UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039085 |
|---|---|
| Receipt number | 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 11:33:41 |
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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
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
moto@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044574
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
