UMIN-CTR Clinical Trial

Basic information
Public title	Effects of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study-
Acronym	Effects of a test food on postprandial blood triglyceride level
Scientific Title	Effects of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study-
Scientific Title:Acronym	Effects of a test food on postprandial blood triglyceride level
Region	Japan

Condition
Condition	Healthy adult (who has fasting blood triglyceride level less than 150 mg/dl)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of a test food on postprandial blood triglyceride level after intake of high fat diet
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The differences of serum triglyceride level at sequential sampling time point and AUC (area under the blood concentration - time curve)
Key secondary outcomes	The change of serum RLP cholesterol level at sequential sampling time point and AUC Other lipid metabolism related factors (total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, lipoprotein (a,b), lipoprotein fraction (HDL, LDL, VLDL), phospholipid)

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 (more than 6 days) - single ingestion of the test food
Interventions/Control_2	Single ingestion of the placebo food - washout period (more than 6 days) - single ingestion of the test 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) Healthy subjects aged 20 to 64 years old. (2) Subjects whose fasting serum triglyceride levels are less than 150 mg/dL in medical check up within 1 year (3) Subjects who gave written informed consent.
Key exclusion criteria	a. Subjects who have a history of treatment for malignancy, heart failure and myocardial infarction b. Subjects who have been treated for the following chronic diseases: atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, etc. c. Subjects who frequently use oral medication and/or supplements and/or functional foods (include traditional Chinese medicine) could affect lipid metabolism. d. Subjects who have allergy (medical products, test food related food) e. Subjects who are planned to get pregnant after informed consent for the current study or are pregnant or breastfeeding. f. Subjects who are judged as unsuitable for the study by the physician in charge for other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	R&D department
Zip code	615-8245
Address	1-49, Goryo-Ohara, Nishikyo-ku, Kyoto, Japan
TEL	0753948605
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Yamada
Organization	Pharma Foods International Co., Ltd.
Division name	R&D department
Zip code	615-8245
Address	1-49, Goryo-Ohara, Nishikyo-ku, Kyoto, Japan
TEL	0753948605
Homepage URL
Email	h-yamada@pharmafoods.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	Kotobuki Building.2F, 1-1-3, Yaesu, Chuo-ku, Tokyo, Japan)
Tel	03-5204-0311
Email	jim@medipharma.co.jp

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

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	delay of data analysis
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 06 Month 14 Day
Date of IRB	2019 Year 06 Month 14 Day
Anticipated trial start date	2019 Year 06 Month 19 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 06 Month 25 Day
Last modified on	2022 Year 06 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042302