Healthy Women
Conditions
Interventions
Oral consumption of the test food (one tablet, twice daily after breakfast and dinner) for 8 weeks
Oral consumption of the placebo food (one tablet, twice daily after breakfast and dinner) for 8 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Subjects who are able to give informed consent to participate in this study. 2. Postmenopausal women aged 45 to below 65 years, with 2 to less than 5 years since their last menstrual period at the time of consent acquisition. 3. Subjects with symptoms associated with decreased saliva secretion. 4. Subjects with a stimulated saliva secretion rate of 2 g/2 min or more in the preliminary screening. 5. Subjects with a BMI between 18.5 and 30 kg/m2 in the preliminary screening. 6. Subjects who have not undergone hormone therapy or treatment with traditional Chinese medicine (e.g., Kampo) for menopausal symptoms within the 6 months prior to consent acquisition. 7. Subjects who can follow the schedule instructed by the research investigator, including test food consumption, participation in necessary tests, and answering questionnaires.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of or current diagnosis of breast cancer, benign breast tumors, endometrial cancer, cervical cancer, ovarian cancer, or similar conditions. 2. Subjects with allergies to soy. 3. Subjects undergoing pharmacological treatment for any chronic disease. 4. Subjects with serum estradiol levels exceeding 21 pg/ml in the preliminary screening. 5. Subjects who have consumed supplements or health foods within 3 months prior to the start of the study. 6. Subjects who cannot agree to refrain from consuming OTC medications, health foods, or dietary supplements (including Foods for Specified Health Uses, Foods with Function Claims, supplements, and energy drinks) other than the test food during the study period (with the exception of occasional use of OTC medications containing herbal medicines). 7. Subjects with a smoking habit. 8. Subjects who may require medication for hay fever between January and April. 9. Subjects who cannot agree to refrain from using artificial saliva (e.g., Salivart), mouthwash containing moisturizers, moisturizing spray, or moisturizing gel during the study period. 10. Subjects scheduled for dental procedures (e.g., extractions, implants) that may affect chewing or saliva secretion during the study period. 11. Subjects scheduled for dental treatment within the week prior to each clinic visit. 12. Subjects testing positive for HBs antigen, HCV antibodies, HIV antigen/antibodies, or syphilis serological tests. 13. Other Subjects deemed unsuitable by the principal investigator or study director based on clinical test results or other considerations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change and change in values in stimulated saliva secretion. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Rate of change and change in values in resting saliva secretion. - Rate of change and change in values in oral symptoms VAS (Visual Analogue Scale). - Rate of change, change in values, and improvement rate in oral symptom questionnaire. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed