Trial | NCT00279942  Report issue

Official Title

Effect of Revival Soy on Fibromyalgia Pain

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    soybean ...

  • Study Participants

    50
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.
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 Started
May 31
2006
Primary Completion
Aug 31
2006
Study Completion
Sep 30
2006
Last Update
Jan 06
2012
Estimate

Dietary Supplement Soy

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

  • Other names: Isoflavone

Other Placebo

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

Soy Active Comparator

A shake that contained 20 g of soy protein and 160 mg of soy isoflavone.

  • Dietary Supplement Soy

Placebo Placebo Comparator

A shake that contained 20 g of milk-based protein (casein) and no isoflavone.

Criteria 

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
No Results Posted