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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036090
Receipt No. R000041116
Scientific Title Preliminary study on the effect of functional food on Blood inflammatory marker in human
Date of disclosure of the study information 2019/03/06
Last modified on 2019/03/05

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Basic information
Public title Preliminary study on the effect of functional food on Blood inflammatory marker in human
Acronym Preliminary study on the effect of functional food on Blood inflammatory marker in human
Scientific Title Preliminary study on the effect of functional food on Blood inflammatory marker in human
Scientific Title:Acronym Preliminary study on the effect of functional food on Blood inflammatory marker in human
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of functional food on Blood inflammatory marker in human.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood inflammatory marker
Key secondary outcomes

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 Functional food, 4 weeks
Interventions/Control_2 Food without functional food, 4 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Subjects whose are 40 <= years old < 65.
(2) Subjects who can visit hospital on designated day.
(3) Subject who is able to give written informed consent before the study.
Key exclusion criteria (1) Subjects whose systolic blood pressure is less than 90mmHg
(2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
(3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study
(4) Males whose blood was collected more than 400 mL within the last 12 weeks
(5) Females whose blood was collected more than 400 mL within the last 16 weeks
(6) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added
(7) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added
(8) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
(9) Subjects who drink alcohol a lot
(10) Subjects who have a habit of smoking
(11) Subjects who are with treatment
(12) Subjects who constantly use drug medicine
(13) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Nonaka
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0587
Email Yuji_Nonaka@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takatsugu Tsuchiya
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0567
Homepage URL
Email Takatsugu_Tsuchiya@suntory.co.jp

Sponsor
Institute SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department

Funding Source
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 03 Month 06 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 07 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
2019 Year 03 Month 05 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041116

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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