Effect of Revival Soy on Fibromyalgia Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Revival Soy on Fibromyalgia Pain

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: Soy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soy<br>A shake that contained 20 g of soy protein and 160 mg of soy isoflavone. | Dietary Supplement: Soy<br>* Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.<br>* Other names: Isoflavone;|
| Placebo Comparator: Placebo<br>A shake that contained 20 g of milk-based protein (casein) and no isoflavone. | Other: Placebo<br>* Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement. |  | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Dietary Supplements, Rheumatologic Diseases, Complementary and Alternative Medicine