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Safety of long-term consumption of plant sterol esters-enriched spread.
Eur J Clin Nutr. 2003 May; 57(5):681-92.EJ

Abstract

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 LDL-cholesterol, 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 alpha- and beta-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 (micro mol/mmol total cholesterol) for campesterol (P<0.0001) and from 1.86 to 2.47 (micro mol/mmol total cholesterol) for beta-sitosterol (P<0.0001). The increase in total plant sterol concentration in red blood cells (5.29-9.62 micro g/g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, beta-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.

Authors+Show Affiliations

TNO Nutrition and Food Research, Department of Nutritional Physiology, Zeist, The Netherlands. hendriks@voeding.tno.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

12771969

Citation

Hendriks, H F J., et al. "Safety of Long-term Consumption of Plant Sterol Esters-enriched Spread." European Journal of Clinical Nutrition, vol. 57, no. 5, 2003, pp. 681-92.
Hendriks HF, Brink EJ, Meijer GW, et al. Safety of long-term consumption of plant sterol esters-enriched spread. Eur J Clin Nutr. 2003;57(5):681-92.
Hendriks, H. F., Brink, E. J., Meijer, G. W., Princen, H. M., & Ntanios, F. Y. (2003). Safety of long-term consumption of plant sterol esters-enriched spread. European Journal of Clinical Nutrition, 57(5), 681-92.
Hendriks HF, et al. Safety of Long-term Consumption of Plant Sterol Esters-enriched Spread. Eur J Clin Nutr. 2003;57(5):681-92. PubMed PMID: 12771969.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of long-term consumption of plant sterol esters-enriched spread. AU - Hendriks,H F J, AU - Brink,E J, AU - Meijer,G W, AU - Princen,H M G, AU - Ntanios,F Y, PY - 2002/07/19/accepted PY - 2003/5/29/pubmed PY - 2003/9/4/medline PY - 2003/5/29/entrez SP - 681 EP - 92 JF - European journal of clinical nutrition JO - Eur J Clin Nutr VL - 57 IS - 5 N2 - 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 LDL-cholesterol, 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 alpha- and beta-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 (micro mol/mmol total cholesterol) for campesterol (P<0.0001) and from 1.86 to 2.47 (micro mol/mmol total cholesterol) for beta-sitosterol (P<0.0001). The increase in total plant sterol concentration in red blood cells (5.29-9.62 micro g/g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, beta-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. SN - 0954-3007 UR - https://www.unboundmedicine.com/medline/citation/12771969/Safety_of_long_term_consumption_of_plant_sterol_esters_enriched_spread_ L2 - http://dx.doi.org/10.1038/sj.ejcn.1601598 DB - PRIME DP - Unbound Medicine ER -