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Study on the intervention of research food components on the oral environment in adult male and female subjects

Study on the intervention of agarooligosaccharides on the oral environment in adult male and female subjects - Study on the intervention of agarooligosaccharides on the oral environment in adult male and female subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057380
Enrollment
20
Registered
2025-03-24
Start date
2024-11-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Mouth-rinsing using research-food-component-non-containing-mouthrinse. Mouth-rinsing using research-food-component-cointaining-mouthrinse. Mouth-rinsing using research-food-component-cointaining-mouth

Sponsors

Ina Food Industry Co., Ltd.
Lead Sponsor
Fujita Health University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Individuals aged 18 to under 70. (2) Individuals who do not have any oral, dental, or gum diseases (not diagnosed with periodontitis or periodontal disease) and are concerned about their oral condition but do not require immediate treatment. (3) Individuals who fully understand the purpose and content of the study and voluntarily consent to participate in the research.

Exclusion criteria

Exclusion criteria: (1) Individuals diagnosed with oral diseases including periodontitis and other periodontal diseases, and those who are scheduled for dental treatment on the day of implementation. (2) Individuals who regularly consume (three or more times a week) products containing oligosaccharides such as agarooligosaccharides, or have done so within the three months prior to the pre-test. (3) Individuals diagnosed with malignancies, or those undergoing treatment for neurological disorders, heart disease, kidney disease, diabetes, thyroid dysfunction, or those with a history of severe liver diseases. However, diseases deemed by the principal investigator to have no impact on this study's evaluation, such as treatment for hypertension, are excluded. (4) Individuals who consume large amounts of alcohol (equivalent to 60 g of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 go [about 540 mL] of sake, or 180 mL of whiskey). (5) Individuals who are at risk of developing allergies related to the study products. (6) Individuals judged to be unsuitable as subjects based on responses to the lifestyle questionnaire. (7) Individuals who participated in another clinical study within one month prior to obtaining consent for this study, or those planning to participate in another clinical study after obtaining consent. (8) Other individuals deemed unsuitable as subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Changes in microbiota composition and diversity in the oral cavity between research-food-component-containing-mouthrinse intervention and placebo

Secondary

MeasureTime frame
Change in questionnaires responses between research-component-containing-mouthrinse intervention and placebo

Countries

Japan

Contacts

Public ContactKoji Karasawa

Ina Food Industry Co., Ltd. Research and Development Department, Development Division

k-kouji@kantenpp.co.jp0265781121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026