Clinical trial NCT00693082: Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
Official title: Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Polycystic Ovarian Syndrome
Keywords: PCOS
flaxseed
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Univeristy Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Susan M Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
References: