UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036737
Receipt number R000041856
Scientific Title Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study-
Date of disclosure of the study information 2019/05/16
Last modified on 2019/11/05 12:04:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study-

Acronym

Suppressive effect of combination of test food on the postprandial triglyceride level

Scientific Title

Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study-

Scientific Title:Acronym

Suppressive effect of combination of test food on the postprandial triglyceride level

Region

Japan


Condition

Condition

Adult men and women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of test food on the postprandial triglyceride level of subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Area under the curve for postprandial serum triglyceride level

Key secondary outcomes

Area under the curve for Remnant-like particle cholesterol, and serum triglyceride levels and Remnant-like particle cholesterol of before, 2, 3, 4 and 6 hours after high fat meal ingestion.


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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food (single ingestion) - washout period - intake of placebo (single ingestion).

Interventions/Control_2

Intake of placebo (single ingestion) - washout period - intake of test food (single ingestion).

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Males and females 20 to 64 years of age.
2) Subjects whose fasting serum triglyceride levels are less than 200 mg/dL.

Key exclusion criteria

1) Subjects who has serious medical history or who had digestive tract resection surgery.
2) Subjects who routinely use medicine, supplements, FOSHU and/or health food which affect to result of the study.
3) Subjects who have allergy to the test food or high fat meal and have extreme lactose intolerance or diarrhea.
4) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
5) Heavy use of alcohol or excessive smokers
6) Subjects who is considered to be inappropriate to attend the present study by the investigator.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hideaki
Middle name
Last name Hoshino

Organization

Medical Corporation Jikokai Shiroishi Internal Medicine Clinic

Division name

General Medicine Clinical Departments Internal Medicine Respiratory Medicine Allergy

Zip code

003-0011

Address

7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan

TEL

011-868-2711

Email

shiroishi@jikkai.or.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Suzuki

Organization

Medical Corporation Jikokai

Division name

Clinical Trial Division

Zip code

003-0011

Address

7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan

TEL

011-868-2711

Homepage URL


Email

suzuki-jikoukai@e-mail.jp


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Institutional Review Board

Address

Ito-Yokado Fukuzumi 5F, 1-2-5 Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan

Tel

011-836-3531

Email

fukui@mediks.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

医療法人社団 慈昂会 白石内科クリニック


Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

60

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

2019 Year 05 Month 13 Day

Date of IRB

2019 Year 05 Month 13 Day

Anticipated trial start date

2019 Year 06 Month 06 Day

Last follow-up date

2019 Year 06 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 05 Month 14 Day

Last modified on

2019 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name