UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029679 |
|---|---|
| Receipt number | R000033912 |
| Scientific Title | Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/04/10 16:58:08 |
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Basic information
Public title
Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood
Acronym
Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood
Scientific Title
Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood
Scientific Title:Acronym
Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an influence of a test food product on Toxic AGEs (TAGEs) in blood by selecting males aged 30 and over, below 65 as subjects and assigning them to take the test food product for 8 weeks on a continuous basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toxic AGEs (TAGEs) in blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
8-week intake of the test food
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1.Age: 30 or over, below 65
2.Sex: Males
Key exclusion criteria
1.Currently in treatment with medication or currently seeing a doctor for treatment of severe disorder
2.Possible allergic reaction to the test food product
3.Current administration of medication with a possible influence on the study
4.Received vaccination in the past three months or desired to receive vaccination during a study period
5.Extreme faddiness
6.Extremely irregular lifestyle habits such as eating and sleeping habits
7.Current participation in any other clinical study or participation in other clinical study in the past three months
8.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsuoka Masao |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg.10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
matsuoka@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsuoka Masao |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg.10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
matsuoka@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining 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
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 | 03 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 24 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033912
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
