UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035110 |
|---|---|
| Receipt number | R000040017 |
| Scientific Title | An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2019/06/04 09:24:34 |
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Basic information
Public title
An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Acronym
The effect of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Scientific Title
An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Scientific Title:Acronym
The effect of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism | Gastrointestinal surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Physical properties in stomach
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Novel enteral nutrition using thickening agents VVT-01
Interventions/Control_2
Liquid enteral nutrition
Interventions/Control_3
Commercially available enteral nutrition using thickening agents
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
aged 20-64 years
Key exclusion criteria
1.Subject who are pregnant or under lactation, or expected to be pregnant during the study
2.Subjects who have serious history or receiving treatment of liver, kidney, heart, lung, digestive, hematological and metabolic disease
3.Subjects who are chronic disease
4.Subjects who have history of serious food or drug allergy
5.Subjects who have fasting blood glucose 69>= or 100<=
6.Subjects who have HbA1c 4.5>= or 5.6<=
7.Subjects who are planning to participate in the other study during the study period
8.Subjects judged inappropriate for the study by the principal investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Mizuno |
Organization
Mejiro Second General Hospital
Division name
Department of Surgery
Zip code
Address
1980, Hussa, Hussa, Tokyo, 197-0011, Japan
TEL
042-553-3511
zbm05143@sky.zero.ad.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Mizuno |
Organization
Mejiro Second General Hospital
Division name
Department of Surgery
Zip code
Address
1980, Hussa, Hussa, Tokyo, 197-0011, Japan
TEL
042-553-3511
Homepage URL
zbm05143@sky.zero.ad.jp
Sponsor or person
Institute
Mejiro Second General Hospital
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO.
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 | 03 | 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 | 22 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
