UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postprandial vascular inflammation after high-fat meal in healthy subjects
Title of the study (Brief title)	Postprandial vascular inflammation after high-fat meal in healthy subjects
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to investigate the effect of high-fat diet on postprandial vascular inflammation.
Basic objectives2	Others
Basic objectives -Others	To evaluate the vascular inflammatory markers in the fasting and the postprandial state.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	After an overnight fast, a fasting venous blood sample is drawn. 20 healthy adults intake the high-fat diet containing 28.5 g of fat. Blood samples are obtained at 1, 2, 4 h after fat intake. The vascular inflammatory parameters for plasma lipid, lipoprotein, apolipoprotein, C3, C5a, inflammatory markers, leukocyte numbers are measured in the fasting and the postprandial state.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	After an overnight fast, a fasting venous blood sample is drawn. 20 healthy adults intake the high-fat diet containing 28.5 g of fat. Blood samples are obtained at 1, 2, 4 h after fat intake. The vascular inflammatory parameters for plasma lipid, lipoprotein, apolipoprotein, C3, C5a, inflammatory markers, leukocyte numbers are measured in the fasting and the postprandial state.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adults were recruited by public offering through a recruitment flyer or emails.
Key exclusion criteria	- Smokers - Taking medications and supplements known to affect plasma lipids - No overnight-fasting - Food allergy for wheat, egg, peanuts, orange, walnuts, soy beans, apple, and peach
Target sample size	20

Research contact person
Name of lead principal investigator	Mariko Tani
Organization	Graduate School of Medical and Dental Sciences , Tokyo Medical and Dental University
Division name	Department of Cardiovascular Nutrition and Metabolism
Address	Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL	03-5803-4617
Email	tanimari.cvnm@tmd.ac.jp

Public contact
Name of contact person	Mariko Tani
Organization	Graduate School of Medical and Dental Sciences , Tokyo Medical and Dental University
Division name	Department of Cardiovascular Nutrition and Metabolism
Address	Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL	03-5803-4617
Homepage URL
Email	tanimari.cvnm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 27 Day
Anticipated trial start date	2016 Year 07 Month 01 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	2016 Year 04 Month 27 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025477