The effects of milk components intake on symptoms associated with menstruation.

Not Applicable

• Conditions: Healthy subjects

• Registration Number: JPRN-UMIN000032530
• Lead Sponsor: Meiji Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-08
• Study Completion: 2019-02-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified