UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of the intake of a resistant glucan (water-soluble dietary fiber) on postprandial increase in Serum Triglyceride:randomized,placebo-controlled,double blind cross-over trial
Title of the study (Brief title)	A study for evaluating the effect of the intake of a resistant glucan (water-soluble dietary fiber) on postprandial increase in Serum Triglyceride
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of a resistant glucan (water-soluble dietary fiber) on postprandial increase in Serum Triglyceride
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	area under the curve for serum triglyceride levels
Key secondary outcomes	fasting triglyceride level, triglyceride level of 2,3,4 and 6hours after the high-fat meal ingestion, Remnant-like particle cholesterol

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	Cross-over
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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	intake of a test food with resistant glucan (single ingestion) - washout period - placebo food without resistant glucan (single ingestion)
Interventions/Control_2	intake of a placebo food without resistant glucan (single ingestion) - washout period - test food with resistant glucan (single ingestion)
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) Males and females from 20 to 64 years of age 2) fasting triglyceride levels are ranged from 120 mg/dL to 199 mg/dL
Key exclusion criteria	(1) Subjects who routinely use food rich in dietary fiber (2) Subjects routinely taking medicine or health food which may influence lipid metabolism (3) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (4) Subjects having possibilities for emerging allergy related to the study (5) Subjects who are under medication or having a history of serious diseases for which medication was required (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) 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 (8) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	100

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	Chiharu Goto
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	c.goto@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 09 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 27 Day
Anticipated trial start date	2015 Year 09 Month 15 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 09 Month 14 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021970