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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032530
Receipt No. R000037099
Official scientific title of the study The effects of milk components intake on symptoms associated with menstruation.
Date of disclosure of the study information 2018/06/08
Last modified on 2018/06/08

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Basic information
Official scientific title of the study The effects of milk components intake on symptoms associated with menstruation.
Title of the study (Brief title) 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
Name of lead principal investigator Mikako Sunaga
Organization Nippon Sport Science University
Division name School of Childhood Sport Education
Address 7-1-1, Fukawsawa, Setagaya-ku, Tokyo
TEL 03-5706-1360
Email sunaga@nittai.ac.jp

Public contact
Name of contact person Makoto Yamaguchi
Organization Meiji Co., Ltd.
Division name Group 1, Health Science Research Department, Food Science & Technology Laboratories, R&D Division
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)

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

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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037099

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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