UMIN-CTR Clinical Trial

Basic information
Public title	A study for the suppressive effect of the beverage containing low molecular weight glucomannan on the elevation of postprandial blood glucose
Acronym	A study for the suppressive effect of the beverage containing low molecular weight glucomannan on the elevation of postprandial blood glucose
Scientific Title	A study for the suppressive effect of the beverage containing low molecular weight glucomannan on the elevation of postprandial blood glucose in healthy subjects -A randomized, placebo-controlled, double-blind, crossover trial-
Scientific Title:Acronym	A study for the suppressive effect of the beverage containing low molecular weight glucomannan on the elevation of postprandial blood glucose in healthy subjects
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the suppressive effect of the beverage containing low molecular weight glucomannan on the elevation of postprandial blood glucose
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose levels at each measurement point
Key secondary outcomes	1.Blood glucose elevation levels at each measurement point 2.The incremental area under the curve of the blood glucose levels 3.The area under the curve of the blood glucose levels

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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Period I:Placebo beverage Wash out Period II:Beverage containing low molecular weight glucomannan Carbohydrate load:retort cooked rice(260g)
Interventions/Control_2	Period I:Beverage containing low molecular weight glucomannan Wash out Period II:Placebo beverage Carbohydrate load:retort cooked rice(260g)
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 and Female
Key inclusion criteria	1. Subjects 20 to 59 years of age 2. Healthy subjects 3. Subjects who have no allergy to the test food containing erythritol 4. Subjects who consent to participate in the study, and can sign the consent form
Key exclusion criteria	1. Subjects who have a medical history of diabetes. 2. Subjects whose fasting blood glucose levels are more than 126 mg/dL 3.Subjects who are under medication or having a history of serious diseases for which medication was required. 4. Subjects who have allergy to food 5. Subjects who have extreme diarrhea 6. Subjects who routinely use medicine, supplements, and/or health food which affect to result of the study 7. Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating 8. Subjects who is considered to be inappropriate to attend the present study by the research contact person
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kaname Middle name Last name Katsuraya
Organization	Wayo Women's University Graduate School
Division name	Faculty of Human Ecology
Zip code	272-8533
Address	2-3-1 konodai, Ichikawa, Chiba, Japan
TEL	047-371-2482
Email	katsuraya@wayo.ac.jp

Public contact
Name of contact person	1st name Mihoko Middle name Last name Moto
Organization	Wayo Women's University
Division name	Department of Health and Nutrition
Zip code	272-8533
Address	2-3-1 konodai, Ichikawa, Chiba, Japan
TEL	047-371-2393
Homepage URL
Email	moto@wayo.ac.jp

Sponsor
Institute	Wayo Women's University
Institute
Department

Funding Source
Organization	Shimonita - Bussan
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	Wayo Women's University Research Support Division
Address	2-3-1 konodai, Ichikawa, Chiba, Japan
Tel	047-371-1184
Email	k-shien@wayo.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	和洋女子大学（千葉県）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 09 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
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	2020 Year 01 Month 07 Day
Date of IRB	2019 Year 12 Month 12 Day
Anticipated trial start date	2020 Year 01 Month 27 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 08 Day
Last modified on	2020 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044574

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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