Male/female adults
Conditions
Interventions
Consumption of the test food (1 tablet a day) for 4 weeks
Consumption of the placebo food (1 tablet a day) for 4 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese men and women aged 25 to below 65 years at the time of consent acquisition. 2. Subjects with concerns about their oral environment. 3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly consume Food for Specified Health Uses (FOSHU) or Foods with Function Claims (including products containing reduced coenzyme Q10, Lactobacillus reuteri, and Gekkeiju leaf extract), or health supplements (including supplements), which might affect the oral environment, more than three times a week, and cannot discontinue them from the time of consent acquisition. 2. Subjects taking medications (such as antibiotics, antifungal drugs, antihistamines, antihypertensives) that may affect the trial, and cannot restrict their use from the time of consent acquisition. 3. Subjects using oral care products other than toothbrushes and toothpaste (such as mouthwash) and cannot restrict their use from the time of consent acquisition. 4. Subjects who regularly use toothpaste containing hydroxyapatite. 5. Subjects who have undergone dental treatment (including tartar cleaning and plaque cleaning) within three months prior to consent acquisition or are currently undergoing dental treatment. 6. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials. 7. Subjects using dental implants. 8. Subjects using partial dentures or bridges in two or more locations. 9. Subjects undergoing orthodontic treatment. 10. Subjects with excessive alcohol intake. 11. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 12. Females who are pregnant or lactating, and females who could become pregnant during trial period. 13. Subjects with allergies to medications and/or food.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depth of periodontal pockets | — |
Secondary
| Measure | Time frame |
|---|---|
| Saliva volume Presence of bleeding on probing Plaque index TCI (Tongue Coating Index) score Oral bacterial counts Subjective questionnaire | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed