UMIN-CTR Clinical Trial

Public title

Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism

Acronym

Investigation of the effectiveness of resistant maltodextrin on glycometabolism

Scientific Title

Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism

Scientific Title:Acronym

Investigation of the effectiveness of resistant maltodextrin on glycometabolism

Region

Japan

Condition

Male and female who are aged 20 years and older and who have high HbA1c levels

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the improvement of glycometabolism such as HbA1c and fasting blood glucose levels when subjects ingest resistant maltodextrin for 24 weeks

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(1)Efficacy: HbA1c
(2)Safety: The incidence of side effects

Key secondary outcomes

(1)Efficacy: OGTT, GA, 1.5-AG, GLP-1, intestinal flora
(2)Safety: The incidence of adverse events

Study type

Interventional

Basic design

Parallel

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

Treatment

Type of intervention

Food

Interventions/Control_1

Intake 2 packages of resistant maltodextrin a day for 24 weeks

Interventions/Control_2

Intake 2 packages of dextrin a day for 24 weeks

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Males and females aged 20 and older.
(2) Subjects whose HbA1c levels are equal to or higher than 6.0%.
(3) Subjects who receive explanation for this study and voluntary give written informed consent.

Key exclusion criteria

(1) Subjects who are diagnosed as diabetes and receiving treatment.
(2) Subjects who constantly take oral medicines, functional foods and/or supplements that have a possibility to affect the test results.
(3) Females who are pregnant or lactating, and females who have possibility of pregnancy.
(4) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test.
(5) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test.
(6) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test.
(7) Males who were collected blood and blood components more than 1200 ml within 12 months prior to the test when planned blood sampling amount of this test is added.
(8) Females who were collected blood and blood components more than 800 ml within 12 months prior to the test when planned blood sampling amount of this test is added.
(9) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test.
(10) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day).
(11) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts.
(12) Subjects who falls under any of the following criteria.
(a) Subjects who have heart disease, liver disease, or kidney disease (including the complication of other diseases).
(b) Subjects who have medical history of cardiovascular diseases.
(c) Subjects who are allergic to the test foods.
(13) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Katsuhisa Sakano

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5927-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name
Middle name
Last name	Kazuyoshi shibata

Organization

CPCC Company Limited

Division name

Plan Sales Department

Zip code

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5927-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Matsutani Chemical Industry Co., 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

2016

Year

09

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

2016

Year

07

Month

21

Day

Date of IRB

Anticipated trial start date

2016

Year

09

Month

13

Day

Last follow-up date

2017

Year

08

Month

24

Day

Date of closure to data entry

2017

Year

09

Month

26

Day

Date trial data considered complete

2017

Year

10

Month

11

Day

Date analysis concluded

2017

Year

11

Month

28

Day

Other related information

Registered date

2016

Year

09

Month

07

Day

Last modified on

2018

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027589