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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039085
Receipt No. R000044574
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-
Date of disclosure of the study information 2020/01/09
Last modified on 2020/07/15

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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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