Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

This study has been terminated.
(recruitment and pilot funding issues)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00693082
First received: June 3, 2008
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS (N=20) will be scheduled for baseline measures and then instructed and given supplies necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months, whereupon follow-up measures will be taken. Subjects will be asked to resume their typical (unsupplemented) diet for another three months and a second set of follow-up measures will be taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall hypothesis (based upon our work in men at risk for prostate cancer and data from one case-study conducted in a woman with confirmed PCOS) is that during the time women receive flaxseed supplementation they will experience reduced serum levels of testosterone, and total and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of this study, statistical analyses will be limited to simple descriptive statistics. We have observed no negative side effects, other than minor gastro-intestinal occurrences (i.e., temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed supplementation will be discontinued if indicated and the events reported to the institutional review board.


Condition Intervention Phase
Polycystic Ovarian Syndrome
Dietary Supplement: flaxseed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS. [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: flaxseed
1 tablespoon a day for first three days, increasing to two tablespoons a day for the next three days. On the 7th day start with 3 tablespoons per day and maintain dose throughout the duration of the study (11 weeks).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • limited to women aged 18-45
  • diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually), Ferriman-Gallwey score > 8, and/or hyperandrogenemia defined as bioavailable T>8.4ng/dL (Zawdaki & Dunaif 1992)
  • mentally competent
  • English speaking/writing
  • telephone access and/or email access

Exclusion Criteria:

  • Use of oral contraceptives, spironolactone or insulin-sensitizing agents within the past 3 months;
  • Long-term or chronic use of oral antibiotics;
  • Diagnoses of hyperprolactinemia, thyroid abnormalities, or nonclassic adrenal hyperplasia;
  • Hysterectomy;
  • Onset of menopause;
  • Pregnancy/Lactation;
  • Consumption of flaxseed within the past month; and
  • Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693082

Locations
United States, North Carolina
Duke Univeristy Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Susan M Schneider, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00693082     History of Changes
Other Study ID Numbers: Pro00000854
Study First Received: June 3, 2008
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
PCOS
flaxseed

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014