UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026717 |
|---|---|
| Receipt number | R000030649 |
| Scientific Title | Effect of test supplement on serum uric acid: A randomized, double blinded, placebo controlled, and parallel group comparison study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/12/04 17:36:25 |
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Basic information
Public title
Effect of test supplement on serum uric acid: A randomized, double blinded, placebo controlled, and parallel group comparison study
Acronym
Effect of test supplement on serum uric acid
Scientific Title
Effect of test supplement on serum uric acid: A randomized, double blinded, placebo controlled, and parallel group comparison study
Scientific Title:Acronym
Effect of test supplement on serum uric acid
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effect of test supplement on serum uric acid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum uric acid
Key secondary outcomes
Urinary excretion of uric acid,
uric acid clearance, creatinine clearance, uric acid clearance/creatinine clearance ratio
Subgroup analysis using serum uric acid levels and other clinical measurements
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test supplement for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo for 12 consecutive 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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1.Subjects aged from 20 to 65 years old
2. Subjects whose serum uric acid levels are included within a range of 6.0 mg/dL to 7.0 mg/dL
Key exclusion criteria
1. Subjects who usually take some medicine, foods for specified health uses, foods with function claims, health foods, or cosmetics including active ingredients
2. Subjects who have been taking foods affecting the study results once a week or more
3. Subjects who have gout in the past or are currently receiving treatment for hyperuricemia or gout (including exercise therapy, dietary guidance)
4. Subjects who are under treatment or have history of diseases (urinary stone, kidney stone, rheumatoid arthritis) which may influence the outcome of the study
5. Subjects who routinely use analgesics (non-steroidal analgesics, steroidal analgesics, etc.).
6.Subjects who habitually do intense exercise such as marathon
7. Subjects who cannot carry out the procedures of various inspections to be carried out during the research as specified (24 hour urine collection etc)
8. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication therapy
9. Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
10. Subjects with allergies to the test food in the study
11. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
12. Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
13. Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
14. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Shimizu |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
Homepage URL
shimizu_yoshiki@fancl.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
医療法人健昌会 福島健康管理センター
いきいきクリニック
メディカルステーションクリニック
医療法人社団絆 アーバンハイツクリニック
Other administrative information
Date of disclosure of the study information
| 2017 | 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
| 2017 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 28 | 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
| 2017 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030649
