UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030935
Receipt number R000034973
Scientific Title Evaluation of the effect of preprandial ingestion of novel glucomannan containing food on human health.
Date of disclosure of the study information 2018/01/31
Last modified on 2023/02/09 10:39:35

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Basic information

Public title

Evaluation of the effect of preprandial ingestion of novel glucomannan containing food on human health.

Acronym

Evaluation of the effect of preprandial ingestion of novel glucomannan containing food on human health.

Scientific Title

Evaluation of the effect of preprandial ingestion of novel glucomannan containing food on human health.

Scientific Title:Acronym

Evaluation of the effect of preprandial ingestion of novel glucomannan containing food on human health.

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyse the inhibitory effect of the glucomannan capsule on plasma glucose elevation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Suppression of the elevation of plasma glucose

Key secondary outcomes

Elevation of incretin


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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

capsules contains 2g glucomannan powder and TRELAN-G75 at once

Interventions/Control_2

empty capsules and TRELAN-G75 at once

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

60 years-old >=

Gender

Male

Key inclusion criteria

healthy subjects or diabetes patients with HbA1c <8%

Key exclusion criteria

diabetes patients with HbA1c >= 8%
diabetes patients under treatment
patients with severe constipation

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Yoshida

Organization

Gunma University Hospital

Division name

Department of Clinical Laboratory Medicine

Zip code

371-0033

Address

3-39-15, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan

TEL

027-220-8576

Email

ayossie10@gunma-u.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Yoshida

Organization

Gunma University Hospital

Division name

Department of Clinical Laboratory Medicine

Zip code

371-0033

Address

3-39-15, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan

TEL

027-220-8576

Homepage URL


Email

ayossie10@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

ORIHIRO Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

ethical view board

Address

3-39-15 Showa-town Maebashi-city

Tel

027-220-8740

Email

gunmaciru-office@umin.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

群馬大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 31 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

20

Results

Diarrhea and constipation were not observed by ingestion of glucomannan capsules before 75gOGTT, but the suppression effect on blood glucose increase was not observed.

Results date posted

2023 Year 02 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

20 men without diagnosis of diabetes

Participant flow

After receiving 75g OGTT, they took capsules containing glucomannan and not containing konjac powder, performed 75g OGTT, and measured blood glucose over time.

Adverse events

None

Outcome measures

postload glucose and insulin

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 28 Day

Date of IRB

2017 Year 12 Month 28 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2018 Year 12 Month 28 Day

Date of closure to data entry

2018 Year 12 Month 28 Day

Date trial data considered complete

2018 Year 12 Month 28 Day

Date analysis concluded

2019 Year 12 Month 28 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 22 Day

Last modified on

2023 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034973


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name