UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019943 |
|---|---|
| Receipt number | R000023028 |
| Scientific Title | The impact of chewing or dietary fiber intake on blood glucose |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2017/05/28 09:20:15 |
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Basic information
Public title
The impact of chewing or dietary fiber intake on blood glucose
Acronym
Chewing, dietary fiber and blood glucose
Scientific Title
The impact of chewing or dietary fiber intake on blood glucose
Scientific Title:Acronym
Chewing, dietary fiber and blood glucose
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether favorable effect of postprandial hyperglycemia is chewing or dietary fiber.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose of 30min, 60min and 120min and AUC of blood glucose
Key secondary outcomes
Insulin, GLP-1 and Serum lipids
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Chewing gum before a meal protocol is performed and then eating cabbage before a meal is performed after one week wash out period.
Interventions/Control_2
Eating cabbage before a meal is performed and then chewing gum before a meal is performed after one week wash out period.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatient in clinic at Kyoto Prefectural University of Medicine
1.No medication.
2.HbA1c is less than 7%.
Key exclusion criteria
The patient who judged that the chief physician was unsuitable for examination participation in planning. The patient who expressed non-consent of the participation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Fukui |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515505
sayarinapm@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Hashimoto |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515505
Homepage URL
y-hashi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Endocrinology and Metabolism
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
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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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
| 2016 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023028
