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

January 18, 2006
January 4, 2012
May 2006
August 2006   (final data collection date for primary outcome measure)
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 ]
  • Quality of Life Improvement as measured by the Fibromyalgia Impact Questionnaire (FIQ)
  • Epidemiologic Studies Depression Scale (CES-D)
Complete list of historical versions of study NCT00279942 on ClinicalTrials.gov Archive Site
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 ]
feasibility of recruiting 50 patients with fibromyalgia into a study using a dietary supplement
Not Provided
Not Provided
 
Effect of Revival Soy on Fibromyalgia Pain
Effect of Revival Soy on Fibromyalgia Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Dietary Supplement: Soy
    Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
    Other Names:
    • Soy
    • Isoflavone
  • Other: Placebo
    Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
  • Active Comparator: Soy
    A shake that contained 20 g of soy protein and 160 mg of soy isoflavone.
    Intervention: Dietary Supplement: Soy
  • Placebo Comparator: Placebo
    A shake that contained 20 g of milk-based protein (casein) and no isoflavone.
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279942
2155-05
Yes
Dietlind Wahner-Roedler, Mayo Clinic
Mayo Clinic
Physicians Pharmaceuticals, Inc.
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic
Mayo Clinic
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP