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Familial hypercholesterolemia, one form of type IIa hyperlipidemia, usually responds poorly to standard low-lipid diets. To define the responsiveness to a soy-protein diet in this disease, one homozygous and twenty heterozygous type IIa patients were submitted to a 4-wk traditional hypocholesterolemic diet followed by 4 wk in which animal protein was substituted with texturized soy protein. Soy was then withdrawn for a further 4 wk. No significant changes in plasma lipids were observed during low-lipid diets. The soy diet, however, caused a marked decrease in total (-20.8%) and low-density-lipoprotein (-25.8%) cholesterol and in apolipoprotein B (-14.1%). The plasma cholesterol reduction was higher in patients with apolipoprotein E3/E3 or E3/E4 vs an almost negligible effect on E3/E2. These results confirm that soy-protein diets can lower cholesterol in type IIa patients with familial disease. Data on the sensitivity of patients with different apo-E isoforms agree with recent hypotheses suggesting that soy proteins may activate B,E receptors.

SUMMARY After a period of stabilisation on a controlled low lipid low cholesterol diet with animal proteins a group of 16 children with familial hypercholesterolaemia were given a textured soybean protein based diet, with a similar fat composition. All the children had a highly significant reduction in total cholesterol, averaging -21-8% against the baseline after eight weeks. Compliance became less strict afterwards, but more than half of the patients have regularly continued the diet and results have been maintained for one year. Minimal changes were noted in triglyceridaemia and in high density lipoprotein cholesterol concentrations, which showed a slight rise only at the end of treatment. The children's growth during the trial was normal. In view of the psychological difficulties of prescribing treatment with drugs to children with severe hypercholesterolaemia before puberty and of the relative ineffectiveness of standard low lipid diets in this condition the soybean protein diet may offer a satisfactory alternative.Hypercholesterolaemia in childhood poses serious therapeutic problems, in that treatment with drugs, although reported as well tolerated,i often conflicts with the physician's desire to avoid chronic treatments during growth. Dietary studies, on the other hand, characterised by a moderate cholesterol intake with increased polyunsaturated/saturated (P/S) fatty acid ratios, often lead to fairly modest plasma cholesterol reduction.2 3More recently, the observation that switching from a low lipid diet with animal proteins to a similar diet with textured vegetable proteins (TVP) extracted from soybean markedly reduces cholesterolaemia in adult patients with type II hypercholesterolaemia has attracted considerable attention. An attempt to modify the type of dietary proteins in children with hypercholesterolaemia has already been carried out, using a vegetarian type of diet (including 60% animal proteins, mostly from milk) with a high linoleic acid content (P/S ratio 1-6).5 Compared with a 'control' diet, with a similar P/S ratio, this vegetarian diet lowered cholesterolaemia by roughly 10%.As it seems possible, based on our extensive experience in adult patients, to provide a reasonably well accepted dietary regimen, by totally substituting animal proteins with TVP from soybean, now 274provided with added lecithin (L-TVP),P we decided to test this dietary approach in a selected group of type II children. Patients and methodsSixteen prepubertal subjects, with an age range of 3 to 12 years, were included in the study.

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