Unique ID issued by UMIN | UMIN000026288 |
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Receipt number | R000030196 |
Scientific Title | Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans |
Date of disclosure of the study information | 2017/02/24 |
Last modified on | 2018/09/10 10:18:01 |
Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Japan |
Healthy Adult
Adult |
Others
NO
Acacia bark extract is overdosed by healthy adults and safety is evaluated
Safety
Inquiry, physical examination, and medical examination by hematology, blood biochemistry, urinalysis
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
4-week continuous intake of acacia bark extract
4-week continuous intake of placebo
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) 20<=Age=<64 of healthy men and women
(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases
(2) Subjects who indicate disorder of heart and lung function
(3) Subjects who indicate abnormal parameter in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease under treatment now
(6) Subjects with drug or food allergy
(7) Subjects who play high intensity sports or are on a diet
(8) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods
(9) Subject who consume exscessive alcohol
(10) Smoker
(11) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(12) Subjects who is participating in the other study or plannning to participate during the study period
(13) Subjects who isdeemed unsuitable by the principal investigator
30
1st name | |
Middle name | |
Last name | Naoki Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal Medicine
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
06-6135-5200
info@miura-cl.jp
1st name | |
Middle name | |
Last name | Makoto Terashima |
Oneness support Co., Ltd.
Clinical trial Division
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
mimozax Co., Ltd.
Profit organization
NO
2017 | Year | 02 | Month | 24 | Day |
Published
Completed
2017 | Year | 01 | Month | 06 | Day |
2017 | Year | 02 | Month | 27 | Day |
2017 | Year | 02 | Month | 24 | Day |
2018 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030196
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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