum intake in Europe: a survey of intakes in France, Germany, Italy, Spain and the UK. [2015]

8. Japan pubmed.ncbi.nlm.nih.gov

The inhibitory effect of funoran and eucalyptus extract-containing chewing gum on plaque formation. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Are paediatric medicines risk factors for dental caries and dental erosion? [2022]

10. England pubmed.ncbi.nlm.nih.gov

Potential benefits of chewing gum for the delivery of oral therapeutics and its possible role in oral healthcare. [2018]

11. England pubmed.ncbi.nlm.nih.gov

The effect of sugar-free chewing gum on plaque and clinical parameters of gingival inflammation: a systematic review. [2018]

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

In-vitro evaluation of the effectiveness of polyphenols based strawberry extracts for dental bleaching. [2023]