Monosodium Glutamate on Gastric Emptying
Primary Purpose
Delayed Gastric Emptying
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monosodium glutamate
Sponsored by
About this trial
This is an interventional treatment trial for Delayed Gastric Emptying focused on measuring delayed gastric emptying, children, monosodium glutamate
Eligibility Criteria
Inclusion Criteria:
- children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours
Exclusion Criteria:
- Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
With monosodium glutamate
Arm Description
Results of one time gastric emptying study with a single dose of monosodium glutamate; 1 g for weight greater than 45 kg, 700mg between 35 and 44,900 kg, 600mg between 25 and 34,900, 500mg between 15 and 25 kg and 250mg in less than 15 kg
Outcomes
Primary Outcome Measures
Reduced gastric emptying time
Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT02745028
First Posted
April 7, 2016
Last Updated
February 28, 2023
Sponsor
Veronica Beatriz Busoni
Collaborators
International Glutamate Technical Committee
1. Study Identification
Unique Protocol Identification Number
NCT02745028
Brief Title
Monosodium Glutamate on Gastric Emptying
Official Title
Effect of a Single Dose of Monosodium Glutamate on Delayed Gastric Emptying in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The protocol was cancelled becouse lack of funding
Study Start Date
April 2016 (Anticipated)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Veronica Beatriz Busoni
Collaborators
International Glutamate Technical Committee
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.
Detailed Description
There is evidence that monosodium glutamate has effects on synapsis at the gastric and duodenum level that results in stimulation of contractility resulting on increase rate of gastric emptying. The purpose of the study is to demonstrate that the administration of a single dose of monosodium glutamate can shorten the gastric emptying time.
Patients with a prior study indicating a delay of gastric empting time, will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. Each patient will serve as her/his own control. Results will be analysed by pair-T test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Gastric Emptying
Keywords
delayed gastric emptying, children, monosodium glutamate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With monosodium glutamate
Arm Type
Other
Arm Description
Results of one time gastric emptying study with a single dose of monosodium glutamate; 1 g for weight greater than 45 kg, 700mg between 35 and 44,900 kg, 600mg between 25 and 34,900, 500mg between 15 and 25 kg and 250mg in less than 15 kg
Intervention Type
Dietary Supplement
Intervention Name(s)
Monosodium glutamate
Intervention Description
A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study
Primary Outcome Measure Information:
Title
Reduced gastric emptying time
Description
Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline
Time Frame
During the test (4 hours from intake)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours
Exclusion Criteria:
Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica B Busoni, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24744869
Citation
Teramoto H, Shimizu T, Yogo H, Nishimiya Y, Hori S, Kosugi T, Nakayama S. Gastric emptying and duodenal motility upon intake of a liquid meal with monosodium glutamate in healthy subjects. Physiol Rep. 2014 Jan 6;2(1):e00187. doi: 10.1002/phy2.187. eCollection 2014 Jan 1.
Results Reference
result
PubMed Identifier
19056566
Citation
Zai H, Kusano M, Hosaka H, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium L-glutamate added to a high-energy, high-protein liquid diet promotes gastric emptying. Am J Clin Nutr. 2009 Jan;89(1):431-5. doi: 10.3945/ajcn.2008.26180. Epub 2008 Dec 3.
Results Reference
result
PubMed Identifier
21030612
Citation
Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tome D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.
Results Reference
result
PubMed Identifier
22978669
Citation
Hosaka H, Kusano M, Zai H, Kawada A, Kuribayashi S, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium glutamate stimulates secretion of glucagon-like peptide-1 and reduces postprandial glucose after a lipid-containing meal. Aliment Pharmacol Ther. 2012 Nov;36(9):895-903. doi: 10.1111/apt.12050.
Results Reference
result
Links:
URL
http://www.fda.gov/food/ingredientspackaginglabeling/foodadditivesingredients/ucm328728.htm
Description
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