UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055576 |
|---|---|
| Receipt number | R000063507 |
| Scientific Title | An Exploratory Study of the effectiveness of long-term consumption of the milk component on Menstrual Symptoms |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2025/12/24 11:23:41 |
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Basic information
Public title
An Exploratory Study of the effectiveness of long-term consumption of the milk component on Menstrual Symptoms
Acronym
An Exploratory Study of the effectiveness of long-term consumption of the milk component on Menstrual Symptoms
Scientific Title
An Exploratory Study of the effectiveness of long-term consumption of the milk component on Menstrual Symptoms
Scientific Title:Acronym
An Exploratory Study of the effectiveness of long-term consumption of the milk component on Menstrual Symptoms
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of long-term (3 menstrual cycles) continuous intake of alpha-lactalbumin (alpha-LA) on menstrual symptoms in healthy adult females with menstrual symptoms by comparing the effects with those of control food intake
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Distress Questionnaire
Key secondary outcomes
1)PMTS-VAS (Premenstrual Tension Syndrome-Visual Analog Scale)
2)Menstrual Symptoms VAS (Visual Analog Scale)
3)SF-36
4)Urinary Prostaglandins
5)Frequency of analgesics usage
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of study foods for 3 menstrual cycles
Interventions/Control_2
Consumption of control foods for 3 menstrual cycles
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) Subjects who received sufficient explanation of the purpose and contents of this study, have the ability to consent, volunteered of their own free will after fully understanding, and agreed to participate with a written document.
2)Healthy adult females whose age of 20 years or more and less than 40 years at the time of obtaining informed consent.
3)Subjects whose menstrual cycles are within the range of 25 to 38 days each, calculated from their menstrual history of six previous cycles, and whose usual menstrual duration is 3 to 7 days.
4) Subjects who are aware of any menstrual symptoms from 3 days before the start of menstruation to the third day of menstruation.
Key exclusion criteria
1) Subjects who are pregnant, lactating, or possibly pregnant
2) Subjects who wish to become pregnant during the study period
3) Subjects who have histories of gynecologic disorder* or have gynecologic disorder
* Secondary Amenorrhea, Dysmenorrhea, Endometriosis, Uterine Fibroids, Premenstrual Dysphoric Disorder (PMDD), Breast Cancer, Cervical Cancer, Uterine Body Cancer, Ovarian Cancer, etc.
4) Subject with allergy to milk, wheat,egg, shrimp, crab, peanuts, walnuts, or subjects with lactose intolerance
5) Subjects who had participated in other clinical trials or monitoring studies within 2 month prior to obtaining informed consent
6) Subjects without menstruation pain, or subjects with severe menstruation pain and unable to control the pain by taking over-the-counter analgesic medication
7) Subjects who take regularly pharmaceuticals (including Chinese medicine and pill) or supplements which have the possibility to affect the results of the present study from 2 months before the time of informed consent to the day of informed consent
8) Subjects with a history or present illness of a mood disorder or a score of 60 or higher on the Self-Rating Depression Scale (SDS).
9) Subjects classified as psychosomatic (Type IV) by the CMI health questionnaire
10) Subjects with a score of 20 and above for the stress score on the Brief Stress Level Check List
11) Subjects whose total score of menstrual symptoms survey items (Screening test) at the point of postmenstrual period is higher by 1 point or more compared to the total score of the survey items before a menstrual period begins or during menstrual period in menstrual symptoms survey items
12) Subject who is ineligible for this study due to medical doctor's
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Meiji Co., Ltd.
Division name
Nutrition and Food Function Group Health Science Research Unit. R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
042-632-5847
kentarou.itou@meiji.com
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
150-0002
Address
Shibuya 1-4-7 Shibuya-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Japan Conference of Clinical Research
Address
3-4-7 toranomon Minakto-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.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
茅場町こころのケアクリニック（東京都）
Kayaba-cho Mental Health Care Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 06 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063507
