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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, 7, 21, 28

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, 7, 21, and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, 7, 21, and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, 7, 21, and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 / 3Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

827 Previous Clinical Trials

502,715 Total Patients Enrolled

Yael Vodovotz, PhD.Principal InvestigatorOhio State University

Media Library

Strawberry gummy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01514552 — Phase 1

Oral Hygiene Research Study Groups: Strawberry gummy, Placebo gummy

Oral Hygiene Clinical Trial 2023: Strawberry gummy Highlights & Side Effects. Trial Name: NCT01514552 — Phase 1

Strawberry gummy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01514552 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met to partake in this research?

"Candidates will be evaluated on their oral health and age, which must fall between 18 and 70. The medical trial is expecting to accept approximately 36 individuals in total."

Answered by AI

Is this trial accessible to individuals who have reached the age of majority?

"This clinical trial is open to applicants 18-70 years old. Additionally, there are 7 trials specifically designed for those younger than 18 and 75 studies available for seniors above 65."

Answered by AI