UMIN-CTR Clinical Trial

Public title

Study of Effect of Bevarage Containing Resistant Maltodextrin on Postprandial blood glucose level -a randomized, double blaind placebo-controlled, cross-over study-

Acronym

Study of Effect of Bevarage Containing Resistant Maltodextrin on Postprandial blood glucose level

Scientific Title

Study of Effect of Bevarage Containing Resistant Maltodextrin on Postprandial blood glucose level -a randomized, double blaind placebo-controlled, cross-over study-

Scientific Title:Acronym

Study of Effect of Bevarage Containing Resistant Maltodextrin on Postprandial blood glucose level

Region

Japan

Condition

Healty adult (subjects who is Impaired Glucose Tolerance and/or who is Impaired fasting glycaemia)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of beverage containing resistant maltodextrin on postprandial blood glucose level

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

postprandial blood glucose level

Key secondary outcomes

postprandial blood insulin level

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

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

beverage containing resistant maltodextrin, 1 per serving

Interventions/Control_2

beverage not containing resistant maltodextrin, 1 per serving

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) males and females aged 20 to 64 years old.
(2)Subjects whose fasting blood glucose levels are from 110 mg/dL to 125 mg/dL or whose OGTT test (after 2hours) blood glucose levels are from 140mg/dL to 199mg/dL.
(3)Not heavy alcoholic drinker. (Subjects who can stop drinking from 2 days before each measurement.)
(4)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

(1)Subjects who use oral medication affecting blood glucose.
(2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting blood glucose.
(3)Subjects who have declared allergic reaction to ingredients contained in test diets.
(4)Subjects who need medical treatment for diabetes.
(5)Subjects who contract or are under treatment or are medical history for serious diseases (e.g.,liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(6)Subjects who have a chronic disease and use medicines continuously.
(7)Subjects who have a history of digestive disease affecting digestion and absorption.
(8)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator.
(9)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(10)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
(11)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(12)Subjects who are planning to participate in other clinical studies.
(13)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
(14)Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Haruhi Sugimura

Organization

Medical Corporation Shinkokai C'est La Vie Shinbashi Clinic

Division name

Medical office

Zip code

Address

2-39-3 Nisishimbashi,Minato-ku,Tokyo

TEL

03-5408-8671

Email

h-sughimura@shinkokai.jp

Name of contact person

1st name
Middle name
Last name	Komori Yoshika

Organization

KSO Corporation

Division name

Sales department

Zip code

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-5408-8671

Homepage URL

Email

yoshi@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

ASAHI BREWERIES, LTD.

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

2015

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

05

Month

25

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

25

Day

Last modified on

2016

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020938