UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034771 |
|---|---|
| Receipt number | R000039616 |
| Scientific Title | Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation |
| Date of disclosure of the study information | 2018/11/15 |
| Last modified on | 2019/11/25 11:59:13 |
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Basic information
Public title
Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Acronym
The effect of dietary fibers on postprandial blood glucose
Scientific Title
Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Scientific Title:Acronym
The effect of dietary fibers on postprandial blood glucose
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose levels, delta blood glucose levels, delta Cmax (The peak value of the delta blood glucose levels), IAUC (Areas calculated based on the change of delta blood glucose levels)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drinking 200 mL of water with eating 150 g of cooked rice
Interventions/Control_2
Drinking 200 mL of test beverage A (low dietary fiber)with eating 150 g of cooked rice
Interventions/Control_3
Drinking 200 mL of test beverage B(high dietary fiber X) with eating 150 g of cooked rice
Interventions/Control_4
Drinking 200 mL of test beverage C(high dietary fiber Y) with eating 150 g of cooked rice
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who satisfy the following conditions
1) Who do not fit key exclusion criteria
2) Who provide written informed consents
Key exclusion criteria
1) Who has abnormal glucose tolerance in medical check-ups for the prior year
2) Who has food allergy to the test meals
3) Who has remarkable hypersensitivity to alcohol
4) Who will get pregnant or breast-feed during the study period
5) Who join other human studies
6) Who are judged unsuitable for this study by principal investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Aizawa |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL
+81-287-36-2935
Koichi_Aizawa@kagome.co.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Yoshida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL
+81-287-36-2935
Homepage URL
Kazutaka_Yoshida@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
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
KAGOME CO., LTD.
Address
3-21-1 Nihonbashihamacho, Chuoku, Tokyo, Japan
Tel
+81-3-5623-8501
Takuji_Hayakawa@kagome.co.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
| 2018 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039616
| 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 |
