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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033359
Receipt No. 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

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Basic information
Public title Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Acronym Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Scientific Title Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Scientific Title:Acronym Validation study of the hypouricemic effect of a 6-week continuous intake of amino acid mixture on serum uric acid level
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum uric acid levels
Key secondary outcomes Urate clearance,Urinary uric acid excretion

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 6-week intake of the test food
Wash out
6-week intake of the placebo
Interventions/Control_2 6-week intake of the placebo
Wash out
6-week intake of the test food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Email ochitani@huma-rd.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Asahi Group Holdings,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 31 Day
Last follow-up date
2018 Year 11 Month 21 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 18 Day
Date analysis concluded
2018 Year 12 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 11 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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