Background Daidzein (one of major isoflavones) could be metabolized by gut bacteria and produced equol in certain individuals.Effects of isoflavones alone and equol status on the lipid profile were still controversial.Objective To evaluate the long-term effects of daidzein alone and equoi status on cardiovascular risk factors in hypercholesterolemia individuals.Methods This was a randomized,double-blind,placebo-controlled trial in hypercholesterolemia.Two hundred and ten patients with hypercholesterolemia (age of 40-65 years,fasting total cholesterol higher than 5.18 mmol/liter) were recruited into this clinical trial.The participants were given soy isolated protein (5g/day) added with daidzein 0 mg (control),40mg (DAI40) or 80mg (DA180) intervention for 6 months.Blood lipid profile,glucose,insulin,glycated hemoglobin,and blood uric acid of participants were assayed.Results:Compared to the control group,uric acid significantly decreased by 0.30 mg/dL (95% CI:-0.47,-0.14 mg/dL) and 0.42 mg/dL (95% CI:-0.56,-0.27 mg/dL) in DAI40 and DAI80 groups (p =0.048).No different was found in BMI,blood pressures,total,HDL-and LDL cholesterol,triglycerides,apolipoprotein AI and B,lipoprotein(a),glucose,insulin,homeostasis model assessment for insulin resistance and glycated hemoglobin between groups after intervention.Equol status had no influence on daidzein effects.Conclusions This study suggested that long term consumption of daidzein significantly reduced uric acid and not influenced blood lipid profile and glucose in equol and non-euqol producers with hypercholesterolemia.