Effect of the Test Food on Male's Vitality and Energy.
- Conditions
- /A (healthy adults)
- Registration Number
- JPRN-UMIN000037923
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 48
Not provided
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [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 Outcome Measures
Name Time Method *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).