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Strawberry Gummies for Oral Health

Phase 1

Waitlist Available

Led By Yael Vodovotz, PhD.

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Abstain from the use of ANY mouth washes (commercial or home remedies) during 6 week study period

- Non-smoker: Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL)

Must not have

Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth)

Have significant loss of gastrointestinal organs due to surgery, except for appendix

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, 7, 21, 28

Summary

This trial is testing if eating strawberry gummies has an effect on oral health. The researchers will measure inflammation hormones, genes in the mouth and blood, and compare two types of strawberry gummies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects were not explicitly listed but may include allergic reactions to ingredients like strawberries, corn or wheat products. As this is a food-based intervention rather than medication, fewer side effects are expected compared to pharmaceutical trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will not use any mouthwash for 6 weeks.

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I do not smoke or use tobacco products and my urine test for nicotine is negative.

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I agree to follow a specific vitamin and mineral plan and not take other supplements during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a condition affecting my metabolism or digestion, like Crohn's or thyroid issues.

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I take hormone supplements due to a pituitary or other hormone-related condition.

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I need dental treatment during the study.

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I have open sores or oral issues that haven't healed in over 3 months.

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I am taking blood thinners or using prescribed mouthwash.

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I have not taken antibiotics or medications affecting bowel movements in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies.

Secondary study objectives

Measure salivary inflammatory markers and gene expression profiles in oral mucosa that promote oral health following short-term exposure to strawberry fruit polyphenol.

Quantify the enteral absorption and excretion patterns of strawberry polyphenols in smoking and non-smoking healthy adult men and women consuming the strawberry and placebo gummies.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Strawberry gummyActive Control1 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 gummyPlacebo Group1 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).

0 / 11Eligibility criteria met