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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042474
Receipt No. 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 2021/08/26

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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
Post-prandial Blood glucose levels
Post-prandial Blood glucose 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
Email 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
Email drc_shokuhin@drc-web.co.jp

Sponsor
Institute Medicial Corporation Kenshokai, Fukushima Healthcare Center
Institute
Department

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
Email 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
2021 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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