UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on the relationship between lifestyle and health indicators (SWE-2022-01)
Acronym	Observational study on the relationship between lifestyle and health indicators
Scientific Title	Observational study on the relationship between lifestyle and health indicators (SWE-2022-01)
Scientific Title:Acronym	Observational study on the relationship between lifestyle and health indicators
Region	Japan

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

Objectives
Narrative objectives1	Examine the relationship between various lifestyle and health indicators.
Basic objectives2	Others
Basic objectives -Others	Examine the relationship between various lifestyle and health indicators.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Various lifestyle and health indicators.
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	30 years-old <=
Age-upper limit	64 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Men and women who are between 30 and 64 years of age. (2) Persons who fully understand the purpose and content of this study and have given their written consent.
Key exclusion criteria	(1) Those who have taken antibiotics within 3 months prior to the start of this study (2) Those who have food allergies (3) Those with dietary restrictions such as carbohydrate restriction, vegetarianism, etc. (4) Those who have an extremely irregular diet (5) Persons who have experienced illness or physical discomfort due to blood sampling in the past (6) Other subjects deemed inappropriate for the study by the principal investigator or subinvestigator.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Obata
Organization	Suntory Wellness Limited
Division name	Institute for Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0568
Email	Hidenori_Obata@suntory.co.jp

Public contact
Name of contact person	1st name Toshiaki Middle name Last name Sueyasu
Organization	Suntory Wellness Limited
Division name	Institute for Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0676
Homepage URL
Email	Toshiaki_Sueyasu@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

Funding Source
Organization	Suntory Wellness Limited
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	Miura Clinic, Medical Corporation Kanonkai
Address	1-7-17, Higashitenma, Kitaku, Osaka city, Osaka
Tel	06-6135-5200
Email	info@miura-cl.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	2022 Year 07 Month 04 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	2022 Year 06 Month 23 Day
Date of IRB	2022 Year 06 Month 23 Day
Anticipated trial start date	2022 Year 07 Month 05 Day
Last follow-up date	2022 Year 10 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2022 Year 06 Month 24 Day
Last modified on	2022 Year 12 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054884