Effect of the Test Food on Male's Vitality and Energy.
- Conditions
- o
- Registration Number
- JPRN-UMIN000048948
- 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
- 60
Not provided
[1] Individuals whose AMS' total score is over 50. [2] Individuals whose AMS' mental subscale score is over 12. [3] Subjects who score 11 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Indexes to evaluate vitality and energy (Aging Male Symptoms ; Week 0, home survey, Week 8).
- Secondary Outcome Measures
Name Time Method *Secondary indexes [1] Visual Analogue Scale (Week 0, home survey, Week 8). [2] Total 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).