UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020712 |
|---|---|
| Receipt number | R000023898 |
| Scientific Title | Does canned coffee delay gastric emptying? (gastric ultrasound measurement ) |
| Date of disclosure of the study information | 2016/01/23 |
| Last modified on | 2016/02/29 22:28:55 |
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Basic information
Public title
Does canned coffee delay gastric emptying? (gastric ultrasound measurement )
Acronym
Does canned coffee delay gastric emptying? (gastric ultrasound measurement )
Scientific Title
Does canned coffee delay gastric emptying? (gastric ultrasound measurement )
Scientific Title:Acronym
Does canned coffee delay gastric emptying? (gastric ultrasound measurement )
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to measure the effect of the rate of gastric emptying of canned coffee with milk and sugar.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cross-sectional area of gastric antrum at each time were compared to each soft drink fasting value.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The change of the cross-sectional
area of the gastric antrum
over time after fasting.
Interventions/Control_2
The change of the cross-sectional
area of the gastric antrum
over time after drinking water.
Interventions/Control_3
The change of the cross-sectional
area of the gastric antrum
over time after drinking black coffee.
Interventions/Control_4
The change of the cross-sectional
area of the gastric antrum
over time after drinking canned coffee.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers who agreed to be included in the study.
Key exclusion criteria
Subjects were excluded if they had known taking any medication known to alter gastric emptying or motor function.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misako Higuchi |
Organization
Wakayama Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera Wakayamashi
TEL
073-447-2300
higuchim@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misako Higuchi |
Organization
Wakayama Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera Wakayamashi
TEL
073-447-2300
Homepage URL
higuchim@wakayama-med.ac.jp
Sponsor or person
Institute
Tomakomai City 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 23 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The ultrasound measurement of the cross-sectional area of the gastric antrum were used to assess gastric emptying after prolonged fasting or ingestion of 300ml of water or black coffee or canned coffee with milk and sugar.
Management information
Registered date
| 2016 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023898
