UMIN-CTR Clinical Trial

Basic information
Public title	The study of a long-term ingestion of a plant-deriverd processed product
Acronym	The study of a plant-derivered processed product
Scientific Title	The study of a long-term ingestion of a plant-deriverd processed product
Scientific Title:Acronym	The study of a plant-derivered processed product
Region	Japan

Condition
Condition	Nothing(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of a long-term ingestion of a plant-derived processed product
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	Body weight, Body Mass Index

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	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Control food (product code;T-001) 1-year repeated consumption Dose of 1 serving per day Body weight measurement every 1 or 2 month
Interventions/Control_2	Test food (product code;S-001) 1-year repeated consumption Dose of 1 serving per day Body weight measurement every 1 or 2 month
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1, healthy adult aged from 20 to 60 2, get informed consent in written
Key exclusion criteria	1, difficult o participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions 2, surgery for a disease or an injury 2 months prior to the study 3, treatment with medicine to improve glucose metabolism, fat metabolism, or blood presser 4, cat't maintain his/her habitual consumption of foods with health claim, supplement use or physical activity throughout the study periods including pre-treatment period. 5, experienced unpleasant feeling during blood drawing. 6, use of pacemaker, or metallic allergy and skin disease 7, weight change of 3kg and more within 1 month before the study 8, shift worker 9, allergies against any constituents in the test diet 10, potential to entry test of same test diet 11, disagree with explanation for study 12, judged to be inappropriate as subject by physician in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Saito
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
TEL	03-5630-7456
Email	saito.shinichiro@kao.com

Public contact
Name of contact person	1st name Nami Middle name Last name Yamanaka
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
TEL	03-5630-7456
Homepage URL
Email	yamanaka.nami2@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
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	Kao Corporation
Address	2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
Tel	+81-3-5630-9220
Email	uesaka.toshio@kao.com

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	2018 Year 04 Month 19 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	68
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	2018 Year 03 Month 15 Day
Date of IRB	2018 Year 03 Month 15 Day
Anticipated trial start date	2018 Year 04 Month 20 Day
Last follow-up date	2019 Year 05 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 19 Day
Last modified on	2019 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035696