UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035167 |
|---|---|
| Receipt number | R000040080 |
| Scientific Title | Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study |
| Date of disclosure of the study information | 2018/12/07 |
| Last modified on | 2019/05/09 11:42:19 |
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Basic information
Public title
Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Acronym
Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Scientific Title
Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Scientific Title:Acronym
Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of single intake of 3 dose(200mg,500mg,1000mg) 1,5-anhydro-D-fructose on postprandial blood glucose level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose level (AUC)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1. 1st visit: Screening (Observation of blood sugar level after a meal)
2. 2nd visit: Single intake of a study food
(Observation of blood glucose levels on before food, after 30 minutes, 60 minutes, 90 minutes, and 120 minutes)
Interventions/Control_2
1. 1st visit: Screening (Observation of blood sugar level after a meal)
2. 2nd visit: Single intake of a study food
(Observation of blood glucose levels on before food, after 30 minutes, 60 minutes, 90 minutes, and 120 minutes)
Interventions/Control_3
1. 1st visit: Screening (Observation of blood sugar level after a meal)
2. 2nd visit: Single intake of a study food
(Observation of blood glucose levels on before food, after 30 minutes, 60 minutes, 90 minutes, and 120 minutes)
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
| 61 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The person who does not treat the disease
2. Adult aged from 20y to 60y,both sexes, the person who participates voluntarily
3. Subjects with fasting blood glucose level under 125mg/dl
4. The person who is relatively high in blood sugar level after a meal at the time of the prior screening examination
5. Serious disease (mental diseases such as diabetes, a heart trouble, a liver disease, renal disease, a malignant tumor and the depression) without the anamnesis
6. The person who can maintain an everyday lifestyle during testing period constantly
Key exclusion criteria
1. Person with a history of the past who treat a serious disease (mental diseases such as diabetes, a heart trouble, a liver disease, renal disease, a malignant tumor and the depression)
2. More than 6.5% of hemoglobin A1c (NGSP)
3. After a meal the blood sugar level of 120 minutes more than 200 mg/dL
4. The person whom alimentary system such as gastric resection has in an operation career
5. The person who cannot maintain an everyday lifestyle constantly
6. Person with the shift work, person with the graveyard shift
7. Food allergy for the test food, the drug allergy which are thought about
8. A pregnant woman, nursing girl and the person who hope for the pregnancy all over the study time
9. Participants in other clinical trial
10. Other persons who were judged inappropriate by principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Furihata |
Organization
P-One Clinic, Keikokai Medical Corporation.
Division name
Clinic Director
Zip code
Address
View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
TEL
042-625-5216
furihata@p1-clinic.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Uetake |
Organization
CXwellness, Inc.
Division name
CEO
Zip code
Address
516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo,Japan.
TEL
03-6225-5601
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
P-One Clinic, Keikokai Medical Corporation.
Institute
Department
Personal name
Funding Source
Organization
Dr's choice 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
Address
Tel
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 | 12 | Month | 07 | 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
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 25 | 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 | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040080
