Healthy female adults
Conditions
Interventions
Ingestion of the test food without chewing, before or after breakfast, one tablet a day.
Ingestion of the placebo food without chewing, before or after breakfast, one tablet a day.
Sponsors
CPCC Company Limited
Chiyoda Oralhealth Care Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Female subjects aged 50 to 65 years old when consent acquisition. (2) Postmenopausal subjects. (3) Subjects with resting salivary secretion of more than 1.5 g. (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who routinely use the health-specific/functional/supplementary/health foods which may affect this study (more than three times a week), and have any difficulty in stopping use after the consent. (2) Subjects who have used medicines which may affect this study, more than two days a week, and have any difficulty in limiting use during this study. (3) Subjects who are planning to visit the hospital for cavity protection or oral cleaning during this study. (4) Subjects who have been determined as dry mouth symptom and/or Sjogren's syndrome. (5) Subjects with smoking habit, now and/or within a year before this study. (6) Subjects who drink a lot of alcohol. (7) Subjects having some kind of serious/progressive disease and symptom. (8) Subjects with previous/present medical history of serious diseases in heart, liver, kidney and digestive organs. (9) Subjects with some kind of drug and/or food allergy. (10) Subjects who are now under another clinical study with a medicine/food, or took part in that within 4 weeks before this study, or will join that after giving informed consent to join this study. (11) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this study. (12) Subjects who donated over 400 mL of their whole blood within the last 4 months before this study. (13) Subjects who will be collected over 800 mL in total of their blood within 12 months, before and in this study. (14) Subjects who have been determined as ineligible for participation, by the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary secretion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comprehensive analysis of oral microbiome, and the number of oral bacteria 2. Salivary IgA, amylase, chromogranin A, cortisol, lactoferrin, lysozyme 3. Halitosis analysis 4. VAS 5. Short version of POMS2 6. OSA sleep inventory MA version 7. Pittsburg sleep questionnaire 8. NAD-metabolites in blood | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed