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Recruitment status Completed
Unique ID issued by UMIN UMIN000032530
Receipt No. R000037099
Scientific Title The effects of milk components intake on symptoms associated with menstruation.
Date of disclosure of the study information 2018/06/08
Last modified on 2019/04/01

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Basic information
Public title The effects of milk components intake on symptoms associated with menstruation.
Acronym The effects of milk components intake on symptoms associated with menstruation.
Scientific Title The effects of milk components intake on symptoms associated with menstruation.
Scientific Title:Acronym The effects of milk components intake on symptoms associated with menstruation.

Condition Healthy subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Narrative objectives1 To examine the effectiveness against symptoms associated with menstruation of milk components in placebo-controlled.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Primary outcomes Total score of the menstrual distress questionnaire (MDQ) at premenstruation and inter menstruation during intake of milk components.
Key secondary outcomes

Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Dynamic allocation
Institution consideration

No. of arms 2
Purpose of intervention Prevention
Type of intervention
Interventions/Control_1 The subjects intake the milk components, once daily during two menstrual cycles.
Interventions/Control_2 The subjects intake placebo, once daily during two menstrual cycles.

Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria 1)Subjects who received adequate explanation of the purpose and contents of this clinical trial volunteered with sufficient consent, voluntarily volunteered with voluntary understanding, agreed to participate in the document.
2)Subjects who do not wish to become pregnant during this study period.
3)Subjects who are healthy adult females aged 20 to 40 at the time of obtaining informed consent, and who satisfy the following conditions at screening.
a)Menstrual cycle is between 25 to 38 days.
b)Menstruation period is between 3 to 7 days.
c)A subject who is aware of menstrual pain and who responded that the pain is controllable with commercially available NSAIDs.
d)A subject who is aware of symptoms like premenstrual syndrome.
e)A subject who applicable to the areas I to III in the neurotic discrimination diagram of the Cornell Medical Index (CMI) questionnaire result.
f)A subject who applicable within the range of stress level less than 20 (mild and moderate stress) as a result of simple stress level check.
g)A subject whose fill out of MDQ and living situation questionnaires is 70% or more in the period of the first menstrual cycle after acquiring informed consent.
Key exclusion criteria 1)Pregnant women, lactating women or those who may be pregnant.
2)Secondary amenorrhea whose menstruation had been stopped for at least 3 months.
3)A subject who has history of gynecology such as dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), breast cancer, cervical cancer, uterine body cancer, ovarian cancer etc.
4)A subject who received the administration of the following medicinal products within 2 months before acquisition.
a)Hormone preparations based on luteinizing hormone or follicle hormone
b)gonadotropin-releasing hormone(GnRH) analog preparation, testosterone derivative
c)Chinese medicine having indication for dysmenorrhea or automatic imbalance.
d)Mood disorder (depression, bipolar disorder, dysthymia disorder), anxiety disorder (adaptive disorder, social anxiety disorder, panic disorder, obsessive compulsive disorder), developmental disorder (autism spectrum disorder, attention deficit/hyperactivity Drugs with indications for either sleep disorders (ADHD), sleep disorders
5)A subject who regularly used the following medicines etc. from 2 months ago to consent acquisition until now.
(regularly in this study refers to taking or ingesting consecutively over a week or more)
a)Any of herbal medicines, Keishi Shikuryo Maru, Ajisen Hakuza, Shikanedakuyaku
b)Commercial gynecological Chinese medicine preparation
c)Commercially available sleep-improving drugs
d)Nutraceuticals based on isoflavones
6)A subject who has regularly used medicines, quasi-drugs, supplements, health foods that may affect this clinical trial within 2 months before informed consent acquisition.
7)A subject who has milk, wheat, egg, shrimp or crab allergy, or lactose intolerance.
8)A subject who participated in other clinical and monitoring trials during the two months before consent acquisition.
9)A subject who is judged inappropriate as subjects by the the principal investigator or the doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikako Sunaga
Organization Nippon Sport Science University
Division name School of Childhood Sport Education
Zip code
Address 7-1-1, Fukawsawa, Setagaya-ku, Tokyo
TEL 03-5706-1360

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Yamaguchi
Organization Meiji Co., Ltd.
Division name Group 1, Health Science Research Department, Food Science & Technology Laboratories, R&D Division
Zip code
Address 1-29-1, Nanakuni, Hachiouji, Tokyo
TEL 042-632-5849
Homepage URL

Institute Meiji Co., Ltd.

Funding Source
Organization Meiji Co., Ltd.
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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

Recruitment status Completed
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
2018 Year 04 Month 18 Day
Anticipated trial start date
2018 Year 06 Month 11 Day
Last follow-up date
2019 Year 02 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2019 Year 04 Month 01 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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