Healthy Japanese
Conditions
Interventions
Duration: One menstrual cycle Test food: Chocolate Administration: Take 32 g of chocolate per day in two divided doses.
Duration: One menstrual cycle No treatment
Sponsors
TechDoctor, Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic ORTHOMEDICO Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. women 3. Individuals aged 20 or more and less than 40 at the time of agreement to participate in this study (who won't be 40 during the study) 4. Healthy individuals without disease on outpatient visits at screening (before consumption; Scr) 5. Individuals whose menstrual cycle lasts at least 25 days and at most 35 days 6. Individuals whose total score of MDQ is 30 or more at Scr (luteal phase) 7. Individuals who have a smartphone device on which the application can be installed, who do not plan to change their device during the study, and who agree with the terms of use for the wearable device and application used in this study 8. Individuals who have given written consent to participate in this study and have provided their information prior to participation
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker, an implantable cardioverter defibrillator (ICD), or a device that can affect heart rate 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking medications (including herbal medicines) and supplements, particularly who take medications that can affect heart rate 6. Individuals who take chocolate (including quasi-chocolate) every day 7. Individuals who are allergic to medicines and/or foods related to the test product, particularly who show allergic reactions to chocolate, milk, soybeans, eggs, wheat 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who are taking hormonal drugs (such as the pill) or antipsychotics within 2 months prior to participation, or who have been diagnosed with other psychiatric disorders and gynopathy 10. Individuals who may develop skin reaction or other skin problems due to continuous use of wearable devices 11. Individuals who have not had menses for more than 3 months, or who are postmenopausal 12. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 13. Individuals who are judged that have difficulty using the wearable device in the study by the principal investigator 14. Individuals who work a late-night shift 15. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total scores of the Menstrual Distress Questionnaire (MDQ) during the pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Original questionnaire (appetite, sleepiness, mood) during pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases) 2. Autonomic indices coefficient of variation of R-R intervals (CVRR) and standard deviation of normal-to-normal interval (SDNN), heart rate, sleep duration, habitual sleep efficiency, and sleep stages and their durations during pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases) 3. The score of each scale (Pain, Water Reten, Auto React, Negative affect, Impair Conc, Behave Change, Arousal, Control) and each item in the MDQ during pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases) | — |
Countries
Japan
Contacts
Public ContactKosaku Kawada
TechDoctor, Inc. Business Development Department
Outcome results
None listed