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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037529
Receipt No. R000042786
Scientific Title An effectiveness confirmation test of test food consumption
Date of disclosure of the study information 2020/07/29
Last modified on 2020/07/30

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Basic information
Public title An effectiveness confirmation test of test food consumption
Acronym An effectiveness confirmation test of test food consumption
Scientific Title An effectiveness confirmation test of test food consumption
Scientific Title:Acronym An effectiveness confirmation test of test food consumption
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm effectiveness on blood miRNA in human by consumption of test food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Level of blood miRNA
Key secondary outcomes Level of blood total protein
Level of blood albumin
Level of blood AST
Level of blood ALT
Level of blood LDH
Level of blood total bilirubin
Level of blood ALP
Level of blood gamma-GTP
Level of blood CPK
Level of blood BUN
Level of blood CRE
Level of blood UA
Level of blood Na
Level of blood Cl
Level of blood K
Level of blood Ca
Level of blood total cholesterol
Level of blood LDL-cholesterol
Level of blood HDL-cholesterol
Level of blood triglyceride
Level of blood glucose

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are 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 two tablets of test food which contain pterostilbene for four weeks
Interventions/Control_2 Intake two tablets of test food which contain pterostilbene for four 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
45 years-old <=
Age-upper limit
64 years-old >=
Gender Male
Key inclusion criteria 1)Males aged 45-64 years at a time of obtaining informed consent.
2)Subjects who show understanding of the clinical study procedures and agreement with participating this study by written informed consent.
Key exclusion criteria 1)Subjects who are currently receiving medication.
2)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
3)Subjects who have excessive alcohol intake.
4)Subjects who constantly use oral medicines, Food for Specified Health Uses (FOSHU), functional foods, supplements and/or healthy foods having a possibility of affecting test results.
5)Subjects who have extremely irregular dietary habits, have midnight work or irregular shift work.
6)Subjects who have allergy to medicines or foods (especially gelatin).
7)Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it.
8)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
9)Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
10)Subjects who is going to be collected over 1200mL blood and/or blood components which is collected whithin the last 12 month and at this study
11)Subjects judged as unsuitable for the study by the principal or attending investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shukuko
Middle name
Last name Ebihara
Organization Chiyoda Paramedical Care Clinic
Division name Director
Zip code 101-0047
Address 2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-5548
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Kuriki
Organization Kewpie Corporation
Division name Evaluation & Analysis Sciences Department Institute of Technology Solutions, R&D Division
Zip code 182-0002
Address 2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo 182-0002, Japan.
TEL 03-5384-7759
Homepage URL
Email daisuke_kuriki@kewpie.co.jp

Sponsor
Institute Kewpie Corporation
Institute
Department

Funding Source
Organization Kewpie Corporation
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 Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email 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
2020 Year 07 Month 29 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 100
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
2019 Year 07 Month 21 Day
Date of IRB
2019 Year 07 Month 19 Day
Anticipated trial start date
2019 Year 07 Month 30 Day
Last follow-up date
2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 29 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042786

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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