Unique ID issued by UMIN | UMIN000024579 |
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Receipt number | R000028288 |
Scientific Title | A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level. |
Date of disclosure of the study information | 2016/10/31 |
Last modified on | 2017/04/28 10:05:07 |
A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
Japan |
Not applicable
Not applicable | Adult |
Others
NO
The objective is to monitor the changes in serum uric acid level after single-dose of botanical ingredient-containing food, which will clarify the effective dose preliminarily.
Safety,Efficacy
Pragmatic
Not applicable
Efficacy : Area under the curve of serum uric acid level.
Safety : Incidence of adverse effects
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
At the first term(Day1), subjects take test food 1. After 6-days of washout, at the second term(Day8), subjects take either (1)test food 2 or (2)placebo. After 6-days of washout, at the third term(Day15), subjects take the opposite food of the second term. (For example, subjects should take placebo if they take test food 2 at the second term.)
In each time, subjects take Inosine 5'-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.
At the first term(Day1), subjects take test food 2. After 6-days of washout, at the second term(Day8), subjects take either (1)placebo or (2)test food 1. After 6-days of washout, at the third term(Day15), subjects take the opposite food of the second term.
In each time, subjects take Inosine 5'-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.
At the first term(Day1), subjects take placebo. After 6-days of washout, at the second term(Day8), subjects take either (1)test food 1 or (2)test food 2. After 6-days of washout, at the third term(Day15), subjects take the opposite food of the second term.
In each time, subjects take Inosine 5'-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.
20 | years-old | <= |
Not applicable |
Male
(1)Healthy male subjects aged 20 years old or more.
(2)Subjects with serum uric acid level more than or equal to 7.1 mg/dL, and less than 9.0 mg/dL.
(3)Subjects who can visit hospital on the designated day.
(4)Subjects who agree with the given description and express written informed consent.
(1)Subjects with symptom of gouty arthritis or gouty node.
(2)Subjects with serum uric acid level more than or equal to 8.0 mg/dL, who are suffered from complications such as kidney damage, urinary stone, hypertension, ischemic cardiac disease, and diabetes.
(3)Subjects with UUA/UCr less than or equal to 0.40, where UUA and UCr stand for urinary uric acid and urinary creatinine level, respectively.
(4)Subjects whose systolic blood pressure is less than 90mmHg.
(5)Subjects who donated more than 200 mL of blood and/or blood components within the past four weeks prior to the current study.
(6)Subjects who donated more than 400 mL of blood within the last three months prior to the current study.
(7)Subjects whose accumulated amount of donated blood would excess 1200 mL over the past 12 months, if the amount of blood sampling in the current study is added.
(8)Subjects who are participating in other clinical studies, or who finished the clinical study within the last four weeks.
(9)Subjects with disease on heart, liver, or kidney.
(10)Subjects with a previous history of disease on circulatory organs.
(11)Subjects diagnosed with diabetes.
(12)Subjects who have allergic reaction to drug medicine and food.
(13)Subjects who drink alcohol a lot and smoke a lot.
(14)Subjects who have an irregular eating pattern.
(15)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(16)Subjects who have tested positive for infectious disease
(17)Subjects who have difficulty in swallowing.
(18)Subjects who are judged as unsuitable for the current study by the principal investigator for other reasons.
9
1st name | |
Middle name | |
Last name | Norihito Murayama |
Suntory Global Innovation Center Ltd.
Innovation Development Department
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
050-3182-0588
Norihito_Murayama@suntory.co.jp
1st name | |
Middle name | |
Last name | Shinya Fukizawa |
Suntory Global Innovation Center Ltd.
Innovation Development Department
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
050-3182-0595
Shinya_Fukizawa@suntory.co.jp
Suntory Global Innovation Center Ltd.
Suntory Global Innovation Center Ltd.
Self funding
Japan
NO
チヨダパラメディカルケアクリニック(東京都)/Chiyoda Paramedical Care Clinic (Tokyo)
2016 | Year | 10 | Month | 31 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 20 | Day |
2016 | Year | 10 | Month | 31 | Day |
2016 | Year | 10 | Month | 27 | Day |
2017 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028288
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