Effect of Revival Soy on Fibromyalgia Pain

Fibromyalgia Clinical Trial

Official title:

Effect of Revival Soy on Fibromyalgia Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279942
• Other study ID #: 2155-05
• Status: Completed
• Phase: N/A
• First received: January 18, 2006
• Last updated: January 4, 2012
• Start date: May 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• Soy
Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.

Other:
• Placebo
Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Physicians Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004 Nov 17;292(19):2388-95. Review. — View Citation

Holdcraft LC, Assefi N, Buchwald D. Complementary and alternative medicine in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):667-83. Review. — View Citation

Wahner-Roedler DL, Thompson JM, Luedtke CA, King SM, Cha SS, Elkin PL, Bruce BK, Townsend CO, Bergeson JR, Eickhoff AL, Loehrer LL, Sood A, Bauer BA. Dietary soy supplement on fibromyalgia symptoms: a randomized, double-blind, placebo-controlled, early ph — View Citation

Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 Weeks	No
Secondary	To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement.		3 Months	Yes

External Links

•   Revival Soy