Healthy adult female
Conditions
Interventions
Consumption of study foods for 3 menstrual cycles
Consumption of control foods for 3 menstrual cycles
Sponsors
Leverage Brain Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subjects who received sufficient explanation of the purpose and contents of this study, have the ability to consent, volunteered of their own free will after fully understanding, and agreed to participate with a written document. 2)Healthy adult females whose age of 20 years or more and less than 40 years at the time of obtaining informed consent. 3)Subjects whose menstrual cycles are within the range of 25 to 38 days each, calculated from their menstrual history of six previous cycles, and whose usual menstrual duration is 3 to 7 days. 4) Subjects who are aware of any menstrual symptoms from 3 days before the start of menstruation to the third day of menstruation.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual Distress Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
Leverage Brain Inc. Clinical Trial Department
Outcome results
None listed