UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042474 |
|---|---|
| Receipt number | R000048488 |
| Scientific Title | Inhibition of post-meal increase in blood triglyceride levels due to food intake |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2024/03/22 16:03:59 |
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Basic information
Public title
Inhibition of post-meal increase in blood triglyceride levels due to food intake
Acronym
Postprandial blood triglyceride suppression by food intake
Scientific Title
Inhibition of post-meal increase in blood triglyceride levels due to food intake
Scientific Title:Acronym
Postprandial blood triglyceride suppression by food intake
Region
| Japan |
Condition
Condition
healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the inhibition of the rise in post-meal triglyceride levels due to food consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
post-meal triglyceride levels
Key secondary outcomes
Post-prandial triglyceride AUC
Post-prandial RLP-Cholesterol levels
Post-prandial RLP-Cholesterol AUC
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of foods containing plant extracts
Interventions/Control_2
Single intake of placebo foods
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Fasting blood triglycerides at the pre-inspection were high to slightly higher than normal
2)Those who can give their consent to participate in the study voluntarily in writing
Key exclusion criteria
(1) A person who has been determined to have dyslipidemia and is currently being treated for
(2) A person currently receiving medication for dyslipidemia or hypertension
(3) Any person who consumes any of the ingredient foods or health foods involved in this test food
(4) Regularly taking supplements related to cholesterol, blood pressure, blood lipids, and blood sugar levels.
someone who is a follower of
(5) Carbohydrate metabolism, lipid metabolism, liver function, kidney function, cardiac, cardiovascular, respiratory, endocrine, and immune systems.
A person with a serious disease of the system or nervous system or a mental illness. and those who have a history of such diseases.
person
(6) A patient with a history of abnormalities in clinical laboratory values, and who has been judged to have a problem participating in the study.
(7) Have a medical condition that is being treated or have a history of serious illness that requires medication
person
(8) Any person with a risk of developing an allergy in connection with the test
(9) Those who are judged to be unsuitable as subjects based on the results of the lifestyle questionnaire.
(10) who are participating in another clinical study at the time of the start of this study.
(11) A person who is pregnant or plans to become pregnant or breastfeeding during the study period.
(12) A person who is deemed unsuitable to participate in the study by the principal investigator (or the study director)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medicial Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
Tamagawa 2-12-16, Fukushima-ku, Osaka-shi, Osaka, 553-0004, Japan
TEL
06-6441-6848
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Furusyo |
Organization
DRC Co., Ltd
Division name
Food Human Testing Division
Zip code
530-0044
Address
5F, 9th Tabuchi Building, Higashitenma 2-10-31, Kita-Ku, Osaka city
TEL
06-6882-1130
Homepage URL
drc_shokuhin@drc-web.co.jp
Sponsor or person
Institute
Medicial Corporation Kenshokai, Fukushima Healthcare Center
Institute
Department
Personal name
Funding Source
Organization
Iwase Cosfa 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
Brain Care Clinic Ethics Review Committee
Address
Samon-Cho13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel
03-3351-3386
drc_shokuhin@drc-web.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
| 2020 | Year | 11 | 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
30
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048488
