NCT01009658

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

5.2 years

First QC Date

November 6, 2009

Last Update Submit

March 25, 2015

Conditions

Gastroesophageal Reflux

Keywords

Gastrointestinal motilityGastroesophageal refluxGastric emptyingSodium glutamateLower esophageal sphincter

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying

    half emptying time

    0-5 hours

Study Arms (2)

MSG first

ACTIVE COMPARATOR
Dietary Supplement: Monosodium glutamate

NaCl first

PLACEBO COMPARATOR
Dietary Supplement: Sodium chloride

Interventions

Monosodium glutamateDIETARY_SUPPLEMENT

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.

MSG first
Sodium chlorideDIETARY_SUPPLEMENT

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.

NaCl first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gunma university hospital

Maebashi, Gunma, 3718511, Japan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Sodium GlutamateSodium Chloride

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Glutamic AcidGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

JP(1)