The effects of flaxseed supplementation on metabolic status in women with polycystic ovary syndrome: a randomized open-labeled controlled clinical trial

Randomized open-label controlled clinical trial with two parallel groups. Participants: women with PCOS, aged 18–45 years (Rotterdam criteria). 41 completed; 48 assessed for eligibility; 7 withdrawals. Duration: 12 weeks. Both groups received lifestyle modification; intervention group received flaxseed powder as the supplement.

Brown milled flaxseed powder, 30 g/day, taken daily with meals (e.g., added to salad, yogurt, or cold drinks) for 12 weeks.

Flaxseed powder plus lifestyle modification yielded greater improvements than lifestyle modification alone in insulin metabolism, inflammation, lipids, adipokines, and menstrual regularity among women with PCOS. Compared with baseline and control, significant changes included lower insulin, HOMA-IR, TG, hs-CRP, IL-6, and leptin; higher QUICKI, HDL-C, and adiponectin (p<0.05). Menstrual regularity improved (81% vs 50%, p=0.037). Weight, waist circumference, and BMI decreased modestly. Conclusion: 12 weeks of flaxseed supplementation (30 g/day) with lifestyle modification appears more effective than lifestyle modification alone for multiple metabolic and anthropometric markers in PCOS; supports potential use as a complementary strategy, with further studies needed to clarify mechanisms and dosing.

Open-label design without placebo; small sample size; short duration; single-center; withdrawals and adherence considerations.