UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039601 |
|---|---|
| Receipt number | R000045109 |
| Scientific Title | Evaluation of the efficacy of dietary fiber-containing beverage on postprandial blood glucose elevation |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2020/04/28 10:26:08 |
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Basic information
Public title
Evaluation of the efficacy of dietary fiber-containing beverage on postprandial blood glucose elevation
Acronym
The effect of dietary fiber-containing beverage on postprandial blood glucose
Scientific Title
Evaluation of the efficacy of dietary fiber-containing beverage on postprandial blood glucose elevation
Scientific Title:Acronym
The effect of dietary fiber-containing beverage 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 of dietary fiber-containing beverage 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, the peak value of blood glucose levels, delta blood glucose levels, delta Cmax (the peak value of 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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drinking placebo beverage with eating 150 g of cooked rice
Interventions/Control_2
Drinking dietary fiber-containing beverage with eating 150 g of cooked rice
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy adults (20 years or older) who do not get treatment or medication
2) Subjects who are normoglycemia or borderline diabetes in previous medical check-ups
3) Subjects whose fasting blood glucose levels are less than 126 mg/dL or blood glucose levels after oral glucose tolerance test (OGTT) are less than 200 mg/dL in the screening test
4) Subjects who do not fit the key exclusion criteria
5) Subjects who are judged healthy by investigators
Key exclusion criteria
1) Subjects who have food allergy to the test meals
2) Subjects who have remarkable hypersensitivity to alcohol
3) Subjects who will get pregnant or breast-feed during the study period
4) Subjects who join other human studies
5) Subjects who are judged unsuitable for this study by investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Inoue |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Takuro_Inoue@kagome.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F, 5-31-19, Shiba, Minato-ku, Tokyo
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.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
HUMA R&D CORP
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-1-3 Yaesu, Chuo-ku, Tokyo
Tel
03-5204-0311
jim@medipharma.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
医療法人社団桜緑会 日本橋さくらクリニック(東京都)（Nihonbashi Sakura Clinic）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 25 | 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
50
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
| 2020 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045109
