An Exploratory Study of the effectiveness of long-term consumption of the milk component on Menstrual Symptoms

UMIN ID: UMIN000055576

Registered date:27/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult female
• Date of first enrollment: 2024/10/01
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption of study foods for 3 menstrual cycles
Consumption of control foods for 3 menstrual cycles

Outcome(s)

• Primary Outcome: Menstrual Distress Questionnaire
• Secondary Outcome: 1)PMTS-VAS (Premenstrual Tension Syndrome-Visual Analog Scale) 2)Menstrual Symptoms VAS (Visual Analog Scale) 3)SF-36 4)Urinary Prostaglandins 5)Frequency of analgesics usage

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Female
• Exclude criteria: 1) Subjects who are pregnant, lactating, or possibly pregnant 2) Subjects who wish to become pregnant during the study period 3) Subjects who have histories of gynecologic disorder* or have gynecologic disorder * Secondary Amenorrhea, Dysmenorrhea, Endometriosis, Uterine Fibroids, Premenstrual Dysphoric Disorder (PMDD), Breast Cancer, Cervical Cancer, Uterine Body Cancer, Ovarian Cancer, etc. 4) Subject with allergy to milk, wheat,egg, shrimp, crab, peanuts, walnuts, 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 who take regularly pharmaceuticals (including Chinese medicine and pill) or supplements which have the possibility to affect the results of the present study from 2 months before the time of informed consent to the day of informed consent 8) Subjects with a history or present illness of a mood disorder or a score of 60 or higher on the Self-Rating Depression Scale (SDS). 9) Subjects classified as psychosomatic (Type IV) by the CMI health questionnaire 10) Subjects with a score of 20 and above for the stress score on the Brief Stress Level Check List 11) Subjects whose total score of menstrual symptoms survey items (Screening test) at the point of postmenstrual period is higher by 1 point or more compared to the total score of the survey items before a menstrual period begins or during menstrual period in menstrual symptoms survey items 12) Subject who is ineligible for this study due to medical doctor's

Related Information

• Primary Sponsor: Leverage Brain Inc.
• Source(s) of Monetary Support: Meiji Co., Ltd.