Effect of Revival Soy on Fibromyalgia Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-09-30

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.

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Soy

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

Group Type ACTIVE_COMPARATOR

Soy

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Soy

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Isoflavone

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No