UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026035
Receipt No. R000029925
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.
Date of disclosure of the study information 2017/02/07
Last modified on 2018/06/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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)
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 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


Contact us.