UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018269 |
|---|---|
| Receipt number | 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 14:18:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Hidenori_Obata@suntory.co.jp
Sponsor or person
Institute
New Drug Research Center, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021140
