UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020667 |
|---|---|
| Receipt number | R000023850 |
| Scientific Title | The assessment of gastric emptying times of protein beverage in healthy volunteers: a randomized double-blind, crossover study |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2017/11/27 20:37:38 |
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Basic information
Public title
The assessment of gastric emptying times of protein beverage in healthy volunteers: a randomized double-blind, crossover study
Acronym
The assessment of gastric emptying times of protein beverage in healthy volunteers
Scientific Title
The assessment of gastric emptying times of protein beverage in healthy volunteers: a randomized double-blind, crossover study
Scientific Title:Acronym
The assessment of gastric emptying times of protein beverage in healthy volunteers
Region
| Japan |
Condition
Condition
preoperative patients
Classification by specialty
| Gastroenterology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will measure gastric emptying times by abdominal ultrasonography
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gastric emptying time of a protein beverage
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
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Each volunteer will ingest protein drink. After drinking,volunteer will undergo abdominal ultrasonography every 10 minutes until gastric emptying.
After 30-minute wash out period, volunteer will take protein-free drink containing similar calorie and undergo abdominal ultrasonography in the same way.
Interventions/Control_2
Each volunteer will ingest protein-free drink containing similar calorie . After drinking,volunteer will undergo abdominal ultrasonography every 10 minutes until gastric emptying.
After 30-minute wash out period, volunteer will take protein drink and undergo abdominal ultrasonography in the same way.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults categorized ASA physical status 1-2
Key exclusion criteria
1. Diabetes mellitus
2. Pregnancy
3. Body mass index > 35
4. Gastroesophageal reflux disease, gastric ulcer and duodenal ulcer
5. A history of epigastric surgery
6. Daily use of drug having effects on peristaltic movement
7. Allergies to milk, apple or grape
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ruri Ohba |
Organization
Tohoku Kosai Hospital
Division name
Department of anesthesiology
Zip code
Address
2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL
022-227-2245
ruri-ohba@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ruri Ohba |
Organization
Tohoku Kosai Hospital
Division name
Department of anesthesiology
Zip code
Address
2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL
022-227-2245
Homepage URL
ruri-ohba@gmail.com
Sponsor or person
Institute
Tohoku Kosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
東北公済病院（宮城県）
Tohoku Kosai Hospital(Miyagi)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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 | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023850
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
