Unique ID issued by UMIN | UMIN000023663 |
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Receipt number | R000027258 |
Scientific Title | Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study- |
Date of disclosure of the study information | 2016/08/19 |
Last modified on | 2017/01/23 17:30:50 |
Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study-
Effect of ingestion of trial supplement on serum uric acid level
Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study-
Effect of ingestion of trial supplement on serum uric acid level
Japan |
Healthy male subject
Adult |
Others
YES
This study is aimed to verify improvement effect of trial supplement on serum uric acid level.
Efficacy
Exploratory
Not applicable
Serum uric acid level
Urine uric acid level
Subgroup analysis using SNP
Relationship among serum uric acid, urine uric acid, and SNP
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
4
Treatment
Food |
Ingestion of trial supplement A for 4 weeks
Ingestion of trial supplement B for 4 weeks
Ingestion of trial supplement C for 4 weeks
Ingestion of placebo for 4 weeks
20 | years-old | <= |
65 | years-old | > |
Male
1) Japanese males aged from 20 to less than 65 years old.
2) Subjects whose serum uric acid levels are included within 6.0mg/dL and 8.0mg/dL.
1) Subjects who are under treatment or have a history of hyperuricemia or gout.
2) Subjects who have a history of gouty arthritis or gouty arthritis.
3) Subjects who are under treatment or have a history of rheumatoid arthritis.
4) Subjects who have a history of urinary stone or kidney stone.
5) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor
6) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease.
7) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of serum uric acid.
8) Subjects who routinely use or are planned to use analgesics (non-steroidal analgesics, steroidal analgesics, etc.).
9) Subjects with allergies to the products used in the study.
10) Subjects who are planned to change their lifestyle.
11) Subjects who have participated in other clinical study within the last one month prior to the current study
12) Subjects who are judged as unsuitable for the study by the investigator for other reason
40
1st name | |
Middle name | |
Last name | Kumie Ito |
Nihonbashi Sakura Clinic
Assistant director
5F,Inamura Building,1-9-2, Nihonbashikayabacho,Chuo-ku, Tokyo, Japan
03-6661-9061
k-ito@ouryokukai.jp
1st name | |
Middle name | |
Last name | Yoshiki Shimizu |
FANCL CORPORATION
Research institute
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, Japan
045-820-3755
shimizu_yoshiki@fancl.co.jp
FANCL Corporation
None
Self funding
Japan
NO
医療法人社団桜緑会 日本橋さくらクリニック
2016 | Year | 08 | Month | 19 | Day |
Unpublished
Completed
2016 | Year | 08 | Month | 17 | Day |
2016 | Year | 08 | Month | 21 | Day |
2016 | Year | 08 | Month | 18 | Day |
2017 | Year | 01 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027258
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