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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | Period I:Placebo beverage
Wash out Period II:Beverage containing low molecular weight glucomannan Carbohydrate load:retort cooked rice(260g) |
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Interventions/Control_2 | Period I:Beverage containing low molecular weight glucomannan
Wash out Period II:Placebo beverage Carbohydrate load:retort cooked rice(260g) |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |