UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061175 |
|---|---|
| Receipt number | R000070001 |
| Scientific Title | Effect of continuous intake of the test food on premenstrual syndrome (PMS) symptoms |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/06 20:31:53 |
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Basic information
Public title
Effect of continuous intake of the test food on premenstrual syndrome (PMS) symptoms
Acronym
Effect of continuous intake of the test food on premenstrual syndrome (PMS) symptoms
Scientific Title
Effect of continuous intake of the test food on premenstrual syndrome (PMS) symptoms
Scientific Title:Acronym
Effect of continuous intake of the test food on premenstrual syndrome (PMS) symptoms
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reductive effects of continuous intake of the test food on premenstrual syndrome (PMS) symptoms in women with PMS through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Premenstrual Tension Syndrome - Visual Analog Scale
Key secondary outcomes
(1) Daily Records of Severity of Problems
(2) Profile of Mood States 2nd Edition
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
Take the test food for about 2 weeks.
Interventions/Control_2
Take the placebo food for about 2 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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Healthy females aged 20 to 39 years at the time of informed consent.
(2)Subjects with a normal menstrual cycle (25 to 38 days) and a normal menstrual period (3 to 7 days).
(3)Subjects with subjective symptoms of premenstrual syndrome (PMS).
(4)Subjects who have received a full explanation of the study's purpose and content, have the capacity to consent, and have voluntarily provided their own electronic informed consent (eIC) with a full understanding of the study.
Key exclusion criteria
(1) Subjects falling under any of the following categories:
a) Current heart, liver, or kidney disease (including complications of other diseases).
b) History of cardiovascular disease.
c) Current diagnosis of diabetes mellitus.
d) Allergies to the test food.
e) History of serious diseases such as cancer or tuberculosis.
f) History of mental illness.
(2) Subjects regularly using oral contraceptives (pill), ovulation inhibitors, hormone agents, medications for menstrual symptoms, or Chinese herbal medicine at the time of web screening (except for temporary use of OTC pain relievers for menstrual cramps or headaches only during premenstrual or menstrual periods).
(3) Subjects taking health foods related to PMS at the time of web screening.
(4) Subjects receiving medical treatment or medication for chronic diseases (gynecological, mental, thyroid, autonomic nervous system, or others) at web screening, or planning to do so during the study.
(5) Subjects who are pregnant (including possible pregnancy), breastfeeding, or planning to become pregnant during the study.
(6) Subjects diagnosed with PMDD by the investigator based on the PMDD assessment scale during web screening.
(7) Subjects unable to stop consuming FOSHU (Food for Specified Health Uses), Foods with Function Claims, or other health supplements.
(8) Subjects unable to stop consuming energy drinks.
(9) Current smokers.
(10) Subjects with an average daily alcohol intake exceeding 60g (pure alcohol equivalent).
(11) Subjects with extremely irregular dietary habits.
(12) Shift workers or night-shift workers.
(13) Subjects whose living environment, dietary habits, or exercise habits may significantly change during the study.
(14) Subjects currently participating in another study, or within 4 weeks of completing one, or planning to participate in another study during this period.
(15) Subjects otherwise deemed ineligible by the investigator or sub-investigator.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Matsuo |
Organization
Suntory Holdings Limited
Division name
Group Innovation Division Future Business Development Department
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL
050-1734-0891
Hideaki_Matsuo@suntory.co.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Ikeyama |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
umin@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Suntory Holdings Limited
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 Tsukiji Futaba Clinic
Address
1-9-9, Tsukiji, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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 | 04 | Month | 07 | 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 | 04 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070001
