UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Slightly higher fasting serum triglyceride level (from 120 to no more than 200 mg/dL)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of a complex food on the suppression of the elevation of postprandial serum triglyceride as a primary endpoint.
To evaluate the safety of the complex food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Time course of serum triglyceride level and AUC 0-6 for actual measured values as well as amount of changed values after intake of dietary fat.

Key secondary outcomes

Time course of serum RLP-cholesterol level and AUC 0-6 for actual measured values and amount of changed values after intake of dietary fat.
Assessment of safety(subjective and objective symptoms and blood biochemistry).

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

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

Interventions/Control_2

single ingestion of a test food - washout period (6 days or more) - single ingestion of a 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)Healthy Japanese males and females from 20 to 64 years of age when consented.
(2)Subjects whose fasting serum triglyceride levels are less than 150 mg/dL. Most of them desirably have triglyceride level of 120 - 149 mg/dL.
(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 appendicectomy)
(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 diet (shift worker, night-shift worker, etc.)
(13)Subjects judged as unsuitable for this study by the investigator for other reasons.

Target sample size

32

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiko Takano

Organization

Medical Corporation Hokubukai

Division name

Utsukushigaoka Hospital

Zip code

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

TEL

011-882-0111

Email

takano@ughp-cpc.jp

Name of contact person

1st name
Middle name
Last name	Ryota Wakimoto

Organization

Medical Corporation Hokubukai

Division name

Utsukushigaoka Hospital

Zip code

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

TEL

011-882-0111

Homepage URL

Email

wakimoto@ughp-cpc.jp

Institute

Medical Corporation Hokubukai Utsukushigaoka 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

Date of disclosure of the study information

2018

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

In the stratified group, there was a tendency to suppress the elevation of postprandial serum triglyceride by ingestion of the complex food.

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

01

Month

11

Day

Date of IRB

Anticipated trial start date

2017

Year

02

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

02

Month

14

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=R000029452