UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059663 |
|---|---|
| Receipt number | R000068228 |
| Scientific Title | Evaluation of Urinary Metabolites Following Intake of a Test Food in Women with Normal Menstrual Cycles: A Single-Arm Pre-Post Comparison Study |
| Date of disclosure of the study information | 2025/11/06 |
| Last modified on | 2025/11/06 11:15:27 |
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Basic information
Public title
Evaluation of Urinary Metabolites Following Intake of a Test Food in Women with Normal Menstrual Cycles: A Single-Arm Pre-Post Comparison Study
Acronym
Evaluation of Urinary Metabolites Following Intake of a Test Food in Women with Normal Menstrual Cycles: A Single-Arm Pre-Post Comparison Study
Scientific Title
Evaluation of Urinary Metabolites Following Intake of a Test Food in Women with Normal Menstrual Cycles: A Single-Arm Pre-Post Comparison Study
Scientific Title:Acronym
Evaluation of Urinary Metabolites Following Intake of a Test Food in Women with Normal Menstrual Cycles: A Single-Arm Pre-Post Comparison Study
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of an analytical method for urinary metabolites following consumption of the test food
Basic objectives2
Others
Basic objectives -Others
Establishment of an analytical method for urinary metabolites following consumption of the test food
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in urinary metabolites pre- and post-intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
8-day intake of test food
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Japanese women residing in Japan who are between the ages of 18 and 40 at the time of obtaining consent to participate in the trial.
(2)Individuals with a normal menstrual cycle (the last three menstrual cycles were between 25 and 38 days, and the duration of menstruation was between 3 and 7 days).
(3)Individuals who can cooperate in consuming the test food daily during the intake period.
(4)Individuals who have received sufficient explanation about the purpose and content of this study, possess the capacity to consent, can fully understand the content, and can provide written informed consent.
Key exclusion criteria
(1) Regular use of oral contraceptives, ovulation inhibitors, hormonal drugs, or medicines/Kampo for menstrual symptoms (except temporary use of OTC analgesics for menstrual pain or headache, or laxatives/antidiarrheals around menstruation).
(2) Under treatment for PMS, PMDD, dysmenorrhea, or other gynecological diseases (e.g., menopausal disorder, hormone therapy, uterine/ovarian/breast disease), or scheduled for such treatment during the study.
(3) Under treatment for thyroid disease, autonomic disorders, psychiatric disorders (e.g., depression, anxiety, insomnia, panic disorder), diabetes, or hyperlipidemia, or scheduled for such treatment.
(4) Under treatment for chronic diseases (e.g., anemia, perennial allergy, asthma, hypertension).
(5) History of cerebrovascular, cardiac, hepatic, or renal disease.
(6) History of major gastrointestinal surgery (e.g., gastrectomy, intestinal resection; appendectomy not excluded).
(7) Allergy to the test food.
(8) Pregnant, lactating, possibly pregnant, or planning pregnancy.
(9) Regular use of FOSHU, Foods with Function Claims, health foods, or supplements with specific ingredients.
(10) Unable to discontinue such foods or supplements during the study.
(11) Unwilling to restrict intake of general foods high in specific ingredients during the study.
(12) Heavy smokers (about 21+ cigarettes/day).
(13) Habitual alcohol intake >=20 g/day (approx. 180 mL sake, 500 mL beer, 110 mL shochu, or 200 mL wine).
(14) Extremely irregular sleep or diet (e.g., shift/night workers).
(15) Regular use of antibiotics during the study.
(16) Expected major changes in living environment, diet, or exercise during the study.
(17) Judged by the investigator as inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawabata |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
06-6477-8352
hiroshi.kawabata@glico.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hara |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
06-6477-8352
Homepage URL
yoshihiro.hara@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
Tel
06-6477-8352
kazunori.nishi@glico.com
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
| 2025 | Year | 11 | Month | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068228
