None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Japanese males aged 40-64 years. [2] Individuals who are healthy and are not received treatment of disease. [3] Individuals who have physical, mental, and sexual general malaise of male menopause. [4] Individuals whose written informed consent has been obtained. [5] Individuals who can come to the designated venue for this study and be inspected. [6] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals whose AMS' total score is over 50. [2] Individuals whose AMS' mental subscale score is over 12. [3] Subjects who score 10 or more on QIDS-J [4] Individuals using medical products. [5] Individuals who have a history of diabetes, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, mental disease, taste disorder or anemia. [6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [7] Individuals who are a patient or have a history of or endocrine disease. [8] Individuals who use a drug to treat a disease in the past 1 month. [9] Individuals whose BMI is over 30. [10] Individuals who are sensitive to foods, and medical products. [11] Individuals who will ingest health-promoting foods, foods for specified health uses, health foods, or supplements. [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 had a habit to ingest health functional foods (ex. Food for Specified Health Uses), health foods or supplements with effects on sleep or physical fatigue in the past 1 month or will ingest those foods during the test period. [14] Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [15] Individuals who are a smoker. [16] Individuals whose life style will change during the test period (ex. travel for a long time). [17] Individuals who participated in other clinical studies in the past three months. [18] Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [19] Individuals judged inappropriate for the trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes to evaluate vitality and energy (Aging Male Symptoms; Week 0, Week 4[home survey], Week 8). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Visual Analogue Scale (Week 0,Week 4[home survey], Week 8). [2] Blood testosterone (Week 0, Week 8). *Safety indexes [1] Blood pressure, pulsation (Week 0, Week 8). [2] Weight, body fat percentage, BMI (Week 0, Week 8). [3] Doctor's questions (Week 0, Week 8). [4] Subject's diary(From the first day of ingestion of a test material to the last day of the test). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed