UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036345 |
|---|---|
| Receipt number | 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 17:30:03 |
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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
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
shunji.oshima@asahigroup-holdings.com
Sponsor or person
Institute
Asahi Quality and Innovations, Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041410
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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