UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2019 Year 03 Month 04 Day
Date of IRB	2019 Year 03 Month 04 Day
Anticipated trial start date	2019 Year 03 Month 07 Day
Last follow-up date	2019 Year 09 Month 30 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 03 Month 05 Day
Last modified on	2020 Year 09 Month 28 Day

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