UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038067 |
|---|---|
| Receipt number | R000043384 |
| Scientific Title | A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect Rondomised,double blind, placebo controlled crossover study |
| Date of disclosure of the study information | 2019/09/20 |
| Last modified on | 2019/09/20 17:08:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect
Rondomised,double blind, placebo controlled crossover study
Acronym
A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect
Scientific Title
A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect
Rondomised,double blind, placebo controlled crossover study
Scientific Title:Acronym
A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect
Rondomised,double blind, placebo controlled crossover study
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the blood glucose elevation inhibitory effect of a single intake of test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose
Insulin
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of study food
Interventions/Control_2
Single ingestion of control food
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 64
(2)Subjects who received a sufficient explanation of the purpose and contents of the study, an ability to consent, a volunteer who volunteered to participate with a good understanding and who agreed to participate in the study
Key exclusion criteria
(1) Subjects with a history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disorder, and other serious diseases
(2) Subjects who may have allergic symptoms due to ingredients in the test food
(3) Subjects with impaired cardiopulmonary function
(4) Subjects with abnormal liver and kidney function test values
(5) Subjects who have undergone gastrointestinal surgery
(6) Subjects with a disease currently being treated
(7) Subjects with food and drug allergies
(8) Subjects who have a habit of smoking
(9) Subjects who play intense sports and are on a diet
(10) Subjects taking food, health foods, quasi-drugs, and pharmaceuticals (including OTC and prescription drugs) that may affect the endpoints of the study
(11) Subjects who are excessively consuming alcohol or subjects who cannot ban alcohol from 2 days before the test date
(12) Subjects who are pregnant or who are scheduled to become pregnant or breastfeeding during the study period
(13) Subjects who are or will be participating in other clinical studies at the start of this study
(14) Other subjects deemed inappropriate by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0661355200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
frat field operations Co.,Ltd.
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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
0661355200
mterashima@miura-cl.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
| 2019 | Year | 09 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2019 | Year | 09 | Month | 20 | Day |
Last modified on
| 2019 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043384
