UMIN-CTR Clinical Trial

Basic information
Public title	Safety confirmation studies of excessive intake of "food containing indigestible dextrin and young barley leaf" in healthy adult males and females
Acronym	Safety confirmation studies of excessive intake of "food containing indigestible dextrin and young barley leaf" in healthy adult males and females
Scientific Title
Scientific Title:Acronym
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive intake of food containing indigestible dextrin and young barley leaf, 3-fold quantity of recommended daily intake.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/body mass index Doctor's questions Adverse event Evaluate at points of 2week and 4 weeks of ingestion and 2 weeks after the end of ingestion period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of the test product 3 packs per day, 4 weeks.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult males and females from 20 to 64 years of age
Key exclusion criteria	(1) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) Subjects who have participated in other clinical studies (6) Subjects who intend to become pregnant or lactating (7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (8) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Jiro Saito
Organization	Medical Station Clinic
Division name	None
Zip code
Address	3-12-8 Takabann, Meguro-ku, Tokyo, Japan
TEL	03-6452-2712
Email	info@med-station.jp

Public contact
1st name of contact person	1st name Middle name Last name Tamaki Furuhata
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.furuhata@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	non-disclosure
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
Address
Tel
Email

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 10 Month 12 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	2018 Year 09 Month 27 Day
Date of IRB	2018 Year 09 Month 27 Day
Anticipated trial start date	2018 Year 10 Month 15 Day
Last follow-up date	2019 Year 02 Month 28 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 10 Month 12 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039291