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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039465
Receipt No. 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 2020/02/12

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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
Email 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
Email shimamura@m-health-lab.jp

Sponsor
Institute Matsumoto Junior College
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 20 Day
Date of IRB
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 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044997

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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