UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033843 |
|---|---|
| Receipt number | R000038598 |
| Scientific Title | A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL |
| Date of disclosure of the study information | 2018/08/24 |
| Last modified on | 2019/09/25 11:22:23 |
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Basic information
Public title
A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Acronym
A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Scientific Title
A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Scientific Title:Acronym
A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to obtain evidence in the Serum uric acid level change in 4 consecutive weeks ingesting test beverage (beverage being testing) for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL by comparing to the control beverage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum uric acid level and it's change
Key secondary outcomes
Urine creatinine, uric acid in the urine and it's change
Urinary uric acid excretion, Uric acid clearance, Creatinine clearance, Uric acid excretion rate and it's change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test beverage (4 weeks).
Interventions/Control_2
Ingestion of control beverage (4 weeks).
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) 20 years of age or older male
2) Subjects with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL at screening
3) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria
1) Subjects who are under drug treatment for hyperuricemia or gout, or subjects who are provided lifestyle guidance by medical doctor
2) Subjects who have history of gout
3) Subject who intake dairy product that is effective in lowering serum uric acid level on a daily basis
4) Subjects who in take health food that is effective in lowering serum uric acid level on daily basis
5) Subjects who exercise vigorously
6) Subjects with urinary tract infection, hepatic disorder, cardiac disorder, urinary tract stone disease, kidney disturbance, hypertension, diabetes, or subjects who have history of medication for those diseases, or subjects who are going to have medication during the study
7) Subjects with daily energy intake of over 4,000 kcal on Food Frequency Questionnaire Based on Food Group, FFQg, at the background investigation
8) Subjects with allergy to milk or soy
9) Subjects who had participated in other clinical trials within 1 month
10) Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator or investigator
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Ide |
| Middle name | |
| Last name | Yumiko |
Organization
Medical Corporation Chisei-kai Tokyo Center Clinic
Division name
Medical Corporation Chisei-kai Tokyo Center Clinic
Zip code
1030028
Address
Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL
07033513779
nakano_satomi@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Nakano |
Organization
Tokyo Center Clinic
Division name
Clinical Research Center
Zip code
1030028
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
07033513779
Homepage URL
nakano_satomi@tc-clinic.jp
Sponsor or person
Institute
3H Medi Solution Inc.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
28F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 24 | 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
71
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 | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 16 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038598
