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

Weststrate, J.A.; Ayesh, R.; Bauer-Plank, Christina; Drewitt, P.

doi:10.1016/s0278-6915(99)00102-7

Cited by 96 publications

(66 citation statements)

References 27 publications

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“…Consumption of plant sterol esters-enriched spread appeared to have no adverse side effects, defined as reported adverse events or undesirable changes in clinical chemical parameters, hematological parameters and urinalysis. The absence of side effects is in agreement with the observations in earlier, shorter-term, clinical and safety studies (Hendriks et al, 1999;Weststrate & Meijer, 1998;Baker et al, 1999;Hepburn et al, 1999;Waalkens-Berendsen et al, 1999;Weststrate et al, 1999;Ayesh et al, 1999;Sanders et al, 2000;Miettinen et al, 1995;Hallikainen et al, , 2000a Safety of plant sterol esters-enriched spread HFJ Hendriks et al 1999; Denke, 1995, Jones et al, 2000Sierksma et al, 1999;Tammi et al, 2000;Vuorio et al, 2000;Nguyen et al, 1999;Blair et al, 2000). Plant sterols are slightly absorbed ( < 5%) and could subsequently be exchanged with cholesterol in an equilibrium fashion in various sterol pools, including cell membranes.…”

Section: Discussionsupporting

confidence: 81%

“…Animal and human studies have shown that plant sterol esters are non-toxic (Baker et al, 1999;Hepburn et al, 1999;Waalkens-Berendsen et al, 1999;Weststrate et al, 1999;Ayesh et al, 1999;Sanders et al, 2000), indicating that these compounds are safe. Human studies, however, have focused on efficacy mainly with a general lack of long-term safety data.…”

Section: Introductionmentioning

confidence: 99%

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Safety of long-term consumption of plant sterol esters-enriched spread

et al. 2003

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Objective: To evaluate both efficacy and safety in humans of long-term consumption of spreads containing plant sterol esters. Design: Randomized double-blind placebo-controlled parallel trial. Subjects: Hundred and eighty-five healthy volunteers (35 -64 y). Intervention: Volunteers daily consumed 20 g spread enriched with 1.6 g plant sterols as fatty acid esters or a control spread for 1 y. They continued their habitual diet and lifestyle. Outcome measures included efficacy markers such as total and LDLcholesterol, a large range of safety parameters, and reporting of adverse events. Results: Consumption of the plant sterol ester-enriched spread consistently lowered total and LDL cholesterol during the 1 y period on average by 4 and 6%, respectively (0.01 < P < 0.05). Plant sterols intake did on average not result in a lower carotenoid concentration (when expressed per LDL-cholesterol) after 52 weeks (P > 0.05). However, carotenoid concentrations changed over time. Plant sterols intake reduced lipid adjusted a-and b-carotene-concentrations by only 15 -25% after 1 y, relative to control. Lipid-adjusted fat-soluble vitamin concentrations remained unchanged. Plant sterol concentrations in serum were increased from 2.76 to 5.31 (mmol=mmol total cholesterol) for campesterol (P < 0.0001) and from 1.86 to 2.47 (mmol=mmol total cholesterol) for b-sitosterol (P < 0.0001). The increase in total plant sterol concentration in red blood cells (5.29 -9.62 mg=g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, b-estradiol and progesterone) as well as all clinical chemical and hematological parameters measured were unaffected. Adverse events reported were not different between subjects consuming control spread and subjects consuming plant sterol esters-enriched spread. Conclusion: Consumption of a plant sterol esters-enriched spread is an effective way to consistently lower blood cholesterol concentrations and is safe to use over a long period of time.

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Safety of long-term consumption of plant sterol esters-enriched spread

et al. 2003

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“…This replacement causes a reduction of micellar cholesterol concentrations and, consequently, lowers cholesterol absorption (6,17,21,59). The unabsorbed cholesterol is excreted in the faeces, increasing its concentration at this level (74) and, therefore, its elimination from the body. This proposed mechanism implies that phytosterols should be consumed with each cholesterol-containing meal to achieve maximal effectiveness.…”

Section: Plant Sterols and Stanols As Cholesterollowering Agentsmentioning

confidence: 99%

Role of naturally-occurring plant sterols on intestinal cholesterol absorption and plasmatic levels

et al. 2009

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Cardiovascular disease is a major health problem in developed countries although its incidence is relatively lower in Mediterranean countries which is partly ascribed to dietary habits. Epidemiologic evidence shows that elevated serum cholesterol, specifically low-density lipoprotein cholesterol (c-LDL), increases cardiovascular disease. Phytosterols are bioactive compounds, found in all vegetable foods, which inhibit intestinal cholesterol absorption and, therefore, have a serum cholesterol-lowering effect. Intestinal cholesterol absorption is a multistep process where plant sterols and stanols may act: a) attenuating the NPC1L1 gene expression, which may result in a lower cholesterol uptake from the lumen; b) lowering the cholesterol esterification rate by the ACAT2 (acyl-CoA cholesterol acyltransferase) and, consequently, the amount of cholesterol secreted via the chylomicrons and c) upregulating the expression of ABC-transporters ABCG5 and ABCG8 in intestinal cells, which may result in an increased excretion of cholesterol by the enterocyte back into the lumen. Many clinical trials proved that commercial products enriched with phytosterols reduce cholesterol levels. Likewise, recent studies show that phytosterols present in natural food matrices are also effective and could be an important component of cardioprotective dietary patterns such as the Mediterranean diet.

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“…Thus, cholesterol-lowering strategies could result in a substantial health benefit at a population level. In many clinical trials, it has been reported that phytosterols or -stanols, when consumed over 1 g per day, induce a significant reduction of serum total cholesterol and lowdensity lipoprotein (LDL) cholesterol concentration (Law, 2000, Miettinen et al, 1995, Weststrate and Meijer, 1998, Hendriks et al, 1999and Hallikainen et al, 2000. Dosages of 1.5-3 g phytosterols and -stanols per day were shown to reduce total serum cholesterol by 8-17% and LDL cholesterol by 9-19% (Amundsen et al, 2002), whereas high-density lipoprotein (HDL) cholesterol concentrations remained unaffected.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of customary use of phytosterol/-stanol enriched margarines on blood cholesterol lowering

Wolfs

Jong

Ocké

et al. 2006

Food and Chemical Toxicology

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Postlaunch monitoring of functional foods can encompass monitoring of effectiveness under conditions of customary use. To this end, the effectiveness of phytosterol/-stanol enriched margarine consumption in free-living conditions was investigated with data from the Dutch "Doetinchem cohort study". In total, 4505 subjects (aged 26-70 years) were examined in 1994-1998 and re-examined during 1999-2003. A general and a food frequency questionnaire and non-fasting blood samples for total and HDL cholesterol determination were obtained. Subjects were stratified into phytosterol/-stanol enriched margarine users (n = 84) and non-users (n = 4421) based on the re-examination data, as these margarines were available on the Dutch market from 1999 onwards.Mean spontaneous daily use (g ± SD) of phytosterol-containing margarine (n = 71) was 15 ± 8 and of phytostanol-containing margarine (n = 13) 9 ± 6. After five years, total blood cholesterol had increased with 0.26 mmol/l in non-users while it had not significantly changed in users. The difference in total blood cholesterol change in users versus non-users was −0.30 mmol/l (p < 0.001). The beneficial effect of the phytosterol/-stanol enriched margarine, used under customary conditions can be characterized as a stabilization of cholesterol levels. This is the first report finding a modest beneficial effect on blood cholesterol level under customary conditions thereby partly confirming findings from clinical trials.

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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

Cited by 96 publications

References 27 publications

Safety of long-term consumption of plant sterol esters-enriched spread

Safety of long-term consumption of plant sterol esters-enriched spread

Role of naturally-occurring plant sterols on intestinal cholesterol absorption and plasmatic levels

Effectiveness of customary use of phytosterol/-stanol enriched margarines on blood cholesterol lowering

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