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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028828
Receipt No. 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

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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
Email 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
Email k.sakurai@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032994

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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