UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on nutrient excretion
Acronym	Clinical study on nutrient excretion
Scientific Title	Clinical study on nutrient excretion
Scientific Title:Acronym	Clinical study on nutrient excretion
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the relationship among nutrients and background parameters of subject.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship among measurement parameters
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Japanese aged from 20 to 70 years old
Key exclusion criteria	1. Subjects who have serious medical history and surgical history of resection of the gastrointestinal tract 2. Subjects who are not pregnant and breast feeding 3. Subjects who consume alcohol or excessive smoking 4. Subjects who are judged as unsuitable for the study by the principle doctor for other reason.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Takehara
Organization	Clinical Support Corporation Limited
Division name	PI/Food Service division
Zip code	150-0021
Address	4-1South 1 West 8, Chuo-ku, Sapporo city, Hokkaido, Japan
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital Institutional Review Board
Address	61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel	011-882-0111
Email	wakimoto@ughp-cpc.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	医療法人北武会　美しが丘病院

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 13 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	316
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 01 Month 31 Day
Date of IRB	2019 Year 02 Month 07 Day
Anticipated trial start date	2019 Year 02 Month 21 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 02 Month 12 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040836