UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy test of KTT002
Title of the study (Brief title)	The efficacy test of KTT002
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of KTT002 for physical conditions and symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire about physical conditions and symptoms before and after 8wks sample ingestion.
Key secondary outcomes

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
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of active three times a day for 8 weeks.
Interventions/Control_2	Ingestion of control three times a day for 8 weeks.
Interventions/Control_3	Observation group
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy subjects giving written informed consent.
Key exclusion criteria	1) Subjects with a history of allergy or might be liable to allergy related to the study 2) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system 3) The pregnant and subjects who hope to get pregnant during the exam period 4) Subjects who are ineligible due to life-style questionnaire 5) Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size	345

Research contact person
Name of lead principal investigator	Shinji Yamamoto
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9416
Email	yamamoto.shinji@kao.com

Public contact
Name of contact person	Kenkichi Yamamoto
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9416
Homepage URL
Email	yamamoto.kenkichi@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035459