UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The assessment of gastric emptying times of protein beverage in healthy volunteers: a randomized double-blind, crossover study
Title of the study (Brief title)	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	Ruri Ohba
Organization	Tohoku Kosai Hospital
Division name	Department of anesthesiology
Address	2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL	022-227-2245
Email	ruri-ohba@gmail.com

Public contact
Name of contact person	Ruri Ohba
Organization	Tohoku Kosai Hospital
Division name	Department of anesthesiology
Address	2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL	022-227-2245
Homepage URL
Email	ruri-ohba@gmail.com

Sponsor
Institute	Tohoku Kosai 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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023850