UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028828 |
|---|---|
| Receipt number | R000032994 |
| Scientific Title | Evaluating the effect of the test food on serum uric acid and urinary excretion uric acid of adult males |
| Date of disclosure of the study information | 2018/11/18 |
| Last modified on | 2018/05/22 09:21:58 |
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Basic information
Public title
Evaluating the effect of the test food on serum uric acid and urinary excretion uric acid of adult males
Acronym
Evaluating the effect of the test food on serum uric acid and urinary excretion uric acid of adult males
Scientific Title
Evaluating the effect of the test food on serum uric acid and urinary excretion uric acid of adult males
Scientific Title:Acronym
Evaluating the effect of the test food on serum uric acid and urinary excretion uric acid of adult males
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the 8-week intake of the test food on serum uric acid and urinary excretion uric acid of males aged 20 to 64 years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum uric acid and Urinary excretion of uric acid
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food for 8 weeks
Interventions/Control_2
Ingestion of the test food for 8 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)Males aged 20 to 64 years
(2)Serum uric acid 7.0-9.0 mg/dL
Key exclusion criteria
(1) Subjects who routinely use health food richly containing nobiletin
(2) Those who have been diagnosed as gout in the past or subjects currently undergoing treatment with hyperuricemia and/or gout
(3) Subjects having renal impairment and /or urinary stone
(4) Subject having serious medical history
(5) Subject having history of digestive organ diseases affecting digestion and absorption, or who has an operation history
(6) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9) Subjects having possibilities for emerging allergy related to the study
(10) Subjects having participated in other clinical studies when this study started
(11) Subjects having plan to go abroad or go to business trips
(12) Subjects having scheduled to become irregular living such as day shift work or night shift
(13) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(14) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikuni Yamamoto |
Organization
OkinawaHam Savoury Food Company
Division name
Quality Control Development Department
Zip code
Address
2822-3 Zakimi, Yomitan-son,Nakagamigun,
TEL
098-958-4330
dpd@okiham.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuto Sakurai |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
k.sakurai@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
OkinawaHam Savoury Food Company
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 18 | 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 | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 27 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032994
