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MSG and Gastrointestinal Motility

Primary Purpose

Gastroesophageal Reflux

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Monosodium glutamate

Sodium chloride

About this trial

This is an interventional basic science trial for Gastroesophageal Reflux focused on measuring Gastrointestinal motility, Gastroesophageal reflux, Gastric emptying, Sodium glutamate, Lower esophageal sphincter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects
Must not have digestive symptoms
Must not eat within six hours of study participation

Exclusion Criteria:

Regular medications for the gastrointestinal tract
Previous Helicobacter pylori infection
Previous abdominal surgery

Sites / Locations

Gunma university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MSG first

NaCl first

Arm Description

Outcomes

Primary Outcome Measures

Gastric emptying

half emptying time

Secondary Outcome Measures

Full Information

NCT ID

NCT01009658

First Posted

November 6, 2009

Last Updated

March 25, 2015

Sponsor

Gunma University

1. Study Identification

Unique Protocol Identification Number

NCT01009658

Brief Title

MSG and Gastrointestinal Motility

Official Title

Effect of Monosodium Glutamate on Upper Gastrointestinal Tract Motility

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gunma University

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to clarify the physiological function of sodium glutamate by measuring its effect on upper GI motility ( gastric emptying).

Detailed Description

Amino acids such as monosodium glutamate are known to stimulate both endocrine and exocrine secretion. In addition, there is a report that oral intake of glutamate evokes the activation of vagal afferent nerves in the rat. Thus, such amino acids are thought to be influential in the process of digestion and absorption. . To investigate the effect of monosodium glutamate on gastrointestinal motility, we planned a single-blind randomized study. The participants will take either monosodium glutamate or sodium chloride before the first examination of upper GI motility and the other agent before the second examination. The order of intake will be randomized by the envelope method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

Keywords

Gastrointestinal motility, Gastroesophageal reflux, Gastric emptying, Sodium glutamate, Lower esophageal sphincter

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSG first

Arm Type

Active Comparator

Arm Title

NaCl first

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Monosodium glutamate

Intervention Description

Oral intake of 2.0 g of monosodium glutamate on the examination day and 0.6 g of sodium chloride on the other examination day.

Intervention Type

Dietary Supplement

Intervention Name(s)

Sodium chloride

Intervention Description

Oral intake of 0.6 g of sodium chloride on the examination day and 2.0 g of monosodium glutamate on the other examination day.

Primary Outcome Measure Information:

Title

Gastric emptying

Description

half emptying time

Time Frame

0-5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects Must not have digestive symptoms Must not eat within six hours of study participation Exclusion Criteria: Regular medications for the gastrointestinal tract Previous Helicobacter pylori infection Previous abdominal surgery

Facility Information:

Facility Name

Gunma university hospital

City

Maebashi

State/Province

Gunma

ZIP/Postal Code

3718511

Country

Japan

12. IPD Sharing Statement

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MSG and Gastrointestinal Motility

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