UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025942 |
|---|---|
| Receipt number | R000029825 |
| Scientific Title | A confirmation study on improvement effect of serum uric acid level by single consumption of the test food |
| Date of disclosure of the study information | 2017/02/03 |
| Last modified on | 2020/10/05 18:14:28 |
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Basic information
Public title
A confirmation study on improvement effect of serum uric acid level by single consumption of the test food
Acronym
A confirmation study on improvement effect of serum uric acid level by single consumption of the test food
Scientific Title
A confirmation study on improvement effect of serum uric acid level by single consumption of the test food
Scientific Title:Acronym
A confirmation study on improvement effect of serum uric acid level by single consumption of the test food
Region
| Japan |
Condition
Condition
Healthy male adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of rice endosperm protein (REP) for serum uric acid level at consumption of high-purine foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of serum uric acid level during 24-hrs after test food intake.
Key secondary outcomes
Uric acid level in serum at each time point and that in urine collection after test food loading.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Intake of high-purine drink and the suspension which include rice endosperm protein -- Washout 2-week --Intake of high-purine drink and water
Interventions/Control_2
Intake of high-purine drink and water -- Washout 2-week --Intake of high-purine drink and the suspension which include rice endosperm protein
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) Males whose serum uric acid levels are less than or equal to 7.9mg/dL
(2) Males aged 20 years old and over
(3) Subjects who possible to take a blood sample repeatedly with the passage of time
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who have severe disease in liver, kidney, heart, lung, digestive organ, blood, endocrine system or metabolic system.
(2)Subjects who have medical history of gouty arthritis, kidney disease or urinary stone.
(3) Subjects who are received treatment of high blood pressure continuously.
(4)Subjects who are received current treatment for diabetes mellitus.
(5)Subjects who are received a prescription of drugs for hyperlipidemia or blood sugar improvement.
(6) Heavy alcohol drinker.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8)Subjects who participated another test of drug or food within 1-month.
(9)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.
(10)Subjects who have donated over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11)Shift workers.
(12) These having Food for Specified Health Uses (FOSHU) and/or health food.
(13)Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Co.,Ltd.
Division name
Sales & Planning Department
Zip code
101-0047
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
KAMEDA SEIKA 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2017 | Year | 02 | Month | 03 | 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 | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 04 | 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 | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029825
