N/A(healthy adults)
Conditions
Interventions
12 weeks).
Oral ingestion of the placebo products (2 pills/day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Males aged 40-65 years of postmenopausal females. [2]Individuals who are healthy and don't receive treatment. [3]Individuals who have menopausal symptom(s). [4]Individuals who fell fatigued, are bad falling asleep, or sleep badly. [5]Individuals whose written informed consent has been obtained. [6]Individuals who can come to the designated venue for this study and be inspected. [7]Individuals judged appropriate for the trial by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. Individuals who use a drug for treatment of disease. [3]Individuals who use a drug to treat a disease in the past 1 month. [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals who conduct hormone replacement therapy. [7]Individuals whose BMI is over 30. [8]Individuals with serious anemia. [9]Individuals who are sensitive to a test product or other foods, and medical products. [10]Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [13]Individuals who will ingest health-promoting foods, foods for specified health uses, health foods, or supplements. [14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [17]Individuals judged inappropriate for the trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Simplified Menopausal Index (Screening, Week 0, Week 4, Week 8, Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Anti-Aging QOL Common Questionnaire (Screening, Week 0, Week 4, Week 8, Week 12). [2]SF-36v2 Japanese version (Week 0, Week 4, Week 8, Week 12). [3]OSA sleep inventory (Week 0, Week 4, Week 8, Week 12). [4]Evaluation of the brain function with Cognitrax (Screening, Week 0, Week 12). *Safety [1]Blood pressure (Screening, Week 0, Week 8, Week 12). [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 8, Week 12). [3]Blood test (Week 0, Week 12). [4]Blood biochemical test (Week 0, Week 12). [5]Endocrine examination (Week 0, Week 12). [6]Urine analysis (Week 0, Week 12). [7]Doctor's questions (Screening, Week 0, Week 8, Week 12). [8]Subject's diary (From the first day of ingestion of a test material to the last day of the test). *Other index [1]Evaluation of equol-producing ability (Screening). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN Administrative Department of Clinical Trials
Outcome results
None listed