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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020712
Receipt No. 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

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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
Email 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
Email higuchim@wakayama-med.ac.jp

Sponsor
Institute Tomakomai City Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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