Irritable Bowel SyndromeNCT00829218
Clinical Trial Examining Effects of Monosodium Glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
A study testing Glutamate additive-free diet in people with Irritable Bowel Syndrome and Fibromyalgia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome, Fibromyalgia
- What is being tested?
- Glutamate additive-free diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75 who fulfill criteria for Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
- They must live in the greater Portland, OR, metro area, have transportation to/from study site, have access to email
- Willing to discontinue medications with bowel altering side effects
Who cannot join
- Asthma
- Inflammatory bowel disease
- Colon cancer or active endometriosis
- Any major abdominal surgery (excluding caesarean section, tubal ligation, hernia repair, gall bladder removal or appendectomy)
- Female and pregnant
- Currently taking pregabalin, gabapentin, or anti-psychotic medications and are unwilling/ unable to discontinue use
- Suffered from alcohol/substance abuse or psychosis in the last two years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97238
About this study
Official title: A Clinical Trial Examining the Effects of the Food Additive Glutamate on Irritable Bowel Syndrome and Fibromyalgia
Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.
Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify and recruit fibromyalgia patients who also have IBS to OHSU study centers.
Read more
Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a 1-month glutamate-free elimination diet. Those that respond positively to the diet (we are estimating 30-40 subjects), will then be randomized to receive either a citrus drink containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one week apart.
The investigators are hypothesizing that those who react positively to the elimination diet will have symptom occurrence statistically more frequently when given the glutamate challenge, than when given placebo.
- Conditions
- Irritable Bowel Syndrome, Fibromyalgia
- Being tested
- Glutamate additive-free diet, Placebo diet
- Keywords
- Irritable Bowel Syndrome, Fibromyalgia, Glutamate, Diet, Food additives
- Medical subject headings
- Irritable Bowel Syndrome, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamate additive-free dietOther
Also called Glutamate will be used as a challenge in the form of MSG.
All subjects will follow a diet for one month where all foods containing the additive glutamate have been removed. At the end of the one month diet, subjects who have responded positively to the diet will go onto the challenge arms of the study, where they will be randomized to receive placebo (mixed juice alone) for three days on one week, and 5 grams of glutamate in the mixed juice for three days on the other week.
Placebo dietOther
Juice with nothing added.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Glutamate challenge | Active comparator | Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 1 is the 5 grams of glutamate which will be given in a mixed juice. Receives: Other: Glutamate additive-free diet |
| 2- Placebo | Placebo comparator | Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 2 is the placebo arm, which will be juice with nothing added. Receives: Other: Glutamate additive-free diet; Other: Placebo diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the number of patients who have a positive response to a one month glutamate free diet, as measured by the Perception of Global Impression of Change (PGIC) scores
Measured: 4 weeks
To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores.
Measured: 6 weeks, 7 weeks
Secondary outcomes (3)
Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire
Measured: 4 weeks, 7 weeks
Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire
Measured: 4 weeks, 7 weeks
A reduction in pain based on two visual analog scales, one for gut pain, and another for musculo-skeletal pain
Measured: 4 weeks, 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Principal investigator, Kathleen F. Holton, Oregon Health and Science University
- Investigators
- Douglas Taren, PhD, Study chair, University of ArizonaKathleen F Holton, MPH, PhDc, Principal investigator, University of Arizona and Oregon Health & Science Univ.Kimberly D Jones, PhD, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829218
- Sponsor's protocol ID
- 4763
- Status last verified
- Dec 2013
- First submitted
- 23 Jan 2009
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holton KF, Taren DL, Thomson CA, Bennett RM, Jones KD. The effect of dietary glutamate on fibromyalgia and irritable bowel symptoms. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):10-7. Epub 2012 Dec 14.
PubMed 22766026
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Examining the Effects of the Food Additive Glutamate on Irritable Bowel Syndrome and Fibromyalgia
- ClinicalTrials.gov ID
- NCT00829218
- Acronym / sponsor ID
- 4763
- Conditions
- Irritable Bowel Syndrome, Fibromyalgia
- Keywords
- Irritable Bowel Syndrome, Fibromyalgia, Glutamate, Diet, Food additives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Jan 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.
Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.
Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify and recruit fibromyalgia patients who also have IBS to OHSU study centers.
Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a 1-month glutamate-free elimination diet. Those that respond positively to the diet (we are estimating 30-40 subjects), will then be randomized to receive either a citrus drink containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one week apart.
The investigators are hypothesizing that those who react positively to the elimination diet will have symptom occurrence statistically more frequently when given the glutamate challenge, than when given placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Glutamate challenge | Active comparator | Other: Glutamate additive-free dietGlutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 1 is the 5 grams of glutamate which will be given in a mixed juice. |
| 2- Placebo | Placebo comparator | Other: Glutamate additive-free diet, Other: Placebo dietGlutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 2 is the placebo arm, which will be juice with nothing added. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged 18-75 who fulfill criteria for Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
- They must live in the greater Portland, OR, metro area, have transportation to/from study site, have access to email
- Willing to discontinue medications with bowel altering side effects
Key exclusion criteria (7 listed)
- Asthma
- Inflammatory bowel disease
- Colon cancer or active endometriosis
- Any major abdominal surgery (excluding caesarean section, tubal ligation, hernia repair, gall bladder removal or appendectomy)
- Female and pregnant
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 |
|---|---|---|
| Glutamate additive-free dietAlso: Glutamate will be used as a challenge in the form of MSG.All subjects will follow a diet for one month where all foods containing the additive glutamate have been removed. At the end of the one month diet, subjects who have responded positively to the diet will go onto the challenge arms of the study, where they will be randomized to receive placebo (mixed juice alone) for three days on one week, and 5 grams of glutamate in the mixed juice for three days on the other week. | Other | 1 - Glutamate challenge, 2- Placebo |
| Placebo dietJuice with nothing added. | Other | 2- Placebo |
Primary outcome
To evaluate the number of patients who have a positive response to a one month glutamate free diet, as measured by the Perception of Global Impression of Change (PGIC) scores
Time frame: 4 weeks
To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores.
Time frame: 6 weeks, 7 weeks
3 secondary outcomes
Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire
Time frame: 4 weeks, 7 weeks
Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire
Time frame: 4 weeks, 7 weeks
A reduction in pain based on two visual analog scales, one for gut pain, and another for musculo-skeletal pain
Time frame: 4 weeks, 7 weeks
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 24 Dec 2013.
- Results publication: PubMed 22766026Holton KF, Taren DL, Thomson CA, Bennett RM, Jones KD. The effect of dietary glutamate on fibromyalgia and irritable bowel symptoms. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):10-7. Epub 2012 Dec 14.
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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.
Douglas Taren, PhD study chair
University of Arizona
Kathleen F Holton, MPH, PhDc principal investigator
University of Arizona and Oregon Health & Science Univ.
Kimberly D Jones, PhD study director
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamate additive-free diet in people with Irritable Bowel Syndrome and Fibromyalgia, run by Oregon Health and Science University at 1 site in United States.
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 7 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 24 Dec 2013. 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 United States. 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?
To evaluate the number of patients who have a positive response to a one month glutamate free diet, as measured by the Perception of Global Impression of Change (PGIC) scores (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829218, which also lists 1 linked publication.
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 24 Dec 2013.