UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022103 |
|---|---|
| Receipt number | R000025477 |
| Scientific Title | Postprandial vascular inflammation after high-fat meal in healthy subjects |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/04/27 15:02:15 |
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Basic information
Public title
Postprandial vascular inflammation after high-fat meal in healthy subjects
Acronym
Postprandial vascular inflammation after high-fat meal in healthy subjects
Scientific Title
Postprandial vascular inflammation after high-fat meal in healthy subjects
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Mariko Tani |
Organization
Graduate School of Medical and Dental Sciences
, Tokyo Medical and Dental University
Division name
Department of Cardiovascular Nutrition and Metabolism
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-4617
tanimari.cvnm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Tani |
Organization
Graduate School of Medical and Dental Sciences , Tokyo Medical and Dental University
Division name
Department of Cardiovascular Nutrition and Metabolism
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-4617
Homepage URL
tanimari.cvnm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025477
