N/A(healthy adults)
Conditions
Interventions
12 weeks)
Oral ingestion of the placebo products (2 pills/day
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 using medical products [2]Individuals who have a habit to use or intake medicine [3]Individuals who have a history of diabetes, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, mental disease, taste disorder or anemia [4]Individuals who use a drug to treat a disease in the past 1 month [5]Individuals who have a history of digestive system disease [6]Individuals whose AST or ALT is 1.5 times higher than the standard value [7]Individuals whose BMI is over 25 [8]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day) [9]Individuals whose average number of cigarettes for smoking is over 21/day [10]Individuals with serious anemia [11]Individuals who are sensitive to test product or other foods, and medical products [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-promoting foods, foods for specified health uses, health foods, or supplements with components contained in the test product in the past 3 month or will ingest those foods during the test period [14]Individuals whose life style will change during the test period (ex. travel for a long time) [15]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [16]Individuals who participated in other clinical studies in the past three months [17]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Visual Analog Scale for Fatigue (Week 0, Week 6, Week 12) [2]Total testosterone (Week 0, Week 6, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Salivary testosterone (Week 0, Week 6, Week 12) [2]SF-36v2 Japanese version (Week 0, Week 6, Week 12) [3]Japanese Translation of Profile of Mood States (Week 0, Week 6, Week 12) *Safety [1]Blood pressure, pulsation (Week 0, Week 6, Week 12) [2]Weight, body fat percentage, BMI (Week 0, Week 6, Week 12) [3]Abdominal perimeter (Week 0, Week 6, Week 12) [4]Hematologic test (Week 0, Week 12) [5]Blood biochemical test (Week 0, Week 12) [6]Urine analysis (Week 0, Week 12) [7]Doctor's questions (Week 0, Week 6, Week 12) [8]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