A Phase 2 interventional study of flaxseed in Polycystic Ovarian Syndrome, sponsored by Duke University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-20.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 4 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
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Exclusion Criteria:
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).
To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.
Time frame: baseline, 12 weeks, 24 weeks
This study is terminated, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Duke University