UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032530 |
|---|---|
| Receipt number | 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 16:01:20 |
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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.
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
| 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
sunaga@nittai.ac.jp
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
makoto.yamaguchi@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037099
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