UMIN-CTR Clinical Trial

Public title

A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.

Acronym

Clinical study for the effect on TG

Scientific Title

A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.

Scientific Title:Acronym

Clinical study for the effect on TG

Region

Japan

Condition

Healthy subjects with slightly higher fasting serum triglyceride level

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of the complex food on postprandial serum triglyceride(TG) and the safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The differences of serum TG level at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat)

Key secondary outcomes

The differences of serum level of remnant-like lipoprotein cholesterol at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat)
Assessment of safety (subjective and objective symptoms and blood chemistry).

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

Prevention

Type of intervention

Food

Interventions/Control_1

single ingestion of the placebo food - washout period (6 days or more) - single ingestion of the test food

Interventions/Control_2

single ingestion of the test food - washout period (6 days or more) - single ingestion of the placebo food

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Japanese males and females from 20 to 64 years of age when consented.
(2)Healthy subjects whose fasting serum TG levels is slightly high at pre-, 1st and 2nd screenings and whose time courses of serum TG after loading dietary food resemble each other at 1st and 2nd screening.
(3)Subjects available at every designated visit.
(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.

Key exclusion criteria

(1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases.
(2) Subjects with a surgical history of digestive system (except appendicectom).
(3) Subjects with a history of a previous drug or food allergy.
(4) Subjects currently under treatment with chronic diseases.
(5) Subjects who are pregnant or intend to become pregnant during the study or are lactating.
(6) Subjects who are lactose intolerant or sensitive to fatty diet to show gastrointestinal symptoms.
(7) Subjects who take excessive alcohol (equivalent to 540 mL of Japanese sake or more) for 5 days or more per week.
(8) Subjects who take drugs or supplements which claim the suppressive absorption of sugar or lipid or reduction of triglyceride, etc.
(9) Subjects who participate in other clinical trial.
(10) Subjects who have a history of feeling ill or unwell during or after blood drawing.
(11) Subjects who have donated over 200 mL of blood within the last one month prior to this study or expect to donate the same during the study.
(12) Subjects with extremely irregular dietary life (shift worker, night- shift worker, etc.)
(13) Subjects who had excessive eating and/or drinking during 3 days prior to each screening or prior to intervention period I or II.
(14) Subjects who fasted repeatedly during 3 days prior to each screening or prior to intervention period I or II.
(15) Subject who had excessive exercise than usual during 3 days prior to each screening or prior to intervention period I or II.
(16) Subjects judged as unsuitable for this study by the investigator for other reasons.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Jyoji Kurokawa

Organization

Iryouhoujinsyadan Shoureikan

Division name

Shinsapporo Seiryou Hospital

Zip code

Address

2-1-30, Atsubetsuhigashi 4-jo, Atsubetsu-ku Sapporo city, Hokkaido, 004-0004, Japan

TEL

011-898-2151

Email

j.kurokawa@shoureikan.jp

Name of contact person

1st name
Middle name
Last name	Ryo Kanamori

Organization

Iryouhoujinsyadan Shoureikan

Division name

Shinsapporo Seiryou Hospital

Zip code

Address

22-1-30, Atsubetsuhigashi 4-jo, Atsubetsu-ku Sapporo city, Hokkaido, 004-0004, Japan

TEL

011-898-2151

Homepage URL

Email

kanamori@hpgr.jp

Institute

Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital

Institute

Department

Personal name

Organization

FUJIFILM Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団翔嶺館新札幌聖陵ホスピタル（北海道）

Date of disclosure of the study information

2018

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/46120/1993

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

02

Day

Date of IRB

Anticipated trial start date

2017

Year

10

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

10

Day

Last modified on

2019

Year

03

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033639