Healthy subjects
Conditions
Interventions
The subjects intake the milk components, once daily during two menstrual cycles.
The subjects intake placebo, once daily during two menstrual cycles.
Sponsors
Meiji Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of the menstrual distress questionnaire (MDQ) at premenstruation and inter menstruation during intake of milk components. | — |
Countries
Japan
Contacts
Public ContactMakoto Yamaguchi
Meiji Co., Ltd. Group 1, Health Science Research Department, Food Science & Technology Laboratories, R&D Division
Outcome results
None listed