Safety and Tolerability of Esterified Phytosterols Administered in Reduced-Fat Spread and Salad Dressing to Healthy Adult Men and Women

Davidson, Michael; Maki, Kevin C.; Umporowicz, Denise M; Ingram, Kate A.; Dicklin, Mary R.; Schaefer, Ernst J.; Lane, Richard W.; McNamara, Judith; Ribaya-Mercado, Judy D.; Perrone, Gayle; Robins, Sander J.; Franke, William

doi:10.1080/07315724.2001.10719051

Cited by 120 publications

(64 citation statements)

References 18 publications

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“…There was no difference in serum vitamins and bcarotene responses between the 2 groups. This finding was similar to those of previous studies (21)(22)(23)(27)(28).…”

Section: : (P<001) Versus Baseline (Student's T-test)supporting

confidence: 83%

“…The only significant changes were increases in serum b-sitosterol and campesterol. Previous studies (6,16,(21)(22)(23)(24), which analyzed the change of serum cholesterol in subjects with normal baseline serum total cholesterol, did not show a fixed trend of response to phytosterol intake. Judd et al (22) reported that the baseline concentration was a significant predictor of the final concentration for all serum lipids and lipoproteins, and that the magnitude of change in serum lipids was the same over all baseline concentrations.…”

Section: : (P<001) Versus Baseline (Student's T-test)mentioning

confidence: 99%

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Effects of Phytosterol Ester-Enriched Vegetable Oil on Serum Cholesterol and Assessment of Safety in Healthy Men.

et al. 2003

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Abstract:The purpose of this study was to determine the effects of phytosterol esterenriched vegetable oil on the serum concentration of cholesterol and to assess its safety in healthy subjects with normocholesterolemics. Twenty-two healthy subjects completed this study in a double blind, parallel arm design. The subjects were randomly divided into 2 groups: control group (n = 11) and phytosterol ester-enriched group (n = 11), and fed either 42 g of phytosterol ester-enriched vegetable oil or control vegetable oil, containing about 1.336 g and 0.117 g of phytosterol (as the major free sterol) respectively, daily for 4 weeks. Serum lipids, apolipoproteins, serum fat-soluble vitamins, serum phytosterols and biochemical parameters were measured. The subjects were asked to report any side effect. Phytosterol ester-enriched vegetable oil significantly reduced the concentrations of serum total cholesterol, low-density lipoprotein cholesterol and apolipoprotein B, by 3.3%, 4.4% and 3.2% respectively, compared with control oil. No significant changes were found in the concentrations of triacylglycerol, high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, remnant-like lipoprotein cholesterol and other kinds of apolipoproteins. Neither vegetable oil affected the concentrations of fat-soluble vitamins (retinol and a-tocopherol) or b-carotene. Serum bsitosterol and campesterol were significantly higher in the phytosterol ester-enriched vegetable oil group compared with the control oil group. The concentrations of biochemical parameters did not change in either group. There were no side effects or serious adverse events in either group during the administration. In conclusion, the results showed that a daily 1.336 g intake of phytosterol (as the major free sterol) is effective in lowering serum total-and LDL-cholesterol in healthy men and has no negative physiologic action.

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“…There was no difference in serum vitamins and bcarotene responses between the 2 groups. This finding was similar to those of previous studies (21)(22)(23)(27)(28).…”

Section: : (P<001) Versus Baseline (Student's T-test)supporting

confidence: 83%

Section: : (P<001) Versus Baseline (Student's T-test)mentioning

confidence: 99%

Effects of Phytosterol Ester-Enriched Vegetable Oil on Serum Cholesterol and Assessment of Safety in Healthy Men.

et al. 2003

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“…Maki et al (26) have reported lowering of TC concentrations by 5.2% and 6.6% with a 50% fat spread providing 1.1 g or 2.2 g phytosterols/day, respectively, compared with a control reduced-fat spread and LDL cholesterol lowering of 7.6 and 8.1%. However, in a trial comparing the effects of 3 g phytosterols/day in a reduced-fat spread versus 6 g phytosterols/day in a 28% fat dressing, and 9 g phytosterols/day provided in reduced-fat spread and dressing (33), there was no difference in cholesterol concentrations in any of the three groups compared with control. Reductions similar to those observed by Davidson et al (33) had previously been observed when using mayonnaise as a vehicle for phytosterol administration (34,35).…”

Section: Discussionmentioning

confidence: 98%

Phytosterols in low- and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels

Jones

Vanstone

Raeini−Sarjaz

et al. 2003

Journal of Lipid Research

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Dietary phytosterols have been shown to reduce plasma cholesterol concentrations when consumed in different food matrices, but their effectiveness in nonfat or low-fat beverages has not been established. The objective of this study was to examine whether phytosterols alter plasma lipid levels when incorporated into nonfat or low-fat beverages. Fifteen moderately hypercholesterolemic men and women consumed three precisely controlled diets for periods of 21 days each in random order. Diets contained either a nonfat placebo beverage (NF), a beverage that is nonfat with added phytosterols (NFPS), or a beverage that is low in fat with added phytosterols (LFPS). Total cholesterol concentrations were not different between groups at endpoint, decreasing ( P Ͻ 0.05) equally by 8.5%, 11.6%, and 10.1% with NF, NFPS, and LFPS consumption, respectively. There was no effect of dietary treatment on LDL cholesterol concentrations, which decreased over time ( P Ͻ 0.05) by 5%, 10.4%, and 8.5% with NF, NFPS, and LFPS, respectively. HDL cholesterol and triacylglycerol concentrations were unaffected by the diets. Provision of phytosterols as part of nonfat and low-fat beverages did not exert any greater hypocholesterolemic effect than a nonfat placebo beverage. These results show that intake of phytosterols in a low-fat beverage format is not efficacious for lipid level modification. Low-fat diets containing less than 30% of energy as fat and less than 10% as saturated fat have long been promoted for lowering plasma cholesterol concentrations in hypercholesterolemic patients. Recently, the National Cholesterol Education Program Adult Treatment Panel III guidelines have added the inclusion of phytosterols as part of their therapeutic lifestyle changes dietary guidelines (1) in addition to the traditional recommendations to lower total fat, saturated fat, and cholesterol intakes.Furthermore, in 2000, the US Food and Drug Administration issued a health claim stating that foods containing plant sterol and stanol esters, when consumed in foods low in saturated fat and cholesterol, reduced the risk of coronary heart disease (2). Phytosterols have traditionally been incorporated into margarines, spreads, and other high-fat foods and have been shown to be efficacious in lowering total cholesterol (TC) and LDL cholesterol (3)(4)(5)(6)(7)(8)(9)(10)(11). In a recent meta-analysis, it was reported that consumption of more than 2 g of phytosterols/day reduced LDL cholesterol concentrations by 0.33 to 0.54 mmol/l, depending on the age of the subjects studied, and that intakes of less than 2 g/day led to reductions in LDL cholesterol of at least 0.4 to 0.5 mmol/l (3). It is thus generally agreed that phytosterol consumption leads to, on average, a 10% reduction in TC and a 13% reduction in LDL cholesterol concentrations.Phytosterols exert their cholesterol-lowering action by suppressing intestinal cholesterol absorption while partially suppressing cholesterol biosynthesis (9, 12, 13). While they are only partially absorbed into the circul...

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“…Formal recommendation of their use for children awaits clinical trial data. 42,[170][171][172][173][174][175][176][177] …”

Section: Therapeutic Lifestyle Changes For Treatment Of Hypertension mentioning

confidence: 99%

Dietary Recommendations for Children and Adolescents: A Guide for Practitioners

Gidding¹,

Dennison²,

Birch³

et al. 2006

Pediatrics

411

128

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Since the American Heart Association last presented nutrition guidelines for children, significant changes have occurred in the prevalence of cardiovascular risk factors and nutrition behaviors in children. Overweight has increased, whereas saturated fat and cholesterol intake have decreased, at least as percentage of total caloric intake. Better understanding of children's cardiovascular risk status and current diet is available from national survey data. New research on the efficacy of diet intervention in children has been published. Also, increasing attention has been paid to the importance of nutrition early in life, including the fetal milieu. This scientific statement summarizes current available information on cardiovascular nutrition in children and makes recommendations for both primordial and primary prevention of cardiovascular disease beginning at a young age.

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Safety and Tolerability of Esterified Phytosterols Administered in Reduced-Fat Spread and Salad Dressing to Healthy Adult Men and Women

Abstract: The results of this study indicate that phytosterol esters are well tolerated and show no evidence of adverse effects at a daily intake of up to 9.0 g of phytosterols for eight weeks.

Cited by 120 publications

References 18 publications

Effects of Phytosterol Ester-Enriched Vegetable Oil on Serum Cholesterol and Assessment of Safety in Healthy Men.

Effects of Phytosterol Ester-Enriched Vegetable Oil on Serum Cholesterol and Assessment of Safety in Healthy Men.

Phytosterols in low- and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels

Dietary Recommendations for Children and Adolescents: A Guide for Practitioners

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