Effects of a High-Phytosterol Diet on blood lipids, glucose and estimated 10-year cardiovascular disease risk among Chinese adults with dyslipidemia: a randomized controlled trial

<strong>Background</strong><strong>: </strong>Phytosterols are known for their cholesterol-lowering properties, yet the comparative effects of high-phytosterol diet (HPS diet) and low-phytosterol diet (LPS diet) on blood lipids, fasting blood glucose (FBG) and estimated 10-year cardiovascular disease risk (estimated 10-y CVD risk) in Chinese adults with dyslipidemia remain largely unknown.<strong>Objective: </strong>This trial was to investigate the effects of HPS diet on blood lipids, FBG and estimated 10-y CVD risk in Chinese adults with dyslipidemia compared with LPS diet. <strong>Methods: </strong>A three-month, outcome assessor-blinded, randomized controlled feeding trial was conducted in Chinese adults with dyslipidemia. 104 participants were randomly assigned to either the HPS diet group (<em>n</em> = 52, use HPS cooking oil) or the LPS diet group (<em>n</em> = 52, use LPS cooking oil) after a 2-week run-in period. The primary outcomes were serum total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), Non-high-density lipoprotein cholesterol (NON-LDL-C). Secondary outcomes included FBG and estimated 10-y CVD risk. <strong>Results: </strong>All participants were included in the intention-to-treat (ITT) analysis. After three months of intervention, serum TC (adjusted mean difference = -0.44 mmol/L; 95% CI: -0.67 to -0.20), TG (adjusted mean difference = -1.01 mmol/L; 95% CI: -1.67 to -0.35), LDL-C (adjusted mean difference = -0.25 mmol/L; 95% CI: -0.50 to -0.01) , Non-HDL-C (adjusted mean difference = -0.46 mmol/L; 95% CI: -0.73 to -0.19) and FBG (adjusted mean difference = -0.14 mmol/L; 95% CI: -0.28 to -0.002) were significantly lower in the HPS diet group compared to the LPS diet group (<em>P </em>&lt; 0.05). Additionally, compared to the LPS diet group, the estimated 10-y CVD risk attributed to TC, BMI and all factors in the HPS diet group after intervention decreased by 0.10%, 0.13% and 0.97%, respectively. Sensitivity analysis showed that the main results from the per-protocol population were consistent with the ITT population. <strong>Conclusions: </strong>The HPS Chinese diet significantly lowers blood lipids, FBG and the estimated 10-y CVD risk in Chinese adults with mild dyslipidemia. These findings highlight potential cardiovascular health benefits associated with increased phytosterol intake in daily diets. Further long-term studies are warranted. <strong>Clinicaltrials.gov ID</strong>: NCT06060509