UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035156
Receipt number R000040069
Scientific Title The acute effects of inulin on postprandial glycemic.
Date of disclosure of the study information 2019/12/06
Last modified on 2019/10/03 16:17:50

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Basic information

Public title

The acute effects of inulin on postprandial glycemic.

Acronym

Inulin clinical trial

Scientific Title

The acute effects of inulin on postprandial glycemic.

Scientific Title:Acronym

Inulin clinical trial

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the postprandial glycemic in inulin intake.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

postprandial glycemia

Key secondary outcomes



Base

Study type

Interventional


Study design

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



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

To intake supplements containing Inulin 3 package / time.

Interventions/Control_2

To intake placebo 3 package / time

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Persons who is generally judged as healthy

Key exclusion criteria

(1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) Persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) Persons who have been treated their illness or prevention in a clinic at their informed consent
(5) Persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) Persons with the medical histories of alcoholism or drug dependence
(7) Persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) Persons who will not be judged suitable to the participants by the

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Koichiro
Middle name
Last name Ohnuki

Organization

Kindai University

Division name

Faculty of humanity-oriented science and engineering

Zip code

820-0011

Address

11-6, Kayanomori, Iizuka-shi, Fukuoka

TEL

0948-22-5655

Email

ohnuki@fuk.kindai.ac.jp


Public contact

Name of contact person

1st name Koichiro
Middle name
Last name Ohnuki

Organization

Kindai University

Division name

Faculty of humanity-oriented science and engineering

Zip code

820-0011

Address

11-6, Kayanomori, Iizuka-shi, Fukuoka

TEL

0948-22-5655

Homepage URL


Email

ohnuki@fuk.kindai.ac.jp


Sponsor or person

Institute

Faculty of Agriculture, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Fuji Nihon Seito 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

Ethics Committee,Faculty of humanity-oriented science and engineering,Kindai University

Address

11-6, Kayanomori, Iizuka-shi, Fukuoka

Tel

0948225655

Email

ohnuki@fuk.kindai.ac.jp


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

2019 Year 12 Month 06 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

10

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

2018 Year 11 Month 01 Day

Date of IRB

2018 Year 03 Month 01 Day

Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2018 Year 12 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 06 Day

Last modified on

2019 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040069


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name