References

Clinical Studies

University of Manitoba, Canada

This study proved the efficacy of CARDIOSMILE, a water-dispersible formulation of free plant sterols (WD-PS) versus plant sterol esters (PS esters), thus supporting the claim that there may be additional advantages in a more highly solubilized form of WD-PS in comparison with traditional PS esters in terms of controlling lipid levels.

(*) Shaghaghi M.A., Harding S.V., Jones P.J.H. (2014). Water dispersible plant sterol formulation shows improved effect on lipid profile compared to plant sterol esters. J. Funct. Foods, 6:280-9.

  • Title: Water dispersible plant sterol formulation shows improved effect on lipid profile compared to plant sterol esters.
  • Authors: Mandana Amir Shaghaghi, Scott V. Harding, Peter J.H. Jones.
  • Abstract: While the cholesterol-lowering efficacy of plant sterols (PS) is known, issues surrounding reduced PS solubility of some dietary formulations remain to be elucidated. This study determined the efficacy of a water dispersible formulation of free plant sterols (WD-PS) ver- sus plant sterol esters (PS-esters). Forty-seven mild-to-moderately hypercholesterolemic individuals in a randomized, crossover study were provided for 4 wk with a single-dose daily regimen of PS-enriched yogurt (2 g/d of PS from WD-PS or PS-esters) or placebo. Yogurt enriched with WD-PS or PS-esters induced similar decreases in serum total (7.7% and 6.3%, respectively) and LDL cholesterol levels (11.7% and 11.6%, respectively), as per- centage relative to the control (p < 0.001; all). Ratios of total to HDL cholesterol and non- HDL to HDL cholesterol decreased more (p < 0.05) with WD-PS (10.6% and 15.2%, respec- tively) than with PS-esters (7.0% and 10.8%, respectively) compared with control. Consump- tion of WD-PS reduced serum triglyceride levels (13.9%, p < 0.05) compared to consumption of PS-esters (0.6%). Both WD-PS and PS-esters contributed effectively to LDL cholesterol lowering, however, the formulation of WD-PS yield additional effects on preventing cardio- vascular diseases by improving serum TG and the ratio of total to HDL cholesterol.
    Trial registration (clinicaltrials.gov): NCT01478789.

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University of Los Andes, Chile

This study determined the possible link between a reduction in waist size and triglycerides levels, with an increase in intestinal transit. Waist size and high triglyceride levels have been identified as two of the most relevant risk factors for cardiovascular disease, and become good indicators of the potential efficacy of plant sterols as a plausible treatment for conditions such as metabolic syndrome.

(*) Palmeiro, Y., et al. (2020). Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients, 12(8): 2392.

  • Title: Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial.
  • Authors: Yasna K. Palmeiro-Silva, Raúl I. Aravena, Lisette Ossio and Javiera Parro Fluxa.
  • Abstract: Metabolic syndrome (MS) affects up to 40% of the population and is associated with heart failure, stroke and diabetes. Phytosterols (PS) could help to manage one or more MS criteria. The purpose of this study was to evaluate the therapeutic effect of daily supplementation of an aqueous dispersion of 2 g of free-phytosterols nanoparticles in individuals with MS over six months of intervention, compared with placebo. This double-blind study included 202 participants with MS randomly assigned into phytosterol (n = 102) and placebo (n = 100) groups. Participants were assessed at baseline, 4, 12 and 24 weeks. General health questions, anthropometric measurements and blood parameters were analysed. At week 24, the proportion of participants with high triglycerides (≥150 mg/dL) in the phytosterol group was 15.65% lower than in the placebo group (p-value = 0.023). Similarly, half of the participants in the phytosterol group decreased their waist circumference up to 4 cm compared with 0 cm in the placebo group (p-value = 0.0001). We reported no adverse effects (diarrhoea or vitamin D reduction); nonetheless, almost 70% of participants in the phytosterol group self-reported an improvement in bowel habits. Daily intake of free-PS nanoparticles improved some MS criteria; therefore, it might be a promising adjuvant therapy for individuals with MS (NCT02969720).

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Whitepapers Nutrartis

Nutrartis Dispersible Sterols (NDS) show improved effect on lipid profile compared to plant sterol esters

NDS is a novel plant sterol formulation in which free sterol particles have been downsized and stabilized using a proprietary process. This process improves the clinical efficacy of sterols as shown in the results of a research study carried out at the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Canada.

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Role of phytosterols as antivirals and immunomodulators

Lipids, especially cholesterol and its plant counterpart phytosterols, are key components of cell membranes, hormone precursors and regulators of many biological processes. In this white paper we will expand on the relation between phytosterols as human immuno- modulators and as antiviral.

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