Peterson D. Effect of soybean sterols in the diet on plasma and liver cholesterol in chicks. PSEB 1951;78:143; Sugano M, Kamo F, Ikeda I, Morioka H. Lipid-lowering activity of phytostanols in rats. Atherosclerosis 1976;24:301-9; Sugano M, Morioka H, Ikeda I

2 Animal studies have also found the potential for phytosterols to impact the development of atherosclerosis, or the "clogging" of arteries. Additional studies have further suggested that the damage to arteries caused by atherosclerosis can be reduced by the consumption of phytosterols.

Ikeda I, Kawasaki A, Samezima K, Sugano M. Antihypercholesterolemic activity of beta-sitostanol in rabbits. J Nutr Sci Vitaminol (Tokyo) 1981;27:243-51; Ntanios FY, Jones PJ, Frohlich JJ. Dietary sitostanol reduces plaque formation but not lecithin cholesterol acyl transferase activity in rabbits. Atherosclerosis 1998;138:101-10

3 An extensive program to evaluate the safety of phytosterols concluded that the consumption of phytosterols is safe and free of negative side effects.

Wolfreys AM, Hepburn PA. Safety evaluation of phytosterol esters. Part 7. Assessment of mutagenic activity of phytosterols, phytosterol esters and the cholesterol derivative, 4-cholesten-3-one. Food Chem Toxicol 2002;40:461-70; Baker VA, Hepburn PA, Kennedy SJ, et al. Safety evaluation of phytosterol esters. Part 1. Assessment of oestrogenicity using a combination of in vivo and in vitro assays. Food Chem Toxicol 1999;37:13-22; Waalkens-Berendsen DH, Wolterbeek AP, Wijnands MV, Richold M, Hepburn PA. Safety evaluation of phytosterol esters. Part 3. Two-generation reproduction study in rats with phytosterol esters–a novel functional food. Food Chem Toxicol 1999;37:683-96; Weststrate JA, Ayesh R, Bauer-Plank C, Drewitt PN. Safety evaluation of phytosterol esters. Part 4. Faecal concentrations of bile acids and neutral sterols in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine. Food Chem Toxicol 1999;37:1063-71; Ayesh R, Weststrate JA, Drewitt PN, Hepburn PA. Safety evaluation of phytosterol esters. Part 5. Faecal short-chain fatty acid and microflora content, faecal bacterial enzyme activity and serum female sex hormones in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine. Food Chem Toxicol 1999;37:1127-38

4 More than 40 years of clinical research has consistently demonstrated that the consumption of phytosterols can result in a 5 percent to 15 percent reduction in total cholesterol levels.

Ostlund, RE. Phytosterols in human nutrition. 20002; 22:533-49. Law, MR. Plant sterol and stanol margarines and health. British Medical Journal 2000; 320:861-864.

5 The most recent research on phytosterols has involved observing the effects of blood cholesterol after incorporating the compounds into the diet via food products, like margarines, spreads and oils. In one study, subjects incorporated a reduced-fat spread into a National Cholesterol Education Program (NCEP) Step I diet for a four-week period, followed by a five-week period of that same diet plus either a reduced-fat spread or a reduced-fat spread enriched with plant sterols. The results indicate that participants in the low- and high-sterol groups were able to lower their total cholesterol levels by 5.2 percent and 6.6 percent, respectively. In addition, their LDL-cholesterol levels were 7.6 percent and 8.1 percent lower than the subjects who consumed the reduced-fat spread. This data indicates that the addition of plant sterols to a diet low in saturated fat and cholesterol can offer cholesterol-related benefits on top of what is achieved through dietary changes alone.

Maki KC, Davidson MH, Umporowicz DM, et al. Lipid responses to plant sterol enriched reduced-fat spreads incorporated into a National Cholesterol Education Program Step I diet.PG - 33-43. Am J Clin Nutr 2001;74

6 Another study enlisted 34 male college students with elevated total cholesterol (TC) levels, LDL ("bad") cholesterol levels and the ratio between total cholesterol and high-density lipoprotein (TC:HDL) and assigned them to either a control group, which consumed plain ground beef, or a treatment group, which consumed ground beef with 2.7 g of phytosterols. The group who consumed beef with phytosterols were able to lower their TC and LDL-cholesterol levels as well as TC:HDL cholesterol 9.3 percent, 14.6 percent, and 9.1 percent, respectively.

Matvienko OA, Lewis DS, Swanson M, et al. A single daily dose of soybean phytosterols in ground beef decreases serum total cholesterol and LDL cholesterol in young, mildly hypercholesterolemic men.PG - 57-64. Am J Clin Nutr 2002;76.

7 Studies conducted on subjects with familial hypercholesterolemia (FH), a genetically inherited condition that leads to increased levels (two to three times more) of LDL, or "bad" cholesterol, have also yielded positive results with the consumption of phytosterols. Among those with FH, dietary changes alone cannot sufficiently lower blood cholesterol levels, and cholesterol-lowering drugs are often prescribed. However, studies have shown that dietary changes along with phytosterol-containing products can provide cholesterol-lowering benefits in addition to those produced by the cholesterol-lowering drugs. Many of these studies have been conducted in children with FH and have supported the safe and efficacious use of phytosterols among children.

Vuorio AF, Gylling H, Turtola H, Kontula K, Ketonen P, Miettinen TA. Stanol ester margarine alone and with simvastatin lowers serum cholesterol in families with familial hypercholesterolemia caused by the FH-North Karelia mutation. Arterioscler Thromb Vasc Biol 2000;20:500-6; Gylling H, Siimes MA, Miettinen TA. Sitostanol ester margarine in dietary treatment of children with familial hypercholesterolemia. J Lipid Res 1995;36:1807-12

8 Although the beneficial effects of phytosterols have been seen for decades in subjects with high cholesterol, it was not until recently that scientists began examining the compounds' effects on people with normal cholesterol levels. In one recent study, 95 subjects with normal to mildly high total cholesterol levels at entry had significantly reduced plasma total- and LDL-cholesterol concentrations (8-13 percent) compared to control after ingestion of margarines enriched with soybean oil sterols.

Weststrate JA, Meijer GW. Plant sterol-enriched margarines and reduction of plasma total- and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects.PG - 334-43. Eur J Clin Nutr 1998;52

9 Another recent clinical study fed 100 people with normal to mildly high cholesterol (<200 mg/dL is desirable, 200 - 239 mg/dL is considered borderline high cholesterol and >239 is considered high cholesterol) four spreads, each for 3.5 weeks. The spreads included butter, a commercially available (control) spread and three experimental spreads fortified with three different amounts of plant sterols (0.83, 1.61, 3.24 g/day). All three phytosterol-fortified spreads yielded some decrease in total cholesterol, as well as LDL cholesterol; however, the researchers concluded that as little as 1.6 g of plant sterols per day could provide the maximum cholesterol lowering benefit.

Hendriks HF, Weststrate JA, van Vliet T, Meijer GW. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. Eur J Clin Nutr 1999;53:319-27