UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions)
Acronym	Elucidation of the relationship between food intake and levels of various health diagnostic markers
Scientific Title	Elucidation of the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions)
Scientific Title:Acronym	Elucidation of the relationship between food intake and levels of various health diagnostic markers
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions).
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationships between dietary intake determined by a food frequency questionnaire and internal levels of food ingredients and levels of measurements and biomarkers (e.g., lipopolysaccharide-binding protein (LBP)) related to health condition. (The data obtained at an annual health check-up between 2015 to 2021 for local residents will be analyzed.)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)20 years of age or older, living in the Iwaki area of Hirosaki City, Aomori Prefecture, Japan. (2) Those who have fully understood the purpose and content of this study and have agreed to participate in.
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Shigeyuki Middle name Last name Nakaji
Organization	Hirosaki University
Division name	Innovation Center for Health Promotion
Zip code	036-8562
Address	5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL	0172-39-5041
Email	nakaji@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Suganuma
Organization	KAGOME CO., LTD.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama Nasushiobara, Tochigi 329-2762, Japan
TEL	0287-36-2935
Homepage URL
Email	Hiroyuki_Suganuma@kagome.co.jp

Sponsor
Institute	KAGOME CO., LTD.
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hirosaki University
Name of secondary funder(s)	Hirosaki University

IRB Contact (For public release)
Organization	Ethics committee of Hirosaki University Grauate School of Medicine
Address	5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan
Tel	0172-39-5043
Email	rinri@hirosaki-u.ac.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	弘前大学院医学研究科附属健康未来イノベーションセンター（青森県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 20 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	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 04 Month 09 Day
Anticipated trial start date	2015 Year 05 Month 30 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The data obtained at an annual health check-up between 2015 to 2021 for the residents of Iwaki area of Hirosaki city, Aomori prefecture will be analyzed to clarify the relationships between food intakes and health conditions.

Management information
Registered date	2021 Year 05 Month 11 Day
Last modified on	2021 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050446