Unique ID issued by UMIN | UMIN000024620 |
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Receipt number | R000028167 |
Scientific Title | Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor |
Date of disclosure of the study information | 2018/01/22 |
Last modified on | 2017/05/01 19:38:17 |
Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor
Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor
Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor
Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor
Japan |
N/A(healthy adults)
Adult |
Others
NO
This study examines effect of a food on aging male's physical fatigue reduction, and vitality and vigor.
Safety,Efficacy
[1]Visual Analog Scale for Fatigue (Week 0, Week 6, Week 12)
[2]Total testosterone (Week 0, Week 6, Week 12)
*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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Other |
Oral ingestion of the test products (2 pills/day; 12 weeks)
Oral ingestion of the placebo products (2 pills/day; 12 weeks)
40 | years-old | <= |
65 | years-old | >= |
Male
[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
[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
40
1st name | |
Middle name | |
Last name | Atsuko Mori |
Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Director
1-20-11, Ueno, Taito-ku, Tokyo 110-0005 JAPAN
03-5816-0711
info@tes-h.co.jp
1st name | |
Middle name | |
Last name | Ryoma Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
03-6801-8480
info@tes-h.co.jp
TES Holdings Co. Ltd
Kobayashi Pharmaceutical Co., Ltd.
Profit organization
NO
2018 | Year | 01 | Month | 22 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 16 | Day |
2016 | Year | 10 | Month | 30 | Day |
2016 | Year | 10 | Month | 29 | Day |
2017 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028167
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