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OpenTrials
Completed

NCT Number: NCT00279942

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.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy

Dietary Supplement

Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.

Other names: Isoflavone

Placebo

Other

Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement.

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Physicians Pharmaceuticals, Inc.

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 20, 2006
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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