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 triglyceride level of subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

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

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
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 has serious medical history or who had digestive tract resection surgery. 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 the test food or high fat meal and have extreme lactose intolerance or diarrhea. 4)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. 5) Heavy use of alcohol or excessive smokers 6) Subjects who is considered to be inappropriate to attend the present study by the investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	Hideaki Hoshino
Organization	Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name	General Medicine Clinical Departments Internal Medicine Respiratory Medicine Allergy
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL	011-868-2711
Email	shiroishi@jikkai.or.jp

Public contact
Name of contact person	Kosuke Suzuki
Organization	Medical Corporation Jikokai
Division name	Clinical Trial Division
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL	011-868-2711
Homepage URL
Email	suzuki-jikoukai@e-mail.jp

Sponsor
Institute	FANCL Corporation Research Institute
Institute
Department

Funding Source
Organization	None
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	医療法人社団 慈昂会 白石内科クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 11 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	2018 Year 05 Month 29 Day
Last modified on	2018 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037354