UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.
Title of the study (Brief title)	Clinical study for the effect on TG
Region	Japan

Condition
Condition	Healthy subjects with slightly higher fasting serum triglyceride level
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of the complex food on postprandial serum triglyceride(TG) and the safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The differences of serum TG level at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat)
Key secondary outcomes	The differences of serum level of remnant-like lipoprotein cholesterol at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat) Assessment of safety (subjective and objective symptoms and blood chemistry).

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	single ingestion of the placebo food - washout period (6 days or more) - single ingestion of the test food
Interventions/Control_2	single ingestion of the test food - washout period (6 days or more) - single ingestion of the placebo food
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)Japanese males and females from 20 to 64 years of age when consented. (2)Healthy subjects whose fasting serum TG levels is slightly high at pre-, 1st and 2nd screenings and whose time courses of serum TG after loading dietary food resemble each other at 1st and 2nd screening. (3)Subjects available at every designated visit. (4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria	(1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. (2) Subjects with a surgical history of digestive system (except appendicectom). (3) Subjects with a history of a previous drug or food allergy. (4) Subjects currently under treatment with chronic diseases. (5) Subjects who are pregnant or intend to become pregnant during the study or are lactating. (6) Subjects who are lactose intolerant or sensitive to fatty diet to show gastrointestinal symptoms. (7) Subjects who take excessive alcohol (equivalent to 540 mL of Japanese sake or more) for 5 days or more per week. (8) Subjects who take drugs or supplements which claim the suppressive absorption of sugar or lipid or reduction of triglyceride, etc. (9) Subjects who participate in other clinical trial. (10) Subjects who have a history of feeling ill or unwell during or after blood drawing. (11) Subjects who have donated over 200 mL of blood within the last one month prior to this study or expect to donate the same during the study. (12) Subjects with extremely irregular dietary life (shift worker, night- shift worker, etc.) (13) Subjects who had excessive eating and/or drinking during 3 days prior to each screening or prior to intervention period I or II. (14) Subjects who fasted repeatedly during 3 days prior to each screening or prior to intervention period I or II. (15) Subject who had excessive exercise than usual during 3 days prior to each screening or prior to intervention period I or II. (16) Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	Jyoji Kurokawa
Organization	Iryouhoujinsyadan Shoureikan
Division name	Shinsapporo Seiryou Hospital
Address	2-1-30, Atsubetsuhigashi 4-jo, Atsubetsu-ku Sapporo city, Hokkaido, 004-0004, Japan
TEL	011-898-2151
Email	j.kurokawa@shoureikan.jp

Public contact
Name of contact person	Ryo Kanamori
Organization	Iryouhoujinsyadan Shoureikan
Division name	Shinsapporo Seiryou Hospital
Address	22-1-30, Atsubetsuhigashi 4-jo, Atsubetsu-ku Sapporo city, Hokkaido, 004-0004, Japan
TEL	011-898-2151
Homepage URL
Email	kanamori@hpgr.jp

Sponsor
Institute	Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Institute
Department

Funding Source
Organization	FUJIFILM Corporation
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	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	2018 Year 11 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 02 Day
Anticipated trial start date	2017 Year 10 Month 16 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	Published
URL releasing results	http://www.pieronline.jp/content/article/0386-3603/46120/1993
Results
Other related information

Management information
Registered date	2017 Year 10 Month 10 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033639