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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | |||||
Condition | Healthy adults | ||||
Classification by specialty |
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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 |
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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). |
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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. |
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kumamoto Kinoh Hospital
Division of Anesthesia |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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Last modified on |
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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 |