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Monosodium Glutamate on Gastric Emptying

Primary Purpose

Delayed Gastric Emptying

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monosodium glutamate
Sponsored by
Veronica Beatriz Busoni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Gastric Emptying focused on measuring delayed gastric emptying, children, monosodium glutamate

Eligibility Criteria

12 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 7, 2016
    Last Updated
    February 28, 2023
    Sponsor
    Veronica Beatriz Busoni
    Collaborators
    International Glutamate Technical Committee
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    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    Withdrawn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
    Questions and Answers on Monosodium glutamate

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