UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058823 |
|---|---|
| Receipt number | R000067148 |
| Scientific Title | A study to evaluate the effect of the food containing peptides intake on serum uric acid |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/08/18 09:25:54 |
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Basic information
Public title
A study to evaluate the effect of the food containing peptides intake on serum uric acid
Acronym
A study to evaluate the effect of the food containing peptides intake on serum uric acid
Scientific Title
A study to evaluate the effect of the food containing peptides intake on serum uric acid
Scientific Title:Acronym
A study to evaluate the effect of the food containing peptides intake on serum uric acid
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the effect of continuous consumption of the test food for 12 weeks on uric acid levels in Japanese males aged 20 years and older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum uric acid
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of food containing peptides for 12 weeks
Interventions/Control_2
Continuous intake of placebo foods 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
| Not applicable |
Gender
Male
Key inclusion criteria
1.Healthy Japanese men aged 20 years or old at the time of obtaining written consent.
2.Subjects with a serum uric acid level between 6.0mg/dL and 7.9mg/dL at SCR. (More than half of the subjects should have a uric acid level between 6.0mg/dL and 7.0mg/dL.)
3.Subjects who have received sufficient explanation of the purpose and content of the research, and have the ability to consent.
Key exclusion criteria
1.Subjects who are currently undergoing medical treatment or have a medical history of hyperuricemia, gout, or urolithiasis.
2.Subjects receiving medication or outpatient treatment for a serious disease.
3.Subjects receiving exercise or diet therapy under the supervision of a physician.
4.Subjects who may develop an allergy to the ingredient of the test food (fish) or aspirin
5.Subjects who have a history of drug dependence or alcohol dependence or have a current medical history.
6.Subjects who have extremely irregular life rhythms due to night work, shift work, etc.
7.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more).
8.Subjects who have a history or current illness of serious diseases such as brain disease, malignant tumor, immune disease, kidney disease, liver disorder, cardiovascular disorder, endocrine disorder, or other metabolic disorders.
9.Subjects who use or are unable to stop using health foods, supplements, and drugs that may affect uric acid level.
10.Subjects who are participating in other clinical studies now, or are willing to participate within 3 months prior to the date of obtaining consent.
11.Subjects who has participated in blood collection or donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent.
12.Subjects who have difficulty complying with recording of each survey form.
13.Subject whose various test results at screening indicate their ineligibility to participate in the study.
14.Subjects who are judged unsuitable for the study by the investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo Japan
TEL
03-3431-1260
rd@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Nissui Corporation
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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.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
| 2025 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067148
