NCT00279942

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

January 18, 2006

Last Update Submit

January 4, 2012

Conditions

Fibromyalgia

Keywords

FibromyalgiaDietary SupplementsRheumatologic DiseasesComplementary and Alternative Medicine

Outcome Measures

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).

    6 Weeks

Secondary Outcomes (1)

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

    3 Months

Study Arms (2)

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.

Other: Placebo

Interventions

SoyDIETARY_SUPPLEMENT

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

Also known as: Isoflavone
Soy
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

  • Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004 Nov 17;292(19):2388-95. doi: 10.1001/jama.292.19.2388.

    PMID: 15547167BACKGROUND

  • Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

    PMID: 2306288BACKGROUND

  • Holdcraft LC, Assefi N, Buchwald D. Complementary and alternative medicine in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):667-83. doi: 10.1016/s1521-6942(03)00037-8.

    PMID: 12849718BACKGROUND

  • Wahner-Roedler DL, Thompson JM, Luedtke CA, King SM, Cha SS, Elkin PL, Bruce BK, Townsend CO, Bergeson JR, Eickhoff AL, Loehrer LL, Sood A, Bauer BA. Dietary soy supplement on fibromyalgia symptoms: a randomized, double-blind, placebo-controlled, early phase trial. Evid Based Complement Alternat Med. 2011;2011:350697. doi: 10.1093/ecam/nen069. Epub 2011 Jun 23.

    PMID: 18990724RESULT

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Isoflavones

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dietlind L. Wahner-Roedler, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2006

Study Completion

September 1, 2006

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

US(1)