Unique ID issued by UMIN | UMIN000033359 |
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Receipt number | R000038015 |
Scientific Title | Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level |
Date of disclosure of the study information | 2018/07/30 |
Last modified on | 2019/01/17 15:09:47 |
Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Japan |
Healthy adult
Adult |
Others
NO
The purpose of this study was to verify the effect of continuous intake of amino acid mixtures on serum uric acid levels in healthy adult men and women aged 20 to 65 years whose serum uric acid levels are 6.6 mg/dl or more and 7.9 mg/dl or less, respectively.
Safety,Efficacy
Serum uric acid levels
Urate clearance,Urinary uric acid excretion
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
Central registration
2
Prevention
Food |
6-week intake of the test food
Wash out
6-week intake of the placebo
6-week intake of the placebo
Wash out
6-week intake of the test food
20 | years-old | <= |
65 | years-old | > |
Male and Female
1.Age: 20 years or older, less than 65 years
2.Gender: Male and female Japanese nationality
3.Patients who have shown a serum uric acid level of 7.9 mg/dl or higher and 6.6 mg/dl or lower in both the primary screening and the secondary screening.
1.Persons with or who have a history of diseases such as diabetes mellitus, liver disease, kidney disease, or heart disease.
2.Currently, exercise therapy and diet therapy are performed under the supervision of a physician.
3.Persons with diseases requiring continuous medication
4.Persons with a history of serious illness requiring medication.
5.Patients with a history of drug or food allergy
6.Patients who are currently taking health foods and supplements that affect uric acid levels (e.g., those containing chitosan, anserine, chrysanthemum polyphenols, PA-3, etc.)
7.Subjects who are currently taking drugs or quasi-drugs that affect uric acid levels
8.Anthropometric, physical examination, and laboratory test values that significantly deviate from the reference range on the pre-examination basis.
9.Subjects who are pregnant, breast-feeding, or willing to become pregnant during the study period
10.Patients with a current or past history of psychiatric disorders (depression, etc.)
11.Employees working during night shifts, etc.
12.Alcoholism, drug dependence, and drug abusers who are or have a history of treatment
13.Subjects who have participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period.
14.Other than the above, the principal investigator judged the subject to be inappropriate.
32
1st name | |
Middle name | |
Last name | Ochitani Daisuke |
HUMA R&D CORP
Clinical Development Division
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
81-3-3431-1260
ochitani@huma-rd.co.jp
1st name | |
Middle name | |
Last name | Ochitani Daisuke |
HUMA R&D CORP
Clinical Development Division
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
81-3-3431-1260
ochitani@huma-rd.co.jp
HUMA R&D CORP
Asahi Group Holdings,Ltd
Profit organization
Japan
NO
2018 | Year | 07 | Month | 30 | Day |
Unpublished
Completed
2018 | Year | 06 | Month | 08 | Day |
2018 | Year | 07 | Month | 31 | Day |
2018 | Year | 11 | Month | 21 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 12 | Month | 18 | Day |
2018 | Year | 12 | Month | 28 | Day |
2018 | Year | 07 | Month | 11 | Day |
2019 | Year | 01 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038015
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