Table 1.

Summary of studies.

Reference	Study Type	Objectives	Main Results
Demonty et al. (2009) [66]	Meta-analysis of randomized controlled trials in adults treated with plant sterols without a co-intervention. Consumption of plant sterol-enriched foods or supplements could not be isolated	Establish a continuous dose–response relationship that would allow predicting the LDL-C-lowering efficacy of different plant sterol doses.	The dose–response equation predicts an LDL-C-lowering effect of 9% for the recommended 2 g/day dose of plant sterols. The continuous dose–response relationship for the LDL-C-lowering effect and plant sterol intake achieved a plateau when it came to approximately 3 g/day.
Gylling et al. (2013) [67]	Randomized, controlled, double-blind, parallel trial including 92 asymptomatic subjects (35 men and 57 women, mean age of 50.8 ± 1.0). The subjects consumed 3 g of plant stanols daily through rapeseed oil-based enriched spread for 6 months.	Evaluate the effects of plant stanol esters on arterial stiffness and endothelial function in adults without lipid medication.	LDL-C decrease of 10% and reduction of arterial stiffness in small arteries and marker of subclinical atherosclerosis (cardio-ankle vascular index—CAVI)
Ras et al. (2014) [12]	Meta-analysis of randomized controlled studies in adults. In total, 124 human studies with a total of 201 study arms were included. Plant sterols and stanols were administered in 129 and 59 study arms, respectively; in the remaining 13 study arms, a mix of plant sterols and stanols was administered.	To investigate the combined and isolated effects of plant sterols and stanols by evaluating different dose ranges.	The average phytosterol (comprising plant sterols and plant stanols) dose 2.1–3.3 g/day were found to gradually reduce LDL-C concentrations by 6%–12%.
Matvienko et al. (2002) [68]	Triple-blind, 34 male college students with elevated total plasma cholesterol (TC), LDL-C, and TC:HDL-C. Randomized: control (ground beef alone) or treatment (ground beef with 2.7 g of plant sterols) group.	Test the hypothesis that a single daily dose of soybean plant sterols added to ground beef would lower TC and LDL-C concentrations in mildly hypercholesterolemic young men.	TC, LDL-C, and TC:HDL-C were reduced from baseline by 9.3%, 14.6%, and 9.1%, respectively.
Assmann et al. (2006) [71]	Case–control study using stored samples from male participants in the Prospective Cardiovascular Münster (PROCAM)	Evaluate if modest sitosterol elevations observed in the general population is associated with the occurrence of coronary events.	Among men with an absolute coronary risk ≥20% in 10 years, high sitosterol concentrations were associated with an additional 3-fold increase in the incidence of coronary events; a similar, significant relationship was observed between a high sitosterol/cholesterol ratio and coronary risk
Mussner et al. (2002) [69]	Randomized, double-blind, placebo-controlled, cross-over study including 63 healthy subjects (38 women, 25 men, mean age of 42 years old, LDL-C of 130 mg/dL)	Comparison of effects from the intake of a plant sterol-enriched margarine and a control margarine.	Plant sterol ester-enriched margarine significantly changed TC, LDL-C HDL-C, apolipoprotein B, and the LDL-C/HDL-C ratio compared to the control margarine
Wilund et al. (2004) [75]	Human subjects from the Dallas Heart Study, 2542 subjects aged 30 to 67 years, were included. Wild-type hypercholesterolemic female mice were also studied.	Determine whether elevated plasma levels of plant sterols were associated with coronary atherosclerosis humans and mice.	Plasma levels of cholesterol, but not of plant sterols, were significantly higher in subjects with coronary atherosclerosis.
Pinedo et al. (2007) [76]	Case–control study among participants of the EPIC-Norfolk Study. Only individuals who did not report a history of heart attack or stroke at the baseline clinic visit were considered.	Evaluate the relationship between plant sterol levels and coronary artery disease risk	Higher levels of plant sterols are unlikely to confer increased risk of coronary artery disease in healthy adults.
Williams et al. (1999) [77]	Open cross-over randomized study lasting 13 weeks; eligible children started either with the diet phase A (plant stanol ester) or B (wheat bran fiber). The first diet phase lasted 4 weeks, and then they went under a two-week wash-out followed by a cross-over to the other diet for 4 weeks.	Evaluate the effects of plant stanol ester in healthy two- to five-year-old preschool children.	Reductions in TC and in LDL-C by 12.4% and 15.5%, respectively, from baseline were observed. There were no significant changes in HDL-C or triglyceride levels.
Guardamagna et al. (2011) [78]	Interventional study using plant sterol-enriched yoghurt for 12 weeks in 32 children with heterozygous familial hypercholesterolemia (FH), 13 children with familial combined hyperlipidemia (FCH), and 13 children with undefined hypercholesterolemia (UH).	To access the efficacy, tolerability, and safety of plant sterol supplementation in children with primary hyperlipidemia.	LDL-C was significantly reduced in the three groups of different forms of primary hyperlipidemia (10.7%, 14.2%, and 16.0% in FH, FCH, and UH, respectively). High tolerability to the diet was observed.
Becker et al. (1993) [79]	Interventional study in 9 children with severe familial hypercholesterolemia. Firstly, there was a 3-month strict diet, followed by the intake sitosterol pastilles (2 g three times a day) for 3 months, and then a 7-month course of sitostanol (0.5 g three times a day).	Set the efficacy difference between sitostanol, a nonabsorbable plant sterol, and sitosterol to reduce serum levels of lipids in children with severe familial hypercholesterolemia.	Sitostanol was significantly more effective in reducing elevated levels of LDL-C than sitosterol (32%).
Amundsen et al. (2002) [80]	Randomized, double-blind crossover study with 38 children (aged 7–12 years) with familial hypercholesterolemia (FH) consuming plant sterol ester enriched spread or a control spread.	Access the effects of plant sterol ester enriched spread intake on serum lipids in children with FH.	Compared to the control group, a consumption of 1.6 g of plant sterol esters promoted a 10.2% reduction in LDL-C concentrations.
de Jongh et al. (2003) [81]	Double-blind crossover trial using plant sterol enriched spreads and a placebo spread. Forty-one children (aged 5–12 years) with familial hypercholesterolemia (FH) were included in this study.	Evaluate the effect of plant sterols on cholesterol levels and vascular function in prepubertal children with FH.	Compared to the placebo group, the intake of 2.3 g plant sterols per day decreased 11% of TC and 14% of LDL-C.
Jakulj et al. (2006) [82]	Double-blind crossover trial testing low-fat yogurt enriched with plant stanols and low-fat placebo yogurt for 4 weeks. The study enrolled 42 prepubertal children with familial hypercholesterolemia (FH).	Evaluate the effects of plant stanols on lipids and endothelial function in prepubertal children with FH.	The group that consumed plant stanols showed a reduction of 9.2% in LDL-C levels without changes in endothelial function.
Ribas et al. (2017) [83]	Randomized, double-blind, cross-over trial using phytosterol-enriched milk and skim milk. Twenty-eight dyslipidemic children (aged 6-9 years) were included in this study.	Investigate the effects of daily consumption of a phytosterol-enriched milk on the lipid profiles of children with dyslipidemia.	The concentrations of TC and LDL-C were significantly reduced in the phytosterol-enriched milk group as compared to the skim milk group, with reductions of 5.9% and 10.2%, respectively.