Healthy Japanese subjects
Conditions
Interventions
Daily intake of test food X for 12 weeks
Daily intake of test food Y for 12 weeks
Daily intake of test food Z for 12 weeks
Daily intake of placebo food for 12 weeks
Sponsors
Fujico Co., Ltd.
Naoko Ishiwata (Faculty of Management Department of Life Environments Management, Atomi University)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Females aged 40 or more and 64 or less 2) Subjects whose SMI total score of 50 or less 3) Subjects who experience stress, low mood or fatigue in their daily life 4) Subjects who can give informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)Subjects who are allergic to the test food 2)Subjects who are undergoing medical treatment of gynecological such as climacteric disorder and dysmenorrhea 4) Subjects who are undergoing medical treatment of mental disease 5) Subjects who undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 6)Subjects who are constantly taking pill or herbal medicines 7)Subjects who are undergoing hormone replacement therapy 8) Subjects who have a history of ovariectomy or hysterectomy 9) Subjects who consume 50mg or more of soy isoflavones on a daily basis 10) Subjects who have passed more than 5 years after menopause 11) Subjects who take health food (supplement or "Foods with functional claims" or "Food for specified health uses") affecting fatigue, stress or sleep quality 12) Subjects who are pregnant or lactating, or intending to become pregnant during the study 13) Subjects who took part in another clinical study within 28 days prior to the start of the present study or who is currently taking part in another clinical study 14) Subjects who are judged as ineligible to participate in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS2 Japanese version | — |
Secondary
| Measure | Time frame |
|---|---|
| Simplified Menopausal Index, OSA sleep inventory MA version, VAS (fatigue sensation, shoulder stiffness, coldness, eyestrain, dry mouth), vision test, urinary equol, urinary oxidative stress (TBARS, 8-OHdG), salivary stress marker (cortisol, sIgA, oxytocin), saliva production | — |
Countries
Japan
Contacts
Public ContactChisato Aiso
Fujicco Co., Ltd. Innovation center
Outcome results
None listed