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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02745028
Other study ID # 2404
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date October 2017

Study information

Verified date February 2023
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 12 Months to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Monosodium glutamate
A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Veronica Beatriz Busoni International Glutamate Technical Committee

References & Publications (4)

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/ — View 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 — View 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. eColle — View 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 200 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduced gastric emptying time Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline During the test (4 hours from intake)
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