Healthy adult
Conditions
Interventions
Intake of test food for 8 consecutive weeks
Intake of placebo food for 8 consecutive weeks
Sponsors
TTC Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Female older than 45 years and younger than 55 years, male older than 45 years (2) Subjects who are aware of aging irregular menstruation, indefinite complaints and poor sleep (3) Subjects judged to be healthy by a doctor
Exclusion criteria
Exclusion criteria: (1) Subjects who have passed more than one year after menopause (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 ingest excessively soy products such as natto and soy drinks (5) Subjects who take foods rich in lactic acid bacteria (yogurt, lactic acid bacteria beverages, etc.) at least three times a week (6) Subjects who have had ovarian, uterine or orchiectomy surgery (7) Excessive smokers, alcohol addicts, and subjects with extremely irregular diets (8) 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 (9) Subjects whose BMI are 30.0 kg/m^2 or more (10) Subjects who are awakened midway through external factors such as child crying at least twice a week (11) Night and day shift worker or manual laborer (12) 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 (13) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14) Subjects considered unsuitable as subjects based on pre-examination laboratory test values, measurement values, and prostate tumor markers (15) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (16) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study (17) Subjects who are judged as unsuitable for the study by investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire about menopause (KKSI or AMS) at 8 weeks ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stiff shoulder VAS 2. Pittsburgh Sleep Quality Index (PSQI-j) 3. Cortisol 4. DHEA-S 5. Hot flash | — |
Countries
Japan
Contacts
Public ContactShinsuke Tsuji
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed