UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060040 |
|---|---|
| Receipt number | R000068660 |
| Scientific Title | Evaluation of the Effect of Test Food Consumption on Premenstrual Symptoms (Exploratory Study) : A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Study |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2025/12/10 17:45:10 |
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Basic information
Public title
Evaluation of the Effect of Test Food Consumption on Premenstrual Symptoms
Acronym
Evaluation of the Effect of Test Food Consumption on Premenstrual Symptoms
Scientific Title
Evaluation of the Effect of Test Food Consumption on Premenstrual Symptoms (Exploratory Study) : A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Study
Scientific Title:Acronym
Evaluation of the Effect of Test Food Consumption on Premenstrual Symptoms
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct an exploratory evaluation of the effects of consuming the test food on premenstrual symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Factor scale scores based on Mood Disorder Questionnaire (MDQ Japanese version) Form C (Negative Affect, Concentration, Behavioral Change scores, and the total score of these factors)
Key secondary outcomes
Factor scale scores based on MDQ Form C (Pain, Water Retention, Autonomic Dysregulation, Mood Elevation [Arousal], and Control scores, as well as the combined score of Pain, Water Retention, and Autonomic Dysregulation)
Each score of PMTS-VAS (12 items)
Each score of Shortened DRSP (8 items), subscale scores for psychological and physical symptoms, and the total score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
From day 5 of the first menstrual cycle (cycle 0) until 7 days after the end of the third menstrual cycle, participants will take the test food (two capsules) once daily with water.
Interventions/Control_2
From day 5 of the first menstrual cycle (cycle 0) until 7 days after the end of the third menstrual cycle, participants will take the placebo food (two capsules) once daily with water.
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. Age between 20 years and under 40 years at the time of obtaining consent
2. Healthy Japanese women
3. Regular menstrual cycles and normal menstrual duration
(Reference ranges: menstrual cycle of 25-38 days and menstrual duration of 3-7 days)
4. Presence of subjective premenstrual symptoms
5. Individuals who have received sufficient explanation regarding the purpose and content of this study, have the capacity to consent, fully understand the information, voluntarily agree to participate, and provide their own consent through electronic informed consent
Key exclusion criteria
1. Individuals diagnosed with any disease or receiving treatment, preventive care, or medication (including herbal medicine), hormone replacement therapy, or scheduled to receive such treatment
2. Individuals with a history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disorders
3. Individuals with a history of severe gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection; appendectomy only allowed)
4. Individuals judged to have a possible mental disorder based on SDS scores in Web-SCR
5. Individuals with a low premenstrual score on MDQ Form C (excluding the mood elevation item) in the Web-SCR
6. Individuals with a history of discomfort or health deterioration due to blood sampling
7. Individuals with food allergies
8. Individuals who have donated 200 mL of whole blood within 4 weeks, component blood within 2 weeks, or 400 mL of whole blood within 16 weeks prior to the Web-SCR
9. Individuals with significant abnormalities in blood, urine, or physical examinations
10. Individuals unable to discontinue quasi-drugs, herbal medicines, foods for specified health uses, functional foods, health foods, or foods containing herbs, lactic acid bacteria, or bifidobacteria during the study
11. Current smoker
12. Individuals who habitually consume alcohol (approximately 60 g or more per day)
13. Individuals with extremely irregular sleep or eating habits (e.g., shift workers)
14. Individuals likely to experience major changes in living environment, diet, or exercise habits during the study
15. Individuals who are breastfeeding, pregnant, possibly pregnant, or intending to become pregnant during the study
16. Individuals currently participating in another clinical study, who participated within 4 weeks before Web-SCR, or who plan to participate during the study
17. Individuals judged unsuitable by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
g167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
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
kimoto@macromill.com
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Macromill, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KAGOME CO.,LTD. Research Ethics Review Committee
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
IRB@kagome.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
| 2026 | Year | 01 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 25 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068660
