White Paper: Nutrartis Dispersible Sterols (Cardiosmile ) show improved effect on lipid profile compared to plant sterol esters

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1 White Paper: Nutrartis Dispersible Sterols (Cardiosmile ) show improved effect on lipid profile compared to plant sterol esters

2 INTRODUCTION Cardiosmile 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. The full text can be viewed at Journal of Functional Foods 6 (2014) BACKGROUND Cardiovascular diseases cause a third of all deaths globally (WHO, 2011). To optimize blood lipid levels, which are correlated with cardiovascular disease, several advisory bodies have recommended daily consumption of 2 g of plant sterols, which have been proven to lower LDL (American Diabetes Association, 2008; Health Canada, 2010; NCEP, 2001). Unfortunately, enrichment of foods with plant sterols is not straightforward since they are insoluble in water and poorly soluble in fats and oils (Berger et al., 2004). Traditionally, fat solubility of sterols has been improved through an esterification process with fatty acids rendering sterol esters, which can be added into fat-based foods such as spreads and margarine (Fornari et al., 2009). THE NEED FOR ASSURED EFFICACY Properly formulated free sterols may also induce an LDL lowering effect (Richelle et al., 2004), but some formulations have been shown to be effective, while others have not. This observation suggests that formulation and delivery form of free sterols is one of the main causes for inconsistencies in efficacy (Berger et al., 2004). Therefore, it is very important to assess every sterol formulation in order to assure bioavailability and efficacy. STUDY OBJECTIVE The objective of the clinical study was to determine the efficacy on serum lipids concentrations of Nutrartis Dispersible Sterols (Cardiosmile ), a novel free sterol formulation, compared against a positive control (sterol ester) and placebo. DESIGN Volu teers i lusio riteria o prised LDL above 108 mg/dl and Triglycerides below 400 mg/dl, but were excluded if they took statins, nicotinic acid, or fibrates. Subjects who were diagnosed to have diabetes mellitus, sitosterolemia, heart disease, liver disease, kidney disease, or who had recently undergone major surgery were also excluded. Forty seven (47) healthy subjects with mildto-moderate hypercholesterolemia completed the study. Their baseline characteristics are shown in the table below:

3 Change relative to placebo (%) Variable Mean Age (yrs) 50 Body weight (kg) 80.4 Height (cm) BMI (Kg/m2) 28.2 Total cholesterol (mg/dl) LDL cholesterol (mg/dl) HDL cholesterol (mg/dl) 54.2 Triglycerides (mg / dl) The study was a free-living, randomized, crossover trial consisting of three 29-day treatment phases each separated by 4-week washout intervals. Subjects under treatment either were given sterols in free form (Cardiosmile ) or esterified (sterol esters), as a daily dose of 2 g of equivalent free sterols. They were assigned to receive yogurt with Cardiosmile, yogurt with sterol esters, or a placebo, in random order. During each treatment period subjects were instructed to follow their normal diet and consume their standardized supper meal followed by the ingestion of the treatment product. RESULTS Supplementation of both Cardiosmile and sterol esters improved serum lipoprotein profiles. Cardiosmile was shown to further reduce the ratio of Total to HDL, which is considered as a better predictor of CVD events than is total cholesterol or any individual lipid measurement (Assmann, Schulte, von Eckardstein, & Huang, 1996). Notably, Triglycerides were also reduced due to consumption of Cardiosmile, but not sterol esters. These results are shown in the chart below: 5,0 0,0-5,0-10,0-15,0-20,0 Total LDL Non-HDL HDL Triglycerides Total : HDL cholesterol ratio Non-HDL : HDL cholesterol ratio Cardiosmile NDS -7,7-11,7-11,1 2,7-13,9-10,6-15,2 Sterol ester -6,3-11,6-8,7 0,0 0,6-7,0-10,8

4 Lipid profile comparison between treatments with Cardiosmile and sterols esters. It was additionally shown that neither intervention had an effect on fat-soluble vitamins or carotenoids. CARDIOSMILE IMPROVES LIPID PROFILE Although recent analysis demonstrated that free sterols and sterol esters incorporated into foods have a similar cholesterol lowering action (Demonty et al., 2009), conflicting results in some studies (Jones, Vanstone, Raeini-Sarjaz, & St-Onge, 2003) point to the fact that proper formulation of sterols is essential to assure efficacy (Ostlund et al., 1999). This head to head comparison between two different formulations of sterols showed two things: Cardiosmile is a suitable free sterol formulation in view of its LDL lowering effect. Consumption of Cardiosmile was associated with additionally optimizing the blood lipid profile of the parti ipa ts, ith spe ial emphasis on the Total to HDL cholesterol ratio and triglyceride levels, which are considered important markers for the primary prevention of cardiovascular disease (Genest et al., 2009). Conclusion Consumption of Cardiosmile enriched yogurt not only decreased total and LDL cholesterol but also decreased triglycerides and the Total to HDL ratio. This shows the added advantages of overall lipid level management using Cardiosmile rather than sterol esters.

5 REFERENCES American Diabetes Association (2008). Nutrition recommendations and interventions for diabetes. A position statement of the American Diabetes Association in Diabetes Care (pp ). Assmann, G., Schulte, H., von Eckardstein, A., & Huang, Y. (1996). High-density lipoprotein cholesterol as a predictor of coronary heart disease risk. The PROCAM experience and pathophysiological implications for reverse cholesterol transport. Atherosclerosis, 124(Suppl.), S11 S20. Berger, A., Jo es, P. J., & A u eis, S. S Pla t sterols: Fa tors affe ti g their effi a y a d safety as functional food ingredients. Lipids in Health and Disease, 3,5. Demonty, I., Ras, R. T., van der Knaap, H. C., Duchateau, G. S., Meijer, L., Zock, P. L., & Trautwein, E. A. (2009). Continuous dose-response relationship of the LDL-cholesterol-lowering effect of phytosterol intake. Journal of Nutrition, 139(2), Fornari, T., Torres, C. F., Torrelo, G., Senorans, F. J., & Reglero, G. (2009). Production of phytosterol esters from soybean oil deodorizer distillates. European Journal of Lipid Science and Technology, 111(5), Genest, J., McPherson, R., Frohlich, J., Anderson, T., Campbell, N., Carpentier, A., & Ur, E. (2009) Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult 2009 recommendations. Canadian Journal of Cardiology, 25(10), Health Canada (2010). Plant sterols and blood cholesterol lowering. Ottawa (ON): Health Canada, Food Directorate, Health Products and Food Branch (Bureauof Nutritional Sciences) Jones, P. J., Vanstone, C. A., Raeini-Sarjaz, M., & St-Onge, M. P. (2003). Phytosterols in low- and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels. Journal of Lipid Research, 44(9), NCEP (2001). Executive summary of the third report of the national cholesterol education program expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III). The Journal of the American Medical Association, 285(19), Ostlund, R. E., Jr., Spilburg, C. A., & Stenson, W. F. (1999). Sitostanol administered in lecithin micelles potently reduces cholesterol absorption in humans. American Journal of Clinical Nutrition, 70(5), Richelle, M., Enslen, M., Hager, C., Groux, M., Tavazzi, I., Godin, J. P., & Fay, L. B. (2004). Both free and esterified pla t sterols redu e holesterol a sorptio a d the ioa aila ility of eta arote e a d alphatocopherol in normocholesterolemic humans. American Journal of Clinical Nutrition, 80(1), WHO (2011). Cardiovascular diseases (CVDs) WHO Fact Sheet NO.317. Geneva, Switzerland: World Health Organization (W) DISCLAIMER: The information in this document is provided for informational purposes only. Nutrartis disclaims all warranties, express or limited, including, but not limited, to the implied warranties of merchantability and fitness for a particular purpose.