UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026035 |
|---|---|
| Receipt number | 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 16:07:18 |
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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
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
chihoanego@yahoo.co.jp
Sponsor or person
Institute
Kumamoto Kinoh Hospital
Division of Anesthesia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029925
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