UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017824
Receipt number R000020645
Scientific Title A study for evaluating the effect of the intake of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride : randomized, placebo-controlled, double blind cross-over trial
Date of disclosure of the study information 2015/06/05
Last modified on 2016/02/18 19:48:06

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Basic information

Public title

A study for evaluating the effect of the intake of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride : randomized, placebo-controlled, double blind cross-over trial

Acronym

A study for evaluating the effect of the intake of indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride

Scientific Title

A study for evaluating the effect of the intake of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride : randomized, placebo-controlled, double blind cross-over trial

Scientific Title:Acronym

A study for evaluating the effect of the intake of indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

area under the curve for serum triglyceride levels

Key secondary outcomes

fasting triglyceride level, triglyceride level of 2,3,4 and 6hours after the high-fat meal ingestion, Remnant-like particle cholesterol


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

test beverage containing of indigestible dextrin

Interventions/Control_2

placebo beverage without indigestible dextrin

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) Males and females from 20 to 64 years of age
(2) fasting triglyceride levels
are ranged from 120 mg/dL to 199 mg/dL

Key exclusion criteria

(1) Subjects who routinely use food containing of indigestible dextrin
(2) Subjects routinely taking medicine or health food which may influence lipid metabolism
(3) Subjects who are under medication or having a history of serious diseases for which medication was required
(4) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(5) Subjects having possibilities for emerging allergy related to the study
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(8) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name 1) Sumio Kondo, 2)Kumie Ito

Organization

1)Medical Corporation Kensho-kai,Fukushima Healthcare Center
2)Yaesu Sakuradori Clinic

Division name

1)Internal Medicine, Department of Neurosurgery 2)Internal Medicine

Zip code


Address

1) 2-12-16 tamagawa,fukushima-ku,osaka-shi,Osaka,553-0004,Japan 2)1-6-6yaesu,chuo-ku,Tokyo,Japan

TEL

06-6441-6848.03-6214-1285

Email

ko283434@ares.eonet.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chiharu Goto

Organization

TTC Co.,Ltd

Division name

Clinical Research Planning Department

Zip code


Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

c.goto@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Coca Cola (Japan) 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


Address


Tel


Email



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

2015 Year 06 Month 05 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


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

2015 Year 05 Month 28 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Principal investigator's E-mail adress 2):info@y-sakuradoori.jp


Management information

Registered date

2015 Year 06 Month 05 Day

Last modified on

2016 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020645


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name