• Quality of Life Improvement as measured by the Fibromyalgia Impact Questionnaire (FIQ)
  
• Epidemiologic Studies Depression Scale (CES-D)
  

• feasibility of recruiting 50 patients with fibromyalgia into a study using a dietary supplement
  

Background: 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. Primary Aim: 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 (CCES-D). Secondary Aim: To assess the feasibility of recruiting 50 fibromyalgia patients into a study of using a dietary supplement. Hypothesis:

Supplementation of a soy supplement (Revival Soy) to the diet will help alleviate pain and improve quality of life in sufferers of fibromyalgia. Research Design and Method: The study will be conducted as a randomized, double-blind, placebo-controlled trial. Patients will be recruited from the population of fibromyalgia patients who have been invited and agreed to participate in a 1.5 day multidisciplinary fibromyalgia outpatient program at Mayo Clinic/Rochester. Inclusion Criteria: 1. Female and male patients with fibromyalgia 2. Age 20-70 3. Willing to participate in our 1.5 day fibromyalgia treatment program (FTP) and therefore fulfilling the ACR criteria for the diagnosis of fibromyalgia 4. Able to participate fully in all aspects of the study 5. Able to read and sign the informed consent Exclusion Criteria: 1. Diagnosis of a bipolar disorder, schizophrenia or dementia 2. Diagnoses of Diabetes Mellitus, Inflammatory bowel disease 3. Allergy to soy or other study product ingredients 4. Presently on soy product use of soy within last 30 days 5. Pregnant women (a urine pregnancy test will be performed in all women of childbearing age who are not using any birth control). Eligible study participants will be enrolled in the study and randomized to either Revival soy or Placebo (1 shake a day for 6 weeks). Participants will be asked to complete the FIQ and CES-D at the beginning of the study. They will receive weekly telephone calls by the study coordinator to check on compliance and potential questions and problems. After 6 weeks of daily consumption of the shake/placebo the participants will mail in a second completed FIQ and CES-D and all product wrappers. The primary endpoints for this study are overall functional and health status and depression as measured by the FIQ and CES-D.

The primary analysis for this study will be to compare scores of the FIQ and CES-D between patients receiving Revival Soy and those receiving Placebo in addition to standard care at baseline and 6 weeks.