Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

• ClinicalTrials.gov Identifier: NCT00693082
• Recruitment Status: Terminated
• First Posted: June 6, 2008
• Last Update Posted: November 20, 2012
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: June 3, 2008
• First Posted Date: June 6, 2008
• Last Update Posted Date: November 20, 2012
• Study Start Date: August 2007
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 5, 2008): To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS. [ Time Frame: baseline, 12 weeks, 24 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
• Official Title: Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Polycystic Ovarian Syndrome

Intervention

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).

Study Arms

Experimental: 1

Intervention: Dietary Supplement: flaxseed

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 19, 2012): 4
• Original Estimated Enrollment (submitted: June 5, 2008): 20
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00693082
• Other Study ID Numbers: Pro00000854
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Duke University
• Original Responsible Party: Susan Schneider, PhD, Duke University School of Nursing
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Susan M Schneider, PhD; Duke University

• PRS Account: Duke University
• Verification Date: November 2012