Aims: To evaluate for the first time in children the effect of soy-derived isoflavones on lipid profile and insulin resistance.
Methods: Twelve hypercholesterolemic children (8 females) aged 5.3 to 11.2 years have completed a prospective, controlled pilot study. After a low-fat diet for 12 weeks, children who maintained high cholesterol and low-density lipoprotein-cholesterol (LDL-C) levels were randomly assigned to three intervention periods of either placebo or low and high dose isoflavone (16 or 48 mg) consumption, each period lasting 8 weeks.
Results: The diet significantly reduced LDL-C and apolipoprotein B (Apo B) levels. However, isoflavones had no effect on cholesterol, LDL-C, high-density lipoprotein-cholesterol (HDL-C), triglycerides, lipoprotein (a), Apo B, or insulin resistance, at either low or high doses. Isoflavones had no effect on sex hormones, gonadotropins, sex-hormone binding globulin and thyroid hormones.
Conclusions: The results of this pilot study do not suggest a beneficial role of an isoflavone-enriched diet in children with hypercholesterolemia.