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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests strawberry gummies to determine their impact on oral health, particularly in smokers and non-smokers. Researchers aim to understand how the mouth absorbs these gummies and whether they can reduce inflammation, which is linked to gum disease and oral cancer. Participants will try two types of gummies: one with real strawberries (strawberry gummy) and one without (placebo control gummy), to compare their effects. Individuals who smoke at least 10 cigarettes a day or have never smoked might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that strawberries contain natural compounds called polyphenols, which might help lower the risk of gum disease. The strawberry gummies in this study are made with freeze-dried strawberries and might contain these beneficial compounds as well.

Specific safety information for these strawberry gummies is not yet available, but similar products, such as sugar-free chewing gum, are generally safe. The gummies are made with common food ingredients like corn syrup and wheat starch, which most people can consume without issues.

This trial is in an early stage, focusing mainly on safety. If the gummies are similar to other strawberry products, they should be safe for most people. However, participants should watch for any reactions and inform the study team if anything unusual occurs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about strawberry gummies for oral health because they offer a unique, natural approach to maintaining oral hygiene. Unlike traditional treatments like fluoride toothpaste or mouthwash, these gummies are made with 45% freeze-dried strawberries, potentially harnessing the natural benefits of fruit to improve oral health. This innovative use of a food-based product could provide an accessible and enjoyable way for people to support their oral health, making it particularly appealing for those who prefer natural ingredients over chemical-based options. Additionally, consuming these gummies may encourage better oral health practices, especially among those who might not consistently use conventional oral care products.

What evidence suggests that the strawberry gummies could be effective for oral health?

Research shows that strawberries contain natural chemicals called polyphenols, which might help lower the risk of gum disease. These chemicals are linked to better oral health because they may reduce swelling in the mouth. Studies are examining how strawberries might affect genes related to mouth cancer, especially in smokers. Early results suggest that eating strawberries could benefit mouth tissues and help fight mouth cancer. In this trial, participants will receive either a strawberry gummy or a placebo gummy. The strawberry gummies contain more antioxidants than regular candies, which might further support oral health. ^{2 6 7 8 9}

Who Is on the Research Team?

Yael Vodovotz, PhD.

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3312213/

Effects of Chewing Different Flavored Gums on Salivary ... In the 1st minute, the strawberry-flavored gums showed the highest SFR. During 1–3 minutes, strawberry- and apple-flavored gums showed higher SFR, respectively.

2. clinicaltrial.be clinicaltrial.be/nl/details/12825?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

The Use of Functional Confections in Promoting Oral Healt... Polyphenols (plant chemicals, some produce purple and red color in fruits) found in strawberries have been associated with reducing the risk of gum disease.

3. dental-tribune.com dental-tribune.com/news/new-research-explores-effect-of-strawberries-in-oral-cancer-therapy/

New research explores effect of strawberries in oral cancer ... Studies are also ongoing to identify strawberry-modulated genes in the oral cavities of smokers that may influence the development of oral cancer. advertisement.

4. cancer.osu.edu cancer.osu.edu/news/new-research-investigates-strawberries-to-fight-oral-cancer-in-heavy-smokers

New Research Investigates Strawberries to Fight Oral Cancer ... The combination effect of smoking/strawberry exposure on oral cancer risk and its relation to gene expression remains unclear, and is currently ...

5. degruyterbrill.com degruyterbrill.com/document/doi/10.1515/opag-2021-0029/html?lang=en&srsltid=AfmBOooSKh8tnaL0ILJuu_HZnu6cR6Zl0UFWJauKE-X3TkOKXGHEUxDj

Development and characterization of healthy gummy jellies ... In addition, the developed gummies showed lower caloric values and higher antioxidant capacity than similar commercial candies. Overall, ORH and BEM gummy ...

6. withpower.com withpower.com/trial/phase-1-mouth-neoplasms-10-2010-226f9

Strawberry Gummies for Oral Health · Info for Participants The research does not provide specific safety data for strawberry gummies, but it discusses the safety of sugar-free chewing gums, which are generally ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9102268/

Berry By-Products in Combination with Antimicrobial Lactic ... The purpose of this research was to develop formulations of chewing candies (CCs) in a sustainable manner by using berry by-products in ...

8. researchgate.net researchgate.net/publication/276836204_Evaluation_of_aroma_release_of_gummy_candies_added_with_strawberry_flavours_by_gas-chromatographymass-spectrometry_and_gas_sensors_arrays

Evaluation of aroma release of gummy candies added with ... Evaluation of aroma release of gummy candies added with strawberry flavours by gas-chromatography/mass-spectrometry and gas sensors arrays.

9. fda.gov.ph fda.gov.ph/fda-advisory-no-2023-1208-public-health-warning-against-the-purchase-and-consumption-of-the-unregistered-food-product-lodys-strawberry-gummy/

FDA Advisory No.2023-1208 || Public Health Warning ... The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the unregistered food product.