UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study-
Title of the study (Brief title)	Suppressive effect of combination of test food on the postprandial triglyceride level
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test food on the postprandial blood triglyceride level of subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

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

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 test food, and then ingestion of placebo after wash out period.
Interventions/Control_2	Intake of placebo, and then ingestion of test food after wash out period.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females 20 to 64 years of age 2) Subjects whose fasting serum triglyceride levels are less than 200 mg/dL.
Key exclusion criteria	1) Subjects who routinely use medicine related to lipid metabolism. 2) Subjects who routinely use medicine, supplements, FOSHU, and/or health food which affect to result of the study. 3) Subjects who have allergy to test food and/or high fat meal and have 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 smokers 6) Subjects who have under treatment of chronic disease and routinely uses a medicine.
Target sample size	60

Research contact person
Name of lead principal investigator	Jyouji Kurokawa
Organization	Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name	General Clinical Department
Address	2-1-30, Atsubetsuhigashi4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	011-898-2151
Email	j.kurokawa@shoureikan.jp

Public contact
Name of contact person	Masaya Tsubokawa
Organization	FANCL Corporation
Division name	Research Institute
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3569
Homepage URL
Email	tsubokawa_masaya@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Jpan

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	医療法人社団翔嶺館新札幌聖陵ホスピタル

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 21 Day
Anticipated trial start date	2016 Year 08 Month 19 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	2016 Year 08 Month 18 Day
Last modified on	2016 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027260