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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018269
Receipt No. R000021140
Scientific Title A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Date of disclosure of the study information 2015/07/13
Last modified on 2016/07/20

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Basic information
Public title A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Acronym A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Scientific Title A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Scientific Title:Acronym A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Region
Japan

Condition
Condition hyperuricemia
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of decreasing serum uric acid level and safety by ingestion of botanical ingredient-containing foods
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum uric acid level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Botanical ingredient-containing foods, 12 Weeks
Interventions/Control_2 Botanical ingredient-free foods, 12 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 and Female
Key inclusion criteria 1) 20 years of age or older
2) 6.0 mg/dL <= serum uric acid level < 9.0 mg/dL
3) With no treatment.
4) Submitting the written informed consent before this study.
Key exclusion criteria 1) With gouty arthritis and gouty arthritis.
2) With high serum uric acid level (>= 8.0 mg/dL) and kidney damage, urinary stone, hypertension, ischemic cardiac disease, diabetes, metabolic syndrome.
3) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food.
4) Female in pregnancy, lactation and scheduled pregnancy period.
5) Investigator's judgment for other reason.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Nakamura
Organization Suntory Global Innovation Center Limited
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0460
Email Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Obata
Organization Suntory Global Innovation Center Limited
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0568
Homepage URL
Email Hidenori_Obata@suntory.co.jp

Sponsor
Institute New Drug Research Center, Inc.
Institute
Department

Funding Source
Organization Suntory Beer Limited
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
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
2015 Year 07 Month 13 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
2015 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 10 Day
Last modified on
2016 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021140

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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