Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

Polycystic Ovarian Syndrome Clinical Trial

Official title:

Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00693082
• Other study ID #: Pro00000854
• Status: Terminated
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: November 19, 2012
• Start date: August 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• 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).

Locations

Country	Name	City	State
United States	Duke Univeristy Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.		baseline, 12 weeks, 24 weeks	No