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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033843
Receipt No. 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

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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
Email 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
Email nakano_satomi@tc-clinic.jp

Sponsor
Institute 3H Medi Solution Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038598

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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