Unique ID issued by UMIN | UMIN000020995 |
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Receipt number | R000024237 |
Scientific Title | Effects of antioxidants supplementation on the quality of life |
Date of disclosure of the study information | 2017/12/19 |
Last modified on | 2018/07/13 15:56:39 |
Effects of antioxidants supplementation on the quality of life
Effects of antioxidants supplementation on the quality of life
Effects of antioxidants supplementation on the quality of life
Effects of antioxidants supplementation on the quality of life
Japan |
Healthy subjects
Adult |
Others
NO
To investigate the effects about 8 weeks antioxidants supplementation on the quality of life by a randomized, double-blind, placebo-controlled study.
Efficacy
The 'Vitality' scores in the questionnaire of health related QOL.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Period:8 weeks
Supplementation:Antioxidants
Period:8 weeks
Supplementation:Placebo
40 | years-old | <= |
69 | years-old | >= |
Male and Female
1.Healthy Japanese subjects aged from 40 to 69 years old
2.Subjects who are office workers.
3.Subjects who feel tired or low in vitality.
4.Subjects who have the 'Vitality' scores lower than 62.8(the national standard value) in SF-36 v2 (the questionnaire of the health related QOL) .
1.Subjects who have the history of diabetes, liver disease, kidney disease, heart disease, respiratory disease, chronic fatigue syndrome, or other severe diseases
2.Subjects who have had the surgery of the digestive tract.
3.Subjects who have the disease under treatment.
4.Subjects who have food or chemical allergies.
5.Smoker.
6.Subjects who regularly use health food, supplements, medicines (for example, statins, anti-hypertensive agents, hypoglycemic agents, or warfarine) or have used them within 1 month.
7.Subjects who drink excessive alcohol, or who can not stop drinking alcohol for the test day and the day before the test day.
8.Subjects who have been suffering from anemia.
9.Subjects who plays heavyexercise or who are on a diet restriction.
10.Subjects who is pregnant or breastfeeding
11.Subjects who take part in another clinical study during the study.
12.Subjects whose BMI are less than 18.5 or over 25.0.
13.Subjects whose clinical test value, blood pressure, pulse rate are markedly over or below the standard value.
14.Subjects deemed unsuitable by the investigator for other reasons
76
1st name | |
Middle name | |
Last name | Naoki Miura |
Medical Corporation Kanonkai Miura Clinic
Internal Medicine
1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
06-6135-5200
tterashima@miula.co.jp
1st name | |
Middle name | |
Last name | Makoto Terashima |
Oneness support Co., Ltd.
Clinical trial Division
1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
06-4801-8917
shiken@oneness-sup.co.jp
Oneness support Co., Ltd.
KYOWA HAKKO BIO CO., LTD
Profit organization
NO
2017 | Year | 12 | Month | 19 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 28 | Day |
2016 | Year | 02 | Month | 15 | Day |
2016 | Year | 02 | Month | 12 | Day |
2018 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024237
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