UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppressive effect of test food on the postprandial triglyceride level -A randomized, open-label, cross-over study-
Title of the study (Brief title)	Suppressive effect 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 fat meal ingestion.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
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	Ingestion of test food, and then without ingestion of test food after wash out period.
Interventions/Control_2	Without ingestion of test food, 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) Subjects who 20 to 64 years of age. 2) Subjects whose fasting serum triglyceride levels are less than 200 mg/dL. 3) Subjects who can respond to the study schedule including accommodation. 4) Subjects who agree to participate in the study and who can sign, seal and date the consent forms themselves.
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 are judged as unsuitable for the study by the doctor.
Target sample size	50

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, Atsubetsuhigashi 4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	011-898-2151
Email	j.kurokawa@shoureikan.jp

Public contact
Name of contact person	Isao Takehara
Organization	Clinical Support Corporation Limited
Division name	Food Service Division
Address	4-1, South 1 West 8, Chuo-ku, Sapporo, 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	医療法人社団翔嶺館新札幌聖陵ホスピタル（北海道）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 02 Day
Anticipated trial start date	2017 Year 11 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	2017 Year 11 Month 16 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034262