Clinical Trial Examining Effects of Monosodium Glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)

December 21, 2013 updated by: Kathleen F. Holton, Oregon Health and Science University

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.

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 Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97238
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 - Glutamate challenge
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.
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 Names:
  • Glutamate will be used as a challenge in the form of MSG.
Placebo Comparator: 2- Placebo
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.
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 Names:
  • Glutamate will be used as a challenge in the form of MSG.
Juice with nothing added.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
6 weeks, 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire
Time Frame: 4 weeks, 7 weeks
4 weeks, 7 weeks
Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire
Time Frame: 4 weeks, 7 weeks
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
4 weeks, 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Douglas Taren, PhD, University of Arizona
  • Principal Investigator: Kathleen F Holton, MPH, PhDc, University of Arizona and Oregon Health & Science Univ.
  • Study Director: Kimberly D Jones, PhD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 21, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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