UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of plant-derived ingredients on TTR stability -Exploratory study-
Acronym	An exploratory study to evaluate the effect of plant-derived ingredients on TTR stability
Scientific Title	A study to evaluate the effect of plant-derived ingredients on TTR stability -Exploratory study-
Scientific Title:Acronym	An exploratory study to evaluate the effect of plant-derived ingredients on TTR stability
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploratory verification of transthyretin (TTR) stability in the plasma from healthy Japanese who have taken plant-derived ingredients (300 mg / day, 12 weeks intakes)
Basic objectives2	Others
Basic objectives -Others	Verification of the effect of plant-derived ingredients on TTR stability in plasma
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	TTR stability
Key secondary outcomes	None

Base
Study type	Others,meta-analysis etc

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	35 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Japanese healty females and males older than 35 years 2) Subjects with stable plasma concentrations of the plant-derived ingredients quantitated at 4, 8, and 12 weeks of intakes 3) Subjects with the high averaged concentration of the plant-derived ingredients quantitated at 4, 8, and 12 weeks of intakes 4) Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
Key exclusion criteria	1) Subjects judged as unsuitable for this study by the principal investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Iwao Middle name Last name Funahashi
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	107-6028
Address	1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL	050-3133-6397
Email	Iwao.Funahashi@kaneka.co.jp

Public contact
Name of contact person	1st name Soichi Middle name Last name Yoneda
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Food Test Division
Zip code	103-0027
Address	2-14-1, Nihonbashi, Chuo-ku, Tokyo,
TEL	03-6386-8809
Homepage URL
Email	s-yoneda@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization	KANEKA CORPORATION
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	Institutional Review Board,Kanazawabunko Hospital
Address	Kanagawa Prefecture Yokohama City Kanazawa-ku Kaburiya Higashi 2-chome 6-22
Tel	045-785-3311
Email	watanabe@kanabun-hp.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	金内メディカルクリニック（東京都）、上尾中央第二病院（埼玉県）、笛吹中央病院（山梨県）、武蔵境クリニック（東京都）、久野マインズタワークリニック（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 15 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	10
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 12 Month 11 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2020 Year 05 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 12 Month 13 Day
Last modified on	2020 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044328