UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060477 |
|---|---|
| Receipt number | R000069180 |
| Scientific Title | Exploratory Secondary Analysis of the Efficacy of Test Foods in Improving Menstrual Symptoms |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/26 17:30:05 |
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Basic information
Public title
Exploratory Secondary Analysis of the Efficacy of Test Foods in Improving Menstrual Symptoms
Acronym
Exploratory Secondary Analysis of the Efficacy of Test Foods in Improving Menstrual Symptoms
Scientific Title
Exploratory Secondary Analysis of the Efficacy of Test Foods in Improving Menstrual Symptoms
Scientific Title:Acronym
Exploratory Secondary Analysis of the Efficacy of Test Foods in Improving Menstrual Symptoms
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An exploratory secondary analysis using data from a previously conducted trial (UMIN000055337) aims to identify factors influencing the efficacy of the test food in improving menstrual-related symptoms in women aged 25 to 40 with normal menstrual cycles who experience such symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploration of Factors Influencing Improvement Effects Based on PMTS-VAS Evaluation
Key secondary outcomes
Exploratory Evaluation of the Following Items
PAF short version (subscale scores)
PMTS-VAS
POMS 2 adult short version
Original VAS
OSA sleep inventory MA version
WPAI
Salivary Estradiol and Salivary Progesterone
Stool frequency and shape
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Since participants were selected from those who had already enrolled in the existing randomized double-blind parallel-group trial (UMIN000055337), no new key inclusion criteria were established.
Key exclusion criteria
Since participants were selected from those who had already enrolled in the existing randomized double-blind parallel-group trial (UMIN000055337), no new key exclusion criteria were established.
Target sample size
464
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 | Nanae |
| Middle name | |
| Last name | Onishi |
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
nanae.onishi@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
| 2026 | Year | 01 | Month | 27 | 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
| 2026 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a secondary analysis using data obtained from a previously conducted trial (UMIN000055337). The objective is to explore factors that may influence the effect of the test food on improving menstrual-related symptoms among women aged 25-40 years with regular menstrual cycles and menstrual-related symptoms. No new intervention, invasion, or observation will be conducted in this study.
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069180
