UMIN-CTR Clinical Trial

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.
Region	Japan

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

Objectives
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

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

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	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.
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 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
Last 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
Email	sunaga@nittai.ac.jp

Public contact
1st 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
Email	makoto.yamaguchi@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

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
Address
Tel
Email

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	2018 Year 06 Month 08 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	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
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037099