UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study-
Title of the study (Brief title)	Suppressive effect of functional rice on the postprandial serum triglyceride level
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to verify the suppressive effect of functional rice on postprandial serum triglyceride level
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve (AUC) of postprandial serum triglyceride level
Key secondary outcomes	Postprandial serum triglyceride levels and remnant like lipoprotein particle cholesterol levels and their AUC

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of function rice- wash out- intake of control (Placebo) rice
Interventions/Control_2	Intake of control (placebo) rice- wash out- intake of function rice
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	1) Subjects who have ability to conscent 2)Subjects aged from 20 to less than or equal to 64years old 3)Subjects whose fasting serum triglyceride levels are less than 200 mg/dL
Key exclusion criteria	1) Subjects who have history of serious disease or resection of their gastrointestinal tract. 2) Subjects who routinely use medicine, FOSHU, and/or health food. 3) Subjects who have allergy to test food and/or high fat meal and extreme lactose intolerance or diarrhea. 4) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 5) Heavy user of alcohol or excessive smoker 6) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuhiko Takano
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name	Clinical pharmacology center
Address	61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
TEL	001-882-0111
Email	takano@ughp-cpc.jp

Public contact
Name of contact person	Isao Takehara
Organization	Clinical Support Corporation
Division name	Food Division
Address	Minami 1 jou Nishi, Chuo-ku, Sapporo city, Hokkaido, Japan
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	医療法人北武会　美しが丘病院

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 02 Month 10 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	2017 Year 02 Month 08 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029853