UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
Title of the study (Brief title)	Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
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 long-term consumption of food containing resistant glucan (water-soluble dietary fiber), quantity of recommended daily intake.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the test product for 12 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy adult males and females from 20 to 64 years of age (2) Subjects falling under any of the following A. triglyceride levels are ranged from 120 mg/dL to 199 mg/dL (10 or more subjects) B. blood fasting glucose levels are ranged from 110 mg/dL to 125 mg/dL (10 or more subjects) C. triglyceride levels are less than 120 mg/dL and blood fasting glucose levels are less than 110 mg/dL (10 or more subjects)
Key exclusion criteria	(1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring treatment 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 study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (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	30

Research contact person
Name of lead principal investigator	Toshihiro Yamamoto
Organization	NIHON SHOKUHIN KAKO CO., LTD.
Division name	RESEARCH INSTITUTE
Address	30 TAJIMA FUJI, SHIZUOKA
TEL	0545-53-5995
Email	toshihiro.yamamoto@nisshoku.co.jp

Public contact
Name of contact person	Yuki Kitahara
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	y.kitahara@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	NIHON SHOKUHIN KAKO CO., LTD.
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 23 Day
Anticipated trial start date	2015 Year 08 Month 22 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	2015 Year 08 Month 03 Day
Last modified on	2016 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021417