UMIN-CTR Clinical Trial

Basic information
Public title	Comparative evaluation of gastric emptying in healthy adults after ingestion of carbohydrate-enriched beverages with and without a thickener using real-time ultrasonography: a randomized, crossover clinical trial.
Acronym	Gastric emptying of a carbohydrate-enriched beverage with a thickener in healthy adults
Scientific Title	Comparative evaluation of gastric emptying in healthy adults after ingestion of carbohydrate-enriched beverages with and without a thickener using real-time ultrasonography: a randomized, crossover clinical trial.
Scientific Title:Acronym	Gastric emptying of a carbohydrate-enriched beverage with a thickener in healthy adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Neurology Geriatrics Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The determine the benchmark for gastric emptying time of carbohydrate enriched beverages with and without a xanthan gum thickener in normal healthy adults in order to determine safe preoperation fasting times in dysphagia adult patients being fed with the thickener in the future.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The gastric emptying time, the duration between ingestion of the tested solution and the time point at which the ultrasonographic cross-sectional area of the gastric antrum returns to less than +15% of the baseline value at fasting or 4 cm2.
Key secondary outcomes	Subjective impression about tested solution, the incidence of discomforts or symptom after ingestion of test solution.

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	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The participant drinks 250 ml of a carbohydrate-enriched beverage (Arginaid water, Nestle Health Science, Tokyo, Japan). Leaving at least 5-day washout interval after the first trial, the participant drinks 250 ml of the beverage mixed a xanthan gum thickener (Toromi-clear, Healthy Food, Tokyo, Japan).
Interventions/Control_2	The participant drinks 250 mL of a carbohydrate-enriched beverage (Arginaid water, Nestle Health Science, Tokyo, Japan e) mixed with a xanthan gum thickener (Toromi-clear, Healthy Food, Tokyo, Japan). Leaving at least 5-day washout interval after the first trial, the participant drinks the beverage alone.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy volunteers who give written informed consent.
Key exclusion criteria	Past gastrointestinal disorders that required in-hospital treatment Diabetes mellitus Morbid obesity (BMI>35) Pregnant woman / Breast feeding mother Orally medicated Dysphagia Diarrhea
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Chiho Uneda
Organization	Kumamoto Kinoh Hospital
Division name	Division of Anesthesia
Zip code
Address	6-8-1 Yamamuro Kita-ku Kumamoto-shi, 860-8516, Japan
TEL	096-345-8111
Email	chihoanego@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Chiho Uneda
Organization	Kumamoto Kinoh Hospital
Division name	Division of Anesthesia
Zip code
Address	6-8-1 Yamamuro Kita-ku Kumamoto-shi, 860-8516, Japan
TEL	096-345-8111
Homepage URL
Email	chihoanego@yahoo.co.jp

Sponsor
Institute	Kumamoto Kinoh Hospital Division of Anesthesia
Institute
Department

Funding Source
Organization	Self funding
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)
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Address
Tel
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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	熊本機能病院（熊本県）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 07 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 06 Month 21 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 28 Day
Last follow-up date	2017 Year 12 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	2017 Year 02 Month 07 Day
Last modified on	2018 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029925

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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