Gastroesophageal RefluxNCT01009658
MSG and Gastrointestinal Motility
A study testing Monosodium glutamate and Sodium chloride in people with Gastroesophageal Reflux, run by Gunma University at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Monosodium glutamate and Sodium chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2009to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Must not have digestive symptoms
- Must not eat within six hours of study participation
Who cannot join
- Regular medications for the gastrointestinal tract
- Previous Helicobacter pylori infection
- Previous abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Monosodium Glutamate on Upper Gastrointestinal Tract Motility
The purpose of this study is to clarify the physiological function of sodium glutamate by measuring its effect on upper GI motility ( gastric emptying).
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Monosodium glutamate, Sodium chloride
- Keywords
- Gastrointestinal motility, Gastroesophageal reflux, Gastric emptying, Sodium glutamate, Lower esophageal sphincter
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| MSG first | Active comparator | Not described Receives: Dietary Supplement: Monosodium glutamate |
| NaCl first | Placebo comparator | Not described Receives: Dietary Supplement: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
half emptying time
Measured: 0-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gunma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroko Hosaka, Gunma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009658
- Sponsor's protocol ID
- GU-696
- Other IDs
- GU-CT 696
- Status last verified
- Mar 2015
- First submitted
- 6 Nov 2009
- Last updated
- 26 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monosodium Glutamate on Upper Gastrointestinal Tract Motility
- ClinicalTrials.gov ID
- NCT01009658
- Acronym / sponsor ID
- GU-696
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastrointestinal motility, Gastroesophageal reflux, Gastric emptying, Sodium glutamate, Lower esophageal sphincter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gunma UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2015 (actual)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSG first | Active comparator | Dietary Supplement: Monosodium glutamate |
| NaCl first | Placebo comparator | Dietary Supplement: Sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Must not have digestive symptoms
- Must not eat within six hours of study participation
Key exclusion criteria (3 listed)
- Regular medications for the gastrointestinal tract
- Previous Helicobacter pylori infection
- Previous abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monosodium glutamateOral intake of 2.0 g of monosodium glutamate on the examination day and 0.6 g of sodium chloride on the other examination day. | Dietary supplement | MSG first |
| Sodium chlorideOral intake of 0.6 g of sodium chloride on the examination day and 2.0 g of monosodium glutamate on the other examination day. | Dietary supplement | NaCl first |
Primary outcome
Gastric emptying
Time frame: 0-5 hours
half emptying time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monosodium glutamate and Sodium chloride in people with Gastroesophageal Reflux, run by Gunma University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying (time frame: 0-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.