Effect of Revival Soy on Fibromyalgia Pain

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Dietary Supplement: Soy; Other: Placebo

• Registration Number: NCT00279942
• Lead Sponsor: Mayo Clinic

Brief 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.

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.

Study Timeline

• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Study Start: 2006-05
• Primary Completion: 2006-08
• Study Completion: 2006-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soy	Soy	A shake that contained 20 g of soy protein and 160 mg of soy isoflavone.
Placebo	Placebo	A shake that contained 20 g of milk-based protein (casein) and no isoflavone.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement.	3 Months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States