UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039465 |
|---|---|
| Receipt number | R000044997 |
| Scientific Title | Effects of whey hydrolysate ingestion on reduction of serum uric acid level in healthy men: a randomized, double-blind, parallel-group, placebo-controlled study |
| Date of disclosure of the study information | 2020/02/12 |
| Last modified on | 2020/08/17 10:18:56 |
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Basic information
Public title
Effects of whey hydrolysate ingestion on reduction of serum uric acid level
Acronym
Effects of whey hydrolysate ingestion on reduction of serum uric acid level
Scientific Title
Effects of whey hydrolysate ingestion on reduction of serum uric acid level in healthy men: a randomized, double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym
Effects of whey hydrolysate ingestion on reduction of serum uric acid level
Region
| Japan |
Condition
Condition
No applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the whey hydrolysate on reduction of uric acid level
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
Urinary excretion of uric acid,
uric acid clearance, creatinine clearance, uric acid clearance/creatinine clearance ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 12 weeks
Interventions/Control_2
Intake of the control food for 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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1)Subjects aged from 20 to 74 years old.
2)Subjects who show a serum uric acid level from 6.0 to 7.9 mg/dL at preliminary inspection.
Key exclusion criteria
1)Subjects who regularly food or supplement improving the uric acid level.
2)Subjects who are are currently receiving treatment for hyperuricemia or gout.
3)Subjects who are under treatment or have medical history of disease for gout, urinary stone, kidney stone, rheumatoid arthritis.
4)Subjects who have serious disease or medical history in brain, liver, kidney, heart, lung, gastrointestinal tract, or blood, etc.
5)Subjects who excessively take alcohol(alcohol conversion over 60g/day).
6)Subjects who have a medical history of serious allergy to medicine or food.
7)Participants in other clinical trial.
8)Subjects who are judged unsuitable for participating in this study based on subject background, physical finding, and interview by physician.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mitsunaga |
| Middle name | |
| Last name | Miyasaka |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
399-0033
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
mjc-m.miyasaka@matsutan.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Shimamura |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
shimamura@m-health-lab.jp
Sponsor or person
Institute
Matsumoto Junior College
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Matsumoto Junior College
Address
3118, Sasaga, Matsumoto, Nagano, Japan
Tel
0263-58-4417
mjc-m.miyasaka@matsutan.ac.jp
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
| 2020 | Year | 02 | Month | 12 | 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
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044997
