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A Randomized, Placebo-Controlled, Double-Blind Crossover Study to Assess a Unique Phytosterol Ester Formulation in Lowering LDL Cholesterol Utilizing a Novel Virtual Tracking Tool

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Segterra (Inside Tracker), Cambridge, MA 02142, USA
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Nutrasource, Guelph, ON N1G0B4, Canada
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Department of Nutrition, Central Michigan University, Mount Pleasant, MI 48859, USA
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BASF SE, Nutrition and Health, Human Nutrition, 68623 Lampertheim, Germany
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Author to whom correspondence should be addressed.
Nutrients 2019, 11(9), 2108; https://doi.org/10.3390/nu11092108
Received: 18 July 2019 / Revised: 22 August 2019 / Accepted: 26 August 2019 / Published: 5 September 2019
Elevated blood concentration of low-density lipoprotein cholesterol (LDLc) is a primary risk factor for developing cardiovascular disease. Lifestyle interventions including an increase in dietary phytosterols as well as medications have proven effective in lowering LDLc. The primary objective of this randomized, placebo controlled, double blind, crossover study was to determine the impact of a new phytosterol emulsion for dietary supplements (1.5 g/day phytosterol equivalents) on LDLc concentrations. Thirty-two healthy adults were randomly assigned to receive placebo or treatment followed by a washout period, followed by placebo or treatment, each phase lasting one month. Secondary endpoints related to cardiovascular health were also assessed. Study management, including screening, recruitment, monitoring, compliance, and data collection, were done remotely (a siteless clinical trial) utilizing a novel virtual tool. Phytosterol supplementation significantly lowered LDLc concentrations by 10.2% (16.17 mg/dL or 0.419 mmol/L, p = 0.008 by paired t-test, p = 0.014 by Wilcoxon signed rank testing). No secondary biomarkers were found to change significantly. Supplementation with phytosterols in a new dietary supplement formulation efficiently and safely decreases LDLc within one month in a free-living setting. View Full-Text
Keywords: phytosterol; dietary supplement; LDLc; cardiovascular disease risk; lifestyle intervention; site independent nutrition study phytosterol; dietary supplement; LDLc; cardiovascular disease risk; lifestyle intervention; site independent nutrition study
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MDPI and ACS Style

Reaver, A.; Hewlings, S.; Westerman, K.; Blander, G.; Schmeller, T.; Heer, M.; Rein, D. A Randomized, Placebo-Controlled, Double-Blind Crossover Study to Assess a Unique Phytosterol Ester Formulation in Lowering LDL Cholesterol Utilizing a Novel Virtual Tracking Tool. Nutrients 2019, 11, 2108. https://doi.org/10.3390/nu11092108

AMA Style

Reaver A, Hewlings S, Westerman K, Blander G, Schmeller T, Heer M, Rein D. A Randomized, Placebo-Controlled, Double-Blind Crossover Study to Assess a Unique Phytosterol Ester Formulation in Lowering LDL Cholesterol Utilizing a Novel Virtual Tracking Tool. Nutrients. 2019; 11(9):2108. https://doi.org/10.3390/nu11092108

Chicago/Turabian Style

Reaver, Ashley, Susan Hewlings, Kenneth Westerman, Gil Blander, Thorsten Schmeller, Marianne Heer, and Dietrich Rein. 2019. "A Randomized, Placebo-Controlled, Double-Blind Crossover Study to Assess a Unique Phytosterol Ester Formulation in Lowering LDL Cholesterol Utilizing a Novel Virtual Tracking Tool" Nutrients 11, no. 9: 2108. https://doi.org/10.3390/nu11092108

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