UMIN-CTR Clinical Trial

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

healthy participants

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

post-meal triglyceride levels

Key secondary outcomes

Post-prandial triglyceride AUC
Post-prandial RLP-Cholesterol levels
Post-prandial RLP-Cholesterol AUC

Study type

Interventional

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

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

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

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

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

Institute

Medicial Corporation Kenshokai, Fukushima Healthcare Center

Institute

Department

Personal name

Organization

Iwase Cosfa Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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