UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effectiveness of the milk component for menstrual symptoms
Acronym	A study of the effectiveness of the milk component for menstrual symptoms
Scientific Title	A study of the effectiveness of the milk component for menstrual symptoms
Scientific Title:Acronym	A study of the effectiveness of the milk component for menstrual symptoms
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to examine the effect on menstrual symptoms in continuous intake of milk components for 22 to 35 days coupled to menstrual cycle by performing the comparison with placebo group
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Total score of menstrual symptoms survey items
Key secondary outcomes	- Physical symptom score of menstrual symptoms survey items - Psychological symptoms score of menstrual symptoms survey items - VAS for menstrual pain

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1) Ingestion of study food substance: from 8th day of last menstruation started to 4th day of second menstruation started 2) Break period :from 5th day of second menstruation started to 7th day of third menstruation started 3) Ingestion of control food substance:from 8th day of third menstruation started to 4th day of fourth menstruation started
Interventions/Control_2	1) Ingestion of control food substance: from 8th day of last menstruation started to 4th day of second menstruation started 2) Break period :from 5th day of second menstruation started to 7th day of third menstruation started 3) Ingestion of study food substance:from 8th day of third menstruation started to 4th day of fourth menstruation started
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	25 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 are healthy female between 25 and 40 years old at the point of obtaining informed consent. 3) Subjects with 25 to 38 days menstrual cycle in the latest 6 menses and the menstrual duration is 3 to 7 days. 4) Subjects with menstrual symptoms from 3th day before menstruation strated to 3th day of menstruation strated.
Key exclusion criteria	1) Pregnant, lactating women or willing to be pregnancy during the study 2) Subjects who are willing to become pregnant during this study 3) Subjects who have histories of gynecologic disorder or have gynecologic disorder * Gynecologic disorder: Secondary amenorrhea, Dysmenorrhea, Endometriosis, Fibroid, Premenstrual dysphoric disorder (PMDD , Breast cancer, Cervical cancer, Uterine body cancer, Ovary cancer etc. 4) Subject with allergy to milk, wheat, egg, shrimp, crab, 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 classified as psychosomatic (Type IV) by CMI health questionnaire 8) Subjects with a score of 20 and above for the stress score by Brief Stress Level Check List 9) Subjects whose total score of menstrual symptoms survey items at the point of postmenstrual period is 1 or more points higher compared to the total score of the survey items before a menstrual period begins or during menstrual period in menstrual symptoms survey items (preliminary survey) 10) Subject who is ineligible for this study due to medical doctor's judgement
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Yamaguchi
Organization	Meiji Co., Ltd.
Division name	Group1, Health Science Research Department, Food Microbiology and Function Research Laboratories, R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	042-632-5849
Email	makoto.yamaguchi@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	153-0053
Address	Gohongi 3-13-16 Meguro-ku, Tokyo, Japan
TEL	080-7290-0404
Homepage URL
Email	imai@levbrain.com

Sponsor
Institute	Leverage Brain Inc.
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	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
Tel	042-632-5900
Email	MEIJI.IRB@meiji.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）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 19 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	2019 Year 06 Month 19 Day
Date of IRB	2019 Year 06 Month 19 Day
Anticipated trial start date	2019 Year 07 Month 20 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 09 Day
Last modified on	2020 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042543