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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029679
Receipt No. 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

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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
Email 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
Email matsuoka@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033912

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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