Clinically proven to quickly lower total cholesterol levels in the blood plus all the benefits of Omega-3

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1 Natural Health Product Clinically proven to quickly lower total cholesterol levels in the blood plus all the benefits of Omega-3

Also known as Coronary Artery Disease, it is a disease of the blood vessels supplying the heart muscle Disease of the blood vessels supplying the brain Disease of the blood vessels supplying the arms

2 CARDIOVASCULAR DISEASE Cardiovascular disease refers to a group of disorders that relate to the heart and blood vessels. These may include 1 : Coronary Heart Disease: Cerebrovascular Disease: Peripheral Arterial Disease: Rheumatic Heart Disease: Congenital Heart Disease: Deep Vein Thrombosis and Pulmonary Embolism: Also known as Coronary Artery Disease, it is a disease of the blood vessels supplying the heart muscle Disease of the blood vessels supplying the brain Disease of the blood vessels supplying the arms and legs Damage to the heart muscle and heart valves from rheumatic fever, caused by streptococcal bacteria Malformations of heart structure existing at birth Blood clots in the leg veins which can dislodge and move to the heart and lungs Heart attacks and strokes are usually acute events mainly caused by a build-up of fatty deposits on the inner walls of the blood vessels that prevent blood from flowing to the heart or brain 1. Source: WHO Global Status Report 2014 Other Noncommunicable diseases, 27% Malignant Neoplasm, 23% RISK FACTORS 3.4 Cardiovascular Disease, 37% Diabetes, 4% Respiratory Disease, 8% HEART DISEASE IN CANADA 2 2 nd leading cause of death among Canadians Men are 2x more likely to suffer from a heart attack than women Men are diagnosed with heart disease about 10 years younger than women About 1 in 12 adults (age 20+) live with diagnosed heart disease Unhealthy Diet Unhealthy Weight Stress Smoking Physical Inactivity Excessive Alcohol & Drug Abuse Hypertension Family History of Heart Disease 2

Abnormally high cholesterol levels (hypercholesterolemia) are strongly associated with cardiovascular disease because it promotes atheroma development in arteries.

3 Abnormally high cholesterol levels (hypercholesterolemia) are strongly associated with cardiovascular disease because it promotes atheroma development in arteries. Monitoring cholesterol for the management of abnormal levels and the prevention of cardiovascular disease is particularly important for males over 40 years of age, as well as menopausal females or females over 50 years. People with diabetes and atherosclerosis, or people who are prone to risk factors such as smoking, abdominal obesity, hypertension or a strong family history of premature cardiovascular disease can also benefit from lipid monitoring and management. 4 CHOLESTEROL Although cholesterol is essential for human health, high levels of cholesterol in the blood stream can lead to damaged blood vessels and cardiovascular disease. 39% of Canadians age 6 to 79 have an unhealthy level of total cholesterol; and unhealthy levels of bad cholesterol appeared to increase significantly with age 4. Low density lipoprotein (LDL) is the major cholesterol-carrying lipoprotein in plasma and is the causal agent in many forms of coronary heart disease 7 The risk of heart attacks is 3x higher in those with hypercholesterolemia, as compared to those who have normal blood lipid profiles. The WHO delineated that unhealthy diets, such as those high in fats, salt and free sugar and low in complex carbohydrates, fruits, and vegetables lead to increased risk of cardiovascular disease. 8 TYPES OF CHOLESTEROL 5 Total cholesterol is a measure of the total amount of cholesterol in your blood and is based on the High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and triglyceride numbers. LDL cholesterol (or Low Density Lipoprotein cholesterol) makes up the majority of the body s cholesterol. LDL is known as bad cholesterol because having high levels can lead to plaque buildup in your arteries and result in heart disease and stroke. HDL cholesterol (or High Density Lipoprotein cholesterol) absorbs cholesterol and carries it back to the liver to be excreted from the body. HDL is known as good cholesterol because having high levels can reduce the risk for heart disease and stroke. LOWERING YOUR CHOLESTEROL LEVELS 6 Eating healthy food can help lower your LDL cholesterol levels, and a healthy diet may help protect the body from the damaging effect of cholesterol. You can raise your HDL cholesterol levels by quitting smoking, losing weight and exercising. Following a healthy low-fat diet almost always lowers cholesterol levels. 3

4 Natural Health Product Probiotics are live micro-organisms which when administered in adequate amounts, confer a health benefit on the host 5. TERRACARDIO PLUS is a patented blend of lactic acid bacteria composed of Lactobacillus plantarum CECT 7527, 7528 and 7529 and linum usitatissimum (linseed oil). Lactobacillus plantarum is a gram positive aero tolerant bacterial organism commonly found in many fermented food products as well as anaerobic plant matter. It is a helpful probiotic that fiercely attacks pathogenic bad bacteria in the body. 7 Linum usitatissimum is a type of plant that yields oil which is rich in unsaturated fatty acids, especially alpha-linolenic acid (ALA). Consumption of the oil or seed has been reported to have beneficial effects on cardiovascular health. Flaxseed is an alternative to marine products and is one of the richest sources of the plant-based omega-3 fatty acid, ALA 11. MECHANISM OF ACTION TERRACARDIO PLUS reduces both the bioavailability of the dietary cholesterol and endogenous cholesterol by means of a dual mechanism of action: reduction of enterohepatic bile salt recirculation and direct metabolism of dietary cholesterol in the gut 6. Besides the main mechanisms of action that favor plasma cholesterol reduction, TERRACARDIO PLUS s strains have the ability to promote an anti inflammatory effect by modulating the immune system and production of Short Chain Fatty Acids. TERRACARDIO PLUS s strains favor a release of an anti inflammatory cytokine profile, as well as the synthesis of short chain fatty acids (propionic and butyric), which provide an anti inflammatory effect (propionic) or allow the correct nutritional state of colonocytes (butyric). Short-chain Fatty Acids Strain Butyric acid Propionic acid (mg/l) (mg/l) Lp CECT Lp CECT Lp CECT Lp 299v Strains in TERRACARDIO have demonstrated more than 95% survival during the course of the different physiological conditions found in the digestive tract, until arriving in the small intestine 5 The three strains in TERRACARDIO PLUS, especially CECT 7529 produced large quantities of propionic and butyric acids (as compared to a control Lp 299v) 4. A large quantity of propionic acid causes a decrease in the systemic levels of blood lipids by inhibiting hepatic cholesterol synthesis and/or redistributing cholesterol from plasma to the liver. Moreover, propionic acid has anti-inflammatory properties which may contribute to the inhibition of the early stage of artheorsclerosis 4 4

5 Source of ALA ALA Content (g) Pumpkin seeds (1 tbsp) Olive oil (1 tbsp) Walnuts, black (1 tbsp) Soybean oil (1 tbsp) Rapeseed oil (1 tbsp) Walnut oil (1 tbsp) Flaxseeds (1 tbsp) 2.35 Walnuts, English (1 tbsp) Flaxseed oil (1 tbsp) Almonds (100 g) 0.4 Peanuts (100 g) Beans, navy, sprouted (100 g) 0.3 Broccoli, raw (100 g) 0.1 Mustard (100 g) 0.1 Purslane (100 g) 0.4 Spinach (100 g) 0.1 Seaweed, spirulina, dried (100 g) 0.8 Beans, common, dry (100 g) 0.6 Chickpeas, dry (100 g) 0.1 Soybeans, dry (100 g) 1.6 Oats, germ (100 g) 1.4 Rice, bran (100 g) 0.2 Wheat, germ (100 g) 0.7 Avocados, California, raw (100 g) 0.1 Raspberries, raw (100 g) 0.1 Strawberries, raw (100 g) 0.1 Table 1: Selected sources of alphalinolenic acid (ALA) and content of ALA in selected novel sources of omega-3 polyunsaturated fatty acids 11. HOW CAN TERRACARDIO PLUS HELP? The three stains of L. plantarum found in TERRACARDIO PLUS were found to have high BSH activity. The close relationship existing between high bacterial BSH activity and the reduction of cholesterol renders the present strains useful as hypocholesterolemic agents CECT 7527, 7528 and 7529 also produce large quantities of short chain fatty acids (SCFAs), which yield further beneficial effects ALA modulates hepatic cholesterol metabolism, hence contributing to the maintenance of normal blood cholesterol levels. Works on both dietary and enterohepatic cholesterol. Reduces systemic inflammation markers which positively affect cardiovascular health 5

6 OMEGA-3 Omega-3 (n-3) fatty acids can be divided into 8 : 1) ALA (Alpha-Linolenic Acid) from plant origin 2) EPA (Eicosapentaenoic Acid) 3) DHA (Docosahexaenoic Acid) from seafood Because the human body lacks the enzymatic capacity to synthesize ALA, it is essential to obtain it from diet. To achieve an adequate ALA intake, food sources such as flaxseed and flaxseed oil, walnuts and walnut oil, and canola and soybean oil are recommended 8 Omega-3 fatty acids possess anti-inflammatory, anti-arrhythmic, and antithrombotic properties 10. Through an inefficient enzymatic process of desaturation (the rate of conversion is less than 1 percent), ALA produces EPA (20 carbons) and DHA (22 carbons), precursors to a group of eicosanoids (prostaglandins, thromboxanes, and leukotrienes) that are anti-inflammatory, antithrombotic, antiarrhythmic, and vasodilatory. The longer chain fatty acid derivative of linoleic acid is arachidonic acid (20 carbons), which is a precursor to a different group of eicosanoids that are pro-inflammatory and pro-thrombic. ALA and linoleic acid, use and compete for the same enzymes in the production of their longer chain fatty acids, EPA, and arachidonic acid. The ingestion of omega-3 fatty acid sources such as fish and fish oil provides EPA and DHA directly, therefore avoiding the competition for enzymes to convert ALA to EPA 10. Omega-3 fatty acids lower plasma triglyceride levels, particularly in persons with hypertriglyceridemia, by inhibiting the synthesis of very-low-density lipoprotein (VLDL) cholesterol and triglycerides in the liver 10. A review of human studies concluded that approximately 4 g per day of omega-3 fatty acids reduced serum triglyceride concentrations by 25 to 30 percent, increased serum low-density lipoprotein (LDL) cholesterol levels by 5 to 10 percent, and increased high density lipoprotein (HDL) cholesterol levels by 1 to 3 percent 10. Omega-3 fatty acids also appear to have a dose response hypotensive effect in patients with hypertension and have little to no effect in normotensive patients 10. It has been reported that reducing dietary intake of omega-6 fatty acids while increasing consumption of omega-3 fatty acids reduces the inflammatory mediators of rheumatoid arthritis and, consequently, allows some patients to reduce or discontinue use of nonsteroidal anti-inflammatory drugs 10 In general, flaxseed-enriched diets have been reported to induce anywhere from 0% to 18% decreases in LDL and 0% to 11% decreases in total cholesterol 12. 6

CHOLESTEROL SYNTHESIS & ENTEROHEPATIC CIRCULATION Enterohepatic circulation is a physiological process whereby bile salts used for the digestion and absorption of nutrients are re-absorbed and

7 CHOLESTEROL SYNTHESIS & ENTEROHEPATIC CIRCULATION Enterohepatic circulation is a physiological process whereby bile salts used for the digestion and absorption of nutrients are re-absorbed and transported back to the liver via the intestine. Up to 95% of bile salts are reabsorbed normally which limits the need for the liver to absorb cholesterol from the blood in order to synthesize new bile salts. Bacteria within the intestinal microflora perform enzymatic activities that reduce the reabsorption of bile salts. This causes the liver to compensate for the loss of bile salts reabsorbed by synthesizing new ones which is done by consuming cholesterol from the blood. The resulting effect is a reduction in blood cholesterol levels. There are two sources of plasmatic cholesterol in the body: diet and endogenous synthesis, through its own enterohepatic cholesterol cycle. Dietary cholesterol is not the main source of plasmatic cholesterol, but rather the endogenous enterohepatic cholesterol cycle that is responsible for 70% of cholesterol present in plasma through the intestinal absorption of bile salts. 1. The liver produces bile salts from cholesterol found in the blood 3. The bile salts are reabsorbed at the intestinal level to be released again when required. 2. The bile salts are released into the intestine to help digest fats and cholesterol Hydrolyzes bile salts into bile acids in the intestine, thereby preventing reabsorption. The liver requires blood cholesterol in order to produce new bile salts, decreasing the concentration of cholesterol in the blood. Omega-3 fatty acids decrease production of triglycerides in the liver by a direct effect on its metabolism and consequently decrease VLDL production. 7

Total Cholesterol Levels (mmol/l) LDL Cholesterol Levels (mmol/l) Cholesterol Level (mmol/l) CLINICAL TRIALS Zhao et al (2004) conducted a randomized, controlled, cross over study, to observe the

6 5 4 3 2 1 0 The Effect of the Average American Diet vs an ALA Diet on Cholesterol Levels Baseline Total Cholesterol (TC) LDL Cholesterol Average American Diet ALA Diet HDL Cholesterol Total

4 mmol/l after 6 weeks on a diet rich in ALA compared to the Average American Diet Goyens et al (2006) conducted a randomized, double-blind nutritional intervention study to compare the effects of

8 Total Cholesterol Levels (mmol/l) LDL Cholesterol Levels (mmol/l) Cholesterol Level (mmol/l) CLINICAL TRIALS Zhao et al (2004) conducted a randomized, controlled, cross over study, to observe the effects of ALA on multiple cardiovascular risk factors by evaluating 23 subjects for 6 weeks The Effect of the Average American Diet vs an ALA Diet on Cholesterol Levels Baseline Total Cholesterol (TC) LDL Cholesterol Average American Diet ALA Diet HDL Cholesterol Total Cholesterol (TC) LDL Cholesterol HDL Cholesterol Baseline AA Diet ALA Diet Total cholesterol (TC) decreased by 0.6mmol/L and LDL Cholesterol by 0.4 mmol/l after 6 weeks on a diet rich in ALA compared to the Average American Diet Goyens et al (2006) conducted a randomized, double-blind nutritional intervention study to compare the effects of ALA to those of EPA plus DHA on cardiovascular risk markers in healthy elderly subjects. Effect of ALA vs EPA and DHA on Average Total Cholesterol Levels Baseline ALA After 6 weeks EPA & DHA Effect of ALA vs EPA and DHA on Average LDL Cholesterol Levels Baseline After 6 weeks ALA EPA & DHA A total of 37 subjects were randomly assigned to either the control group (n=10), the ALA-rich diet (n=13; 6.8g/day) or the EPA/DHA-rich diet (n=14; 1.05g EPA/day g DHA /day) It was concluded that in healthy, elderly subjects, ALA might affect concentrations of LDLcholesterol more favourable than EPA/DHA. 8

CLINICAL TRIALS Harper et al, (2006) conducted a randomized, double blind trial involving 56 participants to study the effect of daily supplementation with 3g of ALA on the plasma concentration of

9 CLINICAL TRIALS Harper et al, (2006) conducted a randomized, double blind trial involving 56 participants to study the effect of daily supplementation with 3g of ALA on the plasma concentration of long-chain (n-3) fatty acids. 31 participants were given 3g ALA/day from flaxseed oil capsules and 25 participants were given olive oil placebo capsules (5.2g/day) Flaxseed Oil (3g/day) Olive Oil (5.2g/day) Baseline Week 12 Baseline Week 12 ALA (µmol/l) EPA (µmol/l) DPA (µmol/l) DHA (µmol/l) Plasma Concentrations (µmol/l) at 12 Weeks ALA (µmol/l) EPA (µmol/l) DPA (µmol/l) DHA (µmol/l) Flaxseed Olive Oil Plasma EPA Levels and DPA levels increased significantly from baseline values (60% and 25%) respectively. ALA is a major dietary (n-3) fatty acid which is converted to longer-chain (n-3) PUFA, such as eicosapentaenoic acid (EPA) and possibly docosahexaenoic acid (DHA). EPA and DHA are fish-based (n-3) fatty acids that have proven cardio-protective properties. 9

10 SUPPLEMENT INFORMATION Supplement Information One box of TERRACARDIO PLUS contains 30 capsules and 30 soft gels. Recommended Use: Source of probiotics. Source of omega-3 fatty acids for the maintenance of good health. Medicinal Ingredients (per capsule): Lactobacillus plantarum.1.2 billion CFU Linum usitatissimum mg Directions for use: Adults: Take one capsule and one soft gel daily. Caution: This product is intended for adults 18 years of age or older. Pregnant and breastfeeding women are advised to consult with their healthcare practitioner prior to using this product. Storage: Store at room temperature. TERRACARDIO PLUS has been registered with Health Canada; the Health Canada NPN number is: Safety & Drug Interactions: Keep out of reach of children. If you are on antibiotics, take at least 2-3 hours before or after your antibiotics. If you have fever, vomiting, bloody diarrhea or severe abdominal pain, consult a health care practitioner prior to use. If symptoms of digestive upset (e.g. diarrhea) occur, worsen, or persist beyond 3 days, discontinue use and consult a healthcare practitioner. If you have an immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment), do not use this product. Food supplements should not be used as a substitute for a varied balanced diet and healthy lifestyle. Keep in a fresh dry place. 10

11 FAQs 1. How should TERRACARDIO PLUS be taken? One capsule and one soft gel is to be taken daily. TERRACARDIO PLUS can be taken with or without food and is recommended for individuals 18 years of age or older. 2. Who should take TERRACARDIO PLUS? Individuals who are looking for a safe and natural way to lower their cholesterol, increase their Omega-3 intake or maintain a good cardiovascular health status 3. Are there any known side effects of taking TERRACARDIO PLUS? No, TERRACARDIO PLUS exerts no side effects on the individual. 4. Has TERRACARDIO PLUS been clinically tested? Yes, there are several trials that evaluated the efficacy of TERRACARDIO PLUS. 5. What benefits can my patient expect from TERRACARDIO PLUS? The components in TERRACARDIO PLUS (especially linum usitatissimum, commonly known as linseed or flaxseed oil) modulates hepatic cholesterol metabolism, contributing to the maintenance of normal blood cholesterol levels. TERRACARDIO PLUS works on both dietary and endogenous cholesterol, as well as reduces systemic inflammation markers which positively affects cardiovascular health. 6. Where is TERRACARDIO PLUS available? TERRACARDIO PLUS is available in stores and online at or by calling , customerservice@xediton.com CONTACT US For more information, please visit or call XEDITON PHARMACEUTICALS INC 2000 Argentia Road Mississauga, ON L5N 1W1 customerservice@xediton.com REFERENCES 1 Canada, P. H. (2017, February 10). Heart Disease in Canada. 2 WHO Fact Sheet 2016: Cardiovascular Diseases 3 Cholesterol-What you can do to lower your level 4 Bosch, M. et al. (2014). Lactobacillus plantarum CECT 7527, 7528 and 7529: probiotic candidates to reduce cholesterol levels. Journal of the Science of Food and Agriculture, 94(4), Fuentes, M. C. et al. (2013). Cholesterol-lowering efficacy of Lactobacillus plantarum CECT 7527, 7528 and 7529 in hypercholesterolaemic adults. British Journal of Nutrition, 109(10), Nabel, E. G. (2003). Cardiovascular disease. New England Journal of Medicine, 349(1), Mani, V. et al. (2012). Hypocholesterolaemic Effects of Probiotics. COMPLEMENTARY THERAPIES FOR THE CONTEMPORARY HEALTHCARE, Geleijnse, J. M. et al. (2010). Alpha-linolenic acid: is it essential to cardiovascular health?. Current atherosclerosis reports, 12(6), Covington, M. B. (2004). Omega-3 fatty acids. Atlantic, 1(2.0). 10 Zhao, G. et al. (2004). Dietary α- linolenic acid reduces inflammatory and lipid cardiovascular risk factors in hypercholesterolemic men and women. The Journal of Nutrition, 134(11), Rodriguez- Leyva, D. et al. (2010). The cardiovascular effects of flaxseed and its omega-3 fatty acid, alpha-linolenic acid. Canadian Journal of Cardiology, 26(9), Goyens, P. L. L., & Mensink, R. P. (2006). Effects of alpha-linolenic acid versus those of EPA/DHA on cardiovascular risk markers in healthy elderly subjects. European journal of clinical nutrition, 60(8), Harper, C. R. et al (2006). Flaxseed oil increases the plasma concentrations of cardioprotective (n-3) fatty acids in humans. The Journal of nutrition, 136(1),

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Clinically proven to quickly relieve symptoms of common gastrointestinal disorders. TERRAGASTRO - Good health starts in the gut

Clinically proven to quickly relieve symptoms of common gastrointestinal disorders GASTROINTESTINAL DISEASE Referred to as gastrointestinal diseases, they are common disorders which affect the esophagus,