N/A (healthy adults)
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Japanese males aged 40-65 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]Individuals using medical products. [4]Individuals who have a history of diabetes, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, mental disease, taste disorder or anemia. [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6]Individuals who are a patient or have a history of or endocrine disease. [7]Individuals who use a drug to treat a disease in the past 1 month. [8]Individuals whose BMI is over 30. [9]Individuals who are sensitive to foods, and medical products. [10]Individuals who are a patients of periodontal disease or oral cavity disease and bleeding tendency with tooth brushing. [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 are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [14]Individuals who are a smoker. [15]Individuals whose life style will change during the test period (ex. travel for a long time). [16]Individuals who participated in other clinical studies in the past three months. [17]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [18]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, International Index of Erectile Function, Japanese Translation of Profile of Mood States; Week 0, Week 4, Week 8). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary index [1]Salivary testosterone (Week 0, Week 4, Week 8). *Safety indexes [1]Blood pressure, pulsation (Week 0, Week 4, Week 8) . [2]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8). [3]Doctor's questions (Week 0, Week 4, 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