UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023986 |
|---|---|
| Receipt number | R000027586 |
| Scientific Title | A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles. |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2018/08/15 13:54:20 |
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Basic information
Public title
A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles.
Acronym
A study of healthy adult males in a crossover comparison trial of noodles containing 0 grams of sugar vs commercially available noodles
Scientific Title
A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles.
Scientific Title:Acronym
A study of healthy adult males in a crossover comparison trial of noodles containing 0 grams of sugar vs commercially available noodles
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regarding postprandial blood glucose levels of humans for noodles containing 0 grams of sugar, it was found that postprandial blood glucose levels do not rise easily when compared with commercially available noodles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Insulin
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
noodles containing 0 grams of sugar
Interventions/Control_2
commercially available noodles
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Healthy adult males
Age:20 years old -35 years old
2)Blood glucose level:60-110mg/dL
3)Syphilis(-),HIV(-),HBsAg(-),HCV(-)
4)Written informed consent
Key exclusion criteria
1)People with an allergy towards wheat, soybean and ingredients from other experimental diets
2)People who regularly take supplements, health products and specified health foods that have an effect on blood sugar levels
3)People with Serious complications
4)People with Psychiatric disorder
5)People who participated in other trial within 4 months
6)People who judged inappropriate for this study by the treating physician
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tsunematsu |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Department of Research
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6350
tunematu@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Takenaga |
Organization
Kitasato Academic Research Organization, Kitasato University
Division name
Clinical Trial Coordinating Center
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6400
Homepage URL
takena-t@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
KIBUN FOODS INC
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
北里大学北里研究所病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027586
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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