The safety evaluation of phytosterol esters. Part 6. The comparative absorption and tissue distribution of phytosterols in the rat

Sanders, David J.; Minter, Helen; Howes, D.; Hepburn, Paul

doi:10.1016/s0278-6915(00)00021-1

Cited by 100 publications

(77 citation statements)

References 20 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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“…Feeding was conducted daily for 10 weeks. An additional 2 weeks of behavioral testing was conducted after BSSG feeding ended (total 12 weeks of testing) to allow blood sterol content to become normalized (Sanders et al 2000;Miettinen et al 1983). At this stage, half the mice were sacrificed.…”

Section: Feeding Of Bssgmentioning

confidence: 99%

Chronic Exposure to Dietary Sterol Glucosides is Neurotoxic to Motor Neurons and Induces an ALS–PDC Phenotype

Tabata

Wilson

et al. 2008

Neuromol Med

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Epidemiological studies of the Guamanian variants of amyotrophic lateral sclerosis (ALS) and parkinsonism, amyotrophic lateral sclerosis-parkinsonism dementia complex (ALS-PDC), have shown a positive correlation between consumption of washed cycad seed flour and disease occurrence. Previous in vivo studies by our group have shown that the same seed flour induces ALS and PDC phenotypes in out bred adult male mice. In vitro studies using isolated cycad compounds have also demonstrated that several of these are neurotoxic, specifically, a number of water insoluble phytosterol glucosides of which β-sitosterol β-D-glucoside (BSSG) forms the largest fraction. BSSG is neurotoxic to motor neurons and other neuronal populations in culture. The present study shows that an in vitro hybrid motor neuron (NSC-34) culture treated with BSSG undergoes a dose-dependent cell loss. Surviving cells show increased expression of HSP70, decreased cytosolic heavy neurofilament expression, and have various morphological abnormalities. CD-1 mice fed mouse NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript chow pellets containing BSSG for 15 weeks showed motor deficits and motor neuron loss in the lumbar and thoracic spinal cord, along with decreased glutamate transporter labelling, and increased glial fibrillary acid protein reactivity. Other pathological outcomes included increased caspase-3 labelling in the striatum and decreased tyrosine-hydroxylase labelling in the striatum and substantia nigra. C57BL/6 mice fed BSSG-treated pellets for 10 weeks exhibited progressive loss of motor neurons in the lumbar spinal cord that continued to worsen even after the BSSG exposure ended. These results provide further support implicating sterol glucosides as one potential causal factor in the motor neuron pathology previously associated with cycad consumption and ALS-PDC.

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“…Nonetheless, in patients on statin therapy, plasma plant sterol and stanol concentrations are two-fold increased . Animal studies have now shown that plant sterols and stanols are incorporated into various tissues like the colon, liver, spleen and heart (Sanders et al, 2000), which may have functional consequences. Indeed, some authors have reported effects of plant sterol and stanol consumption on various kinds of cancers and immune status (as reviewed by de Jong et al, 2003).…”

Section: Introductionmentioning

confidence: 99%

Plant sterol or stanol consumption does not affect erythrocyte osmotic fragility in patients on statin treatment

Jong

Mensink

2006

Eur J Clin Nutr

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Objective: To assess the effects of plant sterol or stanol ester consumption on their incorporation into erythrocytes and their effects on osmotic fragility of red blood cells. Design: Double-blind, randomized, placebo-controlled intervention trial. Subjects and intervention: Forty-one subjects on stable statin treatment -who already have increased serum plant sterol and stanol concentrations -first received for 4 weeks a control margarine. For the next 16 weeks, subjects were randomly assigned to one of three possible interventions. Eleven subjects continued with control margarine, 15 subjects with plant sterol ester enriched and 15 subjects with plant stanol ester-enriched margarine. Daily plant sterol or stanol intake was 2.5 g. Erythrocyte haemolysis was measured spectrophotometrically at five different saline concentrations. Results: Despite significant (P ¼ 0.004) increases of, respectively, 42 and 59% in cholesterol-standardized serum sitosterol and campesterol concentrations in the plant sterol group as compared to the control group, campesterol levels in the red blood cells did not change (P ¼ 0.196). Osmotic fragility did not change significantly (P ¼ 0.757) in the plant sterol and plant stanol groups as compared to the control group. Conclusion: We conclude that plant sterol and stanol ester consumption for 16 weeks does not change osmotic fragility of erythrocytes in statin-treated patients.

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The safety evaluation of phytosterol esters. Part 6. The comparative absorption and tissue distribution of phytosterols in the rat

Cited by 100 publications

References 20 publications

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

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

Chronic Exposure to Dietary Sterol Glucosides is Neurotoxic to Motor Neurons and Induces an ALS–PDC Phenotype

Plant sterol or stanol consumption does not affect erythrocyte osmotic fragility in patients on statin treatment

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