Healthy adult
Conditions
Interventions
Ingestion of test food anytime except before going to bed. Or ingestion of test food before going to bed.
Sponsors
TTC Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Female older than 45 years and younger than 55 years (2) Subjects who are aware of aging irregular menstruation, indefinite complaints and poor sleep (3) Subjects who can appropriately conduct heart rate and activity surveys (4) Subjects judged to be healthy by a doctor
Exclusion criteria
Exclusion criteria: (1) Subjects who can not properly collect hair, saliva and blood flow test (2) Subjects with history, treatment history, medication, or health food intake affecting the assessment of climacteric symptoms (3) Subjects with history, treatment history, medication, or health food consumption that affect sleep assessment (4) Subjects who have passed more than one year after menopause (5) Subjects who take excessive amounts of soybean products such as natto and soy beverages (6) Subjects who take foods rich in lactic acid bacteria (yogurt, lactic acid bacteria beverages, etc.) at least three times a week (7) Subjects who have undergone oophorectomy or hysterectomy (8) Excessive smokers, alcohol addicts, and subjects with extremely irregular diets (9) Subjects whose overall score of the Pittsburgh Sleep Questionnaire at the pre-examination is less than 3, or more than 10, or who are estimated to have sleep disorders such as insomnia from the answers (10) Subjects whose BMI are 30.0 kg/m^2 or more (11) Subjects who are awakened midway through external factors such as child crying at least twice a week (12) Night and day shift worker or manual laborer (13) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion (14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (15) Subjects who are judged as unsuitable for the study because of clinical test, anthropometric test and physical examination in pre-inspection (16) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (17) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study (18) Subjects who are judged as unsuitable for the study by investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Kohnenki Shogai Index (KKSI) at 8 weeks ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Swelling 2. Blood flow 3. Stiff shoulder VAS 4. QOL questionnaire (SF-36) 5. Pittsburgh Sleep Quality Index (PSQI-j) 6. OSA sleep inventory MA version 7. Heart rate / activity survey | — |
Countries
Japan
Contacts
Public ContactShinsuke Tsuji
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed