N/A(healthy adults with general malaise)
Conditions
Interventions
Oral ingestion of the test products containing onion extract (3 pills/day
4 weeks)
Oral ingestion of the placebo products not containing onion extract (3 pills/day
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Japanese males aged 50-79 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 AMS scale is 27-49 [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 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 have a history of heart failure, kidney failure, hepatitis B or hepatitis C [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 UA is over 7.0mg/dl [8]Individuals whose indexes concerning on lipid-based system is 2.0 times higher than the standard value [9]Individuals whose PSA value is over 4.0ng/mL [10]Individuals whose HbA1c(NGSP) is over 6.8 [11]Individuals whose systolic arterial pressure is over 160mmHg or diastolic blood pressure is over 100mmHg [12]Individuals whose BMI is over 30 [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day) [14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [15]Individuals whose average number of cigarettes for smoking is over 21/day [16]Individuals who participated in other clinical studies in the past three months [17]Individuals who are sensitive to foods and medical products [18]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period [19]Individuals who have a habit to intake onion over 200g/day [20]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [21]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Serum testosterone (Screening, Week 0, Week 2, Week 4) [2]Salivary testosterone (Screening, Week 0, Week 2, Week 4) [3]Aging Males' Symptoms scale (Screening, Week 0, Week 2, Week 4) [4]SF-36v2, Japanese version (Screening, Week 0, Week 2, Week 4) [5]IIEF (Screening, Week 0, Week 2, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Hematologic test (Screening, Week 0, Week 2, Week 4) [2]Blood biochemical test (Screening, Week 0, Week 2, Week 4) [3]Urine analysis (Screening, Week 0, Week 2, Week 4) [4]Blood pressure, pulsation (Screening, Week 0, Week 2, Week 4) [5]Weight, body fat percentage, BMI (Screening, Week 0, Week 2, Week 4) [6]Doctor's questions (Screening, Week 0, Week 2, Week 4) [7]Subject's diary(From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd Department of Clinical Trial
Outcome results
None listed