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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025950
Receipt No. R000029247
Scientific Title A Study of the suppressive effect of glucomannan rice gruel on elevation of plasma glucose level in healthy adults.
Date of disclosure of the study information 2017/02/15
Last modified on 2019/08/05

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Basic information
Public title A Study of the suppressive effect of glucomannan rice gruel on elevation of plasma glucose level in healthy adults.
Acronym A Study of the suppressive effect of glucomannan rice gruel on elevation of plasma glucose level in healthy adults.
Scientific Title A Study of the suppressive effect of glucomannan rice gruel on elevation of plasma glucose level in healthy adults.
Scientific Title:Acronym A Study of the suppressive effect of glucomannan rice gruel on elevation of plasma glucose level in healthy adults.
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 depression effect of glycemic elevation of glycomannan gruel.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Plasma glucose elevation
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 rice gruel, once 250g
Interventions/Control_2 rice gruel with 0.4% glucomannan powder, once 250g
Interventions/Control_3 rice gruel with 0.8% glucomannan powder, once 250g
Interventions/Control_4 rice gruel with 1.2% glucomannan powder, once 250g
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 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 371-8511
Address 3-39-22, 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 371-8511
Address 3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan
TEL 027-220-8576
Homepage URL
Email ayossie10@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gunma University Hospital Clinical Research Review Board
Address 3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 15 Day

Related information
URL releasing protocol Nothing
Publication of results Unpublished

Result
URL related to results and publications Nothing
Number of participants that the trial has enrolled 26
Results Gruel containing glucomannan powder suppresses the increase of 30 minutes postprandial plasma glucose and insulin in a dose dependent manner.
Results date posted
2019 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics All males; ages ranged 37 to 60 years old. All subjects had no history of diabetes or gastrointestinal disease.
Participant flow fist visit : 75gOGTT
second, third, and fourth visit : glucomannan free rice gruel (0%G), rice gruel containing 0.4% glucomannan powder (0.4%G), and rice gruel containing 0.8% glucomannan powder (0.8%G) and blood sampling at preload and 30min, 60min, and 120min after taking gruel
Adverse events Adverse events did not occur.
Outcome measures suppression of elevation of plasma glucose and insulin after glucomannan containing gruel
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
2016 Year 12 Month 01 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2017 Year 07 Month 16 Day
Date of closure to data entry
2017 Year 07 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 01 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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