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

NCT ID: NCT00829218

Last Updated: 2013-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-05-31

Brief 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.

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.

Conditions

Irritable Bowel Syndrome; Fibromyalgia

Keywords

Irritable Bowel Syndrome; Fibromyalgia; Glutamate; Diet; Food additives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Glutamate additive-free diet

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Glutamate additive-free diet

Intervention Type: OTHER

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 diet

Intervention Type: OTHER

Juice with nothing added.

Interventions

Glutamate additive-free diet

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.

Intervention Type: OTHER

Placebo diet

Juice with nothing added.

Intervention Type: OTHER

Other Intervention Names

Glutamate will be used as a challenge in the form of MSG.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Kathleen F. Holton

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Taren, PhD

Role: STUDY_CHAIR

University of Arizona

Kathleen F Holton, MPH, PhDc

Role: PRINCIPAL_INVESTIGATOR

University of Arizona and Oregon Health & Science Univ.

Kimberly D Jones, PhD

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22766026 (View on PubMed)

Other Identifiers

4763

Identifier Type: -

Identifier Source: org_study_id