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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036345
Receipt No. R000041410
Scientific Title Inhibitory effects of amino acids against increasing in serum uric acid levels induced by purine ingestion: a randomized, single-blind, crossover study
Date of disclosure of the study information 2019/04/01
Last modified on 2019/08/07

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Basic information
Public title Inhibitory effects of amino acids against increasing in serum uric acid levels induced by purine ingestion: a randomized, single-blind, crossover study
Acronym Effects of amino acids against increasing in serum uric acid levels induced by purine ingestion
Scientific Title Inhibitory effects of amino acids against increasing in serum uric acid levels induced by purine ingestion: a randomized, single-blind, crossover study
Scientific Title:Acronym Effects of amino acids against increasing in serum uric acid levels induced by purine ingestion
Region
Japan

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

Objectives
Narrative objectives1 The randomized, single-blind, crossover clinical trial is conducted to confirm the serum uric acid-lowering effects of combined supplementation with amino acids against purine-induced serum uric acid increase in healthy male subjects aged 20 - 64 years with decreased kidney excretion of uric acid.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum uric acid concentration
Key secondary outcomes Excretion amount of urinary uric acid, urinary pH

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of 100 ml water contained 0.2g purine bodies
Interventions/Control_2 Ingestion of 100 ml water contained 0.2g purine bodies and essential amino acid
Interventions/Control_3 Ingestion of 100 ml water contained 0.2g purine bodies and non-essential amino acid
Interventions/Control_4 Ingestion of 100 ml water contained 0.2g purine bodies, essential, and non-essential amino acids
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
Key inclusion criteria 1.20 - 64 years old
2.Healthy male
3.Type of decrease in urinary excretion of uric acid (<0.48 mg/kg/h)
Key exclusion criteria 1.Volunteers with a history of diabetes, liver, renal, and heart
2.Volunteers who conducting exercise or diet therapy
3.Volunteers who taking a medicine daily
4.Volunteers with a history of severe diseases ingested medicines
5.Volunteers with a history of drug or food allergy
6.Volunteers with routine use medicines or dietary supplements concerning uric acid-lowering effect
7.Volunteers who participated other clinical trial within three months
8.Volunteers with hepatitis B antigen
9.Volunteers who are judged not to be appropriate as the subjects in this trial
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Nakamura
Organization Asahi Quality and Innovations, Ltd.
Division name Core Technology Laboratories Director
Zip code 302-0106
Address 1-21,Midori 1-chome,Moriya-shi,Ibaraki
TEL 0297-46-1502
Email yasunori.nakamura@asahigroup-holdings.com

Public contact
Name of contact person
1st name Shunji
Middle name
Last name Oshima
Organization Asahi Quality and Innovations, Ltd.
Division name Core Technology Laboratories Principal Researcher
Zip code 302-0106
Address 1-21,Midori 1-chome,Moriya-shi,Ibaraki
TEL 0297-46-9351
Homepage URL
Email shunji.oshima@asahigroup-holdings.com

Sponsor
Institute Asahi Quality and Innovations, Ltd.
Institute
Department

Funding Source
Organization Asahi Quality and Innovations, Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Suda Clinic institutional review board
Address 2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel 03-6205-6222
Email suda-clinic_irb@imeq.co.jp

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
2019 Year 04 Month 01 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
2019 Year 03 Month 18 Day
Date of IRB
2019 Year 03 Month 27 Day
Anticipated trial start date
2019 Year 04 Month 08 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041410

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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