Purpose Polycystic ovary syndrome (PCOS) is an endocrine disorder and a common cause of infertility among women that is associated with low-grade inflammation. Therefore, the current randomized, double-blind, placebo-controlled clinical trial was conducted to assess the effects of green cardamom supplementation on the serum level of inflammatory markers and their gene expression among obese women with PCOS. Methods We included 194 obese women with PCOS and administered low-calorie diet to all of them. These subjects were randomly divided into two groups including the intervention group with 3 g/day green cardamom ( n = 99) and the placebo group ( n = 95). Anthropometric indices, androgen hormones, and inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin 6 (IL-6), and C-reactive protein (CRP)] were assessed before and after the 4-month intervention. TNF-α, IL-6, and CRP gene expression levels were measured using reverse transcription-polymerase chain reaction (RT-PCR) method. Results Anthropometric indices were improved in both studied groups ( P < 0.001). Among androgen hormones, luteinizing hormone, androstenedione, and dehydroepiandrosterone were significantly decreased ( P < 0.001), and follicle-stimulating hormone was significantly increased ( P < 0.001) in the green cardamom group. Our findings showed that TNF-α, IL-6, and CRP serum levels were significantly decreased after the intervention with green cardamom plus low-calorie diet ( P < 0.001). In addition, the expression levels of TNF-α and CRP genes were significantly decreased in the intervention group ( P < 0.001). Conclusions The present study supports the beneficial anti-inflammatory effect of green cardamom on the inflammatory state in PCOS women. Level of evidence Level I: randomized clinical trial. Trial registration This trial was registered with the Iranian Clinical Trials Registry (registration number: IRCT20200608047697N1). 1 August, 2020; https://www.irct.ir/trial/48748 .

PurposePolycystic ovary syndrome (PCOS) is a common cause of endocrine disorder and infertility among womenin which is related with low grade inflammation. Therefore, this current randomized, double-blind, placebo-controlledclinical trial assessed the effects of green cardamom supplementation on inflammatory markers and gene expressionamong obese women with PCOS.MethodsWe included 194 obese PCOS women that gave all of them low calorie diet. These subjects were randomlydivided in two studied groups including intervention with 3 g/day green cardamom (n=99) and placebo groups (n=95).Anthropometric indices, androgen hormones, and inflammatory factors (tumor necrosis factor-a (TNF-α), Interleukin6 (IL-6), and C- reactive protein (CRP)) were assessed before and after four months intervention. Their TNF-α, IL-6,and CRP genes expression level were measured using reverse transcription-polymerase chain reaction (RT-PCR)method.ResultsAnthropometric indices were improved in both two studied groups (P<0.001). Among androgen hormonesluteinizing hormone, androstenedione, and dehydroepiandrosterone were significantly decreased (P<0.001), as wellas, follicle-stimulating hormone was significantly increased (P<0.001) in the green cardamom group. Our findingsshowed that TNF-α, IL-6, and CRP serum were significantly decreased after the intervention with green cardamomplus low calorie diet (P<0.001). In addition, the expression level of TNF-α and CRP genes were significantly decreasedin intervention groups (P<0.001).ConclusionsThis present study support the beneficial anti-inflammatory effect of green cardamom on theinflammatory status in the PCOS women.Level of evidenceLevel I, randomized clinical trialTrial registrationThis trial was registered with the Iranian Clinical Trials Registry (registration number:IRCT20200608047697N1). 1 August, 2020; https://www.irct.ir/trial/48748