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Effect of Revival Soy on Fibromyalgia Pain

This study has been completed.
Sponsor:
Collaborator:
Physicians Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279942
First received: January 18, 2006
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

Fibromyalgia is characterized by widespread pain that can lead to significant patient dysfunction and economic burden to society. The management of patients with fibromyalgia is difficult and no single treatment modality has been successful. We propose to study the effect of dietary soy supplement on quality of life associated with fibromyalgia.


Condition Intervention
Fibromyalgia
 Dietary Supplement: Soy
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Revival Soy on Fibromyalgia Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To gather preliminary data on whether dietary soy supplement can improve quality of life in patients with fibromyalgia as measured by the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D). [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement. [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: September 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soy
A shake that contained 20 g of soy protein and 160 mg of soy isoflavone.
 Dietary Supplement: Soy
Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
Other Names:
  • Soy
  • Isoflavone
Placebo Comparator: Placebo
A shake that contained 20 g of milk-based protein (casein) and no isoflavone.
 Other: Placebo
Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.

Detailed Description:

Fibromyalgia syndrome is a chronic, generalized pain syndrome that affects the musculoskeletal system (1). This syndrome is typically diagnosed in patients who experience generalized musculoskeletal pain and have excessive tenderness in at least 11 of 18 specific points (2). Although the primary cause of fibromyalgia syndrome is unclear, a growing body of evidence indicates that the widespread pain associated with this syndrome is due to abnormalities in the central nervous system. Therefore, drug therapy for fibromyalgia syndrome is most often aimed at the central nervous system and includes tricyclic antidepressants, selective serotonin reuptake inhibitors, dual serotonin and norepinephrine reuptake inhibitors, analgesics, and anticonvulsants (1).

In addition to medical therapies, complementary and alternative medicine therapies have been used to treat fibromyalgia syndrome symptoms (3). Soy is a widely used dietary supplement that has not been previously tested for treating fibromyalgia syndrome.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men age 18 - 76
  • Able to understand and sign a consent form
  • Able to participate fully in all aspects of the study
  • Currently participating in Mayo Clinic's Fibromyalgia Treatment Program

Exclusion Criteria:

  • Pregnant or lactating women
  • Allergy to soy or other study product ingredients
  • Diagnosis of bipolar disorder, schizophrenia or dementia
  • Diagnosis of diabetes mellitus or inflammatory bowel disease
  • Presently on soy product or use of soy within the last 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279942

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Physicians Pharmaceuticals, Inc.
Investigators
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic
  More Information

Publications:

Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00279942     History of Changes
Other Study ID Numbers: 2155-05
Study First Received: January 18, 2006
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Fibromyalgia
Dietary Supplements
Rheumatologic Diseases
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013