UMIN-CTR Clinical Trial

Basic information
Public title	Effect 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	Effect 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 difference of serum triglyceride level at sequential sampling time points and AUC (area under the blood concentration - time curve) (before ingestion of high fat diet, and 2, 3, 4, 6 hours after ingestion of a high fat)
Key secondary outcomes	The difference of serum RLP cholesterol level at sequential sampling time points and AUC Other lipid metabolism related factors (Total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, beta lipoprotein, lipoprotein fraction, phospholipid) (before ingestion of high fat diet and 2, 3, 4, 6 hours after ingestion of a high fat) Height, body weight, BMI(before ingestion of high fat diet)

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 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) Healthy subjects aged 20 to 65 years old. (2) Subjects whose fasting serum triglyceride levels are less than 150 mg/dL. (3) Subjects giving written informed consent.
Key exclusion criteria	a. Subjects who have a history of treatment for malignancy, heart failure and myocardial infarction b. Subjects who are being treated for the following chronic diseases; atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases c c. Frequent users of medicine (includes TCM) and/or supplements and/or health foods that could affect lipid metabolism. d. Subjects who have allergy (medical products, test food related food) e. Subjects who are pregnant or breastfeeding or planning to get pregnant during the study f. Subjects who are judged as unsuitable for the study by the physician in change due to other reason.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yamatsu Middle name Last name Atsushi
Organization	Pharma Foods International Co., Ltd.
Division name	R&D department
Zip code	615-8245
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto 615-8245, Japan
TEL	075-748-9829
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 615-8245, Japan
TEL	075-748-9829
Homepage URL
Email	h-yamada@pharmafoods.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization	Mitsui Sugar Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the ethics committees of Yoga Allergy Clinic
Address	4-32-16, Yoga, Setagaya-ku, Tokyo, 158-0097, Japan
Tel	03-5491-4478
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	2021 Year 06 Month 30 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	85
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	2021 Year 05 Month 28 Day
Date of IRB	2021 Year 06 Month 11 Day
Anticipated trial start date	2021 Year 06 Month 30 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 29 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=R000051046