UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055745 |
|---|---|
| Receipt number | R000063703 |
| Scientific Title | A Study to Investigate the Effect of Food Ingredient Intake on Saliva Secretion |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/04/07 09:14:03 |
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Basic information
Public title
A Study to Investigate the Effect of Food Ingredient Intake on Saliva Secretion
Acronym
A Study to Investigate the Effect of Food Ingredient Intake on Saliva Secretion
Scientific Title
A Study to Investigate the Effect of Food Ingredient Intake on Saliva Secretion
Scientific Title:Acronym
A Study to Investigate the Effect of Food Ingredient Intake on Saliva Secretion
Region
| Japan |
Condition
Condition
Healthy Women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a test food on saliva secretion in healthy postmenopausal women over an 8-week period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change and change in values in stimulated saliva secretion.
Key secondary outcomes
- 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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral consumption of the test food (one tablet, twice daily after breakfast and dinner) for 8 weeks
Interventions/Control_2
Oral consumption of the placebo food (one tablet, twice daily after breakfast and dinner) for 8 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key 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.
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kitaoka |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5, Azahigashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga
TEL
0952-52-1522
kitaoka.ryo@otsuka.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
115
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063703
