25. Juli 2016
Research #17 Hanf-basierte Tiernahrung
Unternehmensdetails True Leaf Medicine International Ltd. 100 Kalamalka Lake Road, Unit 32 Vernon, British Columbia V1T 9G1, Kanada Telefon: +1 778-389-9933 Email:
[email protected] www.trueleaf.com Aktien im Markt: 52.800.371
True Leaf hat gerade erst begonnen Wurzeln zu schlagen (um danach gross zu wachsen) Heute verschickte der Vorstandsvorsitzende von True Leaf Medicine International Ltd., Michael Harcourt, einen Brief an alle Interessengruppen, um die bemerkenswerte Unternehmenserfolge der letzten 12 Monate hervorzuheben. Seitdem True Leaf im Februar 2015 an die Börse ging, fungiert Harcourt als Vorstandsvorsitzender, zuvor war er Bürgermeister von Vancouver und Ministerpräsident von British Columbia. Nach erfolgreichen Markteinführungen in Kanada, USA und Europa kommen die hanfbasierten Hunde-Kausnacks sehr gut im Markt an. Chris Parry zollte bereits im Mai gehörig Respekt und auch Rockstone glaubt stark daran, dass das Unternehmen auf einem guten Weg ist, ein ernstzunehmender Mitbewerber in der Tierfutterbranche in Nord-Amerika und Europa, möglicherweise auch bald in Asien, zu werden. Das Unternehmen macht den Eindruck, einen grossen Vorsprung zu anderen Wettbewerbern zu haben, da ihre Produkte in den Märkten bereits Wurzeln schlagen, wo True Leaf der Pionier in einem riesigen potentiellen Markt ist. Ohne zu vergessen, dass das Unternehmen erst vor kurzem damit begonnen hat, ihre Produkte zu verkaufen, sollten Leser keine grossen Umsätze erwarten, die anfangs berichtet werden. Die Verkäufe dürften signifikant ansteigen, wenn die Laden-Penetration innerhalb ihrer Distributionsreichweite ansteigt und Erweiterungen der Produktlinie ihre Auftragsbücher anwachsen lassen.
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Kanada (CSE)
Kanada-Symbol: MJ Aktueller Kurs: $0,26 CAD (22.07.2016) Marktkapitalisierung: $14 Mio. CAD
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Deutschland (XETRA)
Deutschland Symbol / WKN: TLA / A14NM1 Aktueller Kurs: €0,20 EUR (22.07.2016) Marktkapitalisierung: €11 Mio. EUR
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Research #17 | True Leaf Medicine International Ltd.
Tr u e L e a f U n t e r n e h m e n s u p d a t e : Brief vom Vorstandsvorsitzenden an Interessengruppen
21. Juli 2016 Sehr geehrte Aktionäre & Interessengruppen, ich möchte diese Gelegenheit nutzen, um Sie über die bemerkenswerte Transformation des Unternehmens in den vergangenen 12 Monaten zu informieren. Wie Sie wissen, hat das Unternehmen 2013 bei Health Canada einen Antrag auf Lizenzierung als kanadischer Marihuanaproduzent im Rahmen der Marihuana for Medicinal Purposes Regulations (MMPR) gestellt. Dieser Antrag hat die erste und zweite Stufe des Selektionsverfahrens von Health Canada erfolgreich durchlaufen und wir warten nun auf die Erteilung einer sog. „Pre-License Inspection“-Genehmigung. Während dieser Prozess im Hintergrund läuft, konzentrieren wir uns auf die Entwicklung unserer langfristigen Strategie: die Markteinführung von Produkten, die zur Förderung einer gesunden Lebensweise von Menschen und ihren Haustieren beitragen. 2015 und 2016 haben wir die Entwicklung unserer Marke True Leaf Pet konsequent vorangetrieben. Dies stellt eine natürliche Ergänzung zu unserem MMPR-Antrag dar und wir können hierbei auf das Wissen, die Kontakte und die Erfahrung unseres CEO Darcy Bomford zurückgreifen, der vor der Gründung von True Leaf 25 Jahre lang in der Tierfutterindustrie tätig war. Unter Darcys Leitung hat True Leaf Pet mit einem Sortiment an Kausnacks und Nahrungsergänzungsmitteln auf Hanfbasis den Einstieg in die globale 104,9-Milliarden-Dollar-Heimtierbranche gemeistert. Dieses Sortiment wird in Kanada, den USA und in Europa über Vertriebskanäle für Naturheilkunde und Tiermedizin vertrieben. Die funktionellen True Hemp-Kausnacks für Hunde stehen in Einklang mit dem Auftrag von True Leaf, der darin besteht, Menschen und ihren Haustieren durch Rezepturen auf Hanfbasis eine höhere Lebensqualität zu bieten. In allen drei Rezep-
turen der True Hemp-Kausnacks für Hunde wird die Bedeutung von Hanf als primärer Wirkstoff hervorgehoben. Hanf unterstützt den Körper in seiner natürlichen Reaktion auf Entzündungen und fördert die kognitive Gesundheit sowie die Gesundheit von Haut und Fell. Hanf ist eine Quelle von Omega-Fettsäuren, Gamma-Linolensäure und anderen Stoffen, die für ihre allgemeine gesundheitsfördernde Wirkung in Menschen und Tieren bekannt sind. Unsere Strategie zielt darauf ab, Produkte auf den Markt zu bringen, die nach Zulassung durch die zuständigen Behörden erfolgreich auf dem Weltmarkt abgesetzt werden können. Das Sortiment an Hanfprodukten von True Leaf wird diesen Zielen gerecht und es freut mich, zu berichten, dass wir eine Reihe wichtiger Meilensteine erreicht haben. • November 2015: Produkteinführung in Kanada • Januar 2016: Eröffnung des Onlineshops in Kanada • März 2016: Produkteinführung in den USA • März 2016: Einrichtung eines Distributionszentrums in den USA • Mai 2016: europäische Produkteinführung auf der Interzoo® • Juni 2016: Eröffnung des Onlineshops in den USA • Juli 2016: Gründung der europäischen Tochter True Leaf Pet Europe LLC • August 2016: Beginn der Produktion in Europa Bemerkenswert hierbei ist, dass dieser Plan in weniger als einem Jahr umgesetzt werden konnte. Gleichzeitig laufen eine Anzahl an Initiativen, bei denen weitere Entwicklungen zu erwarten sind: • Ausbau des Vertriebs im europäischen Markt • Erweiterung des Hanfproduktsortiments in den drei bestehenden Märkten von True Leaf Pet • Prüfung der Realisierbarkeit eines Direktverkaufs von Tiernahrung auf Hanfbasis in Kanada und Europa
• Analyse zukünftiger Marktmöglichkeiten im Asien-Pazifik-Raum Die True Hemp-Produkte von True Leaf Pet begeistern Lieferanten und Verbraucher gleichmaßen, egal, wo das Team von True Leaf diese vorstellt. Die Märkte signalisieren ebenfalls eine Akzeptanz unserer Strategie und Produkte. In den vergangenen zweieinhalb Monaten stieg unsere Marktkapitalisierung um mehr als 5 Millionen C$, nachdem sich unser Aktienpreis mehr als verdoppelte. So konnte das Unternehmen seinen Barbestand um mehr als 750.000 C$ aufstocken und Schulden in Höhe von 300.000 C$ in Aktien umwandeln, womit unsere Bilanz deutlich gestärkt wurde. Mit der weiteren Entwicklung unserer strategischen Ausrichtung könnten in Zukunft weitere Finanzierungen durchgeführt werden. Wir haben ein starkes Fundament gelegt und konzentrieren uns nun verstärkt auf die Vermarktung der True Hemp-Produkte. Wir werden alle drei Monate über den aktuellen Stand unserer Marketing- und Vertriebsaktivitäten informieren. Wir sehen einer anhaltend erfolgreichen Zukunft entgegen. Weiterhin mit dem Ziel vor Augen, medizinisches Marihuana herzustellen und zu vertreiben, sind wir zuversichtlich, den Unternehmenswert für Investoren steigern zu können, während wir zugleich nutzbringende Produkte für Menschen und ihre Haustiere zur Verbesserung ihrer Lebensqualität anbieten. Hochachtungsvoll, Michael Harcourt, Chairman True Leaf Medicine International Ltd.
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Research #17 | True Leaf Medicine International Ltd.
INFOGRAPHIC: Functional dog, cat food and pet treat trends Consumers’ purchases reflect a concern for their pets’ health By Tim Wall for PetFoodIndustry.com on July 18, 2016; Infographic by Jennifer Keller, WATT Global Media As pet food becomes increasingly specialized, with manufacturers catering to consumers’ desires to meet the individual needs of their pets, functional ingredients are becoming more of a trend than ever. High omega-3 pet food formulas, for example, are purchased by 14 percent of dog owners and 10 percent of cat owners in the US, according to a March 2016 Packaged Facts report, Pet food in the US. Roughly 11 percent of dog owners and 8 percent of cat owners purchase foods with high antioxidant claims, while 7 percent of dog owners and 6 percent of cat owners look for foods with probiotics/prebiotics.
What are functional ingredients? Functional ingredients in pet foods are marketed as having special nutritional benefits in terms of general wellness or address specific health concerns such as digestion, joint and cartilage function, immune system strength or dental health. In a sense, all pet food is functional. For years there have been specialized pet food formulations by life stage, breed size and activity level, weight control, specific ingredient avoidance and other issues. These functional pet food types echo the targeted marketing of functional foods for humans. Fueling this trend is America’s increasing attention to health issues, both human and pet, which ties in to an aging and often overweight population, again both human and pet. “The same health-conscious Boomers and Millennials are driving the need for new innovative nutritional solutions for their beloved companion animals,” Juan Gomez-Basauri, PhD, global director for companion animal nutrition with Alltech, told Petfood Industry. “As pet parents age, so do their pets, and we then see
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Research #17 | True Leaf Medicine International Ltd.
the same functional ingredients, like probiotics (Lactobacillus bacteria), prebiotic fibers (beta-glucans, manna oligosaccharides), nucleotides and omega-3 fatty acids (algae-sourced), applied to pet foods.”
Companies are individualizing their efforts, playing to their strengths and choosing ingredients that will best contribute to a complex market.
Industry opportunities
New functional ingredient concepts come in two different ways:
With such a wide range of options for catering to the need for functional ingredients in pet foods, how is the industry taking advantage of such an opportunity?
1) through ideas on how to improve our pets’ health, and 2) from novel ingredients introduced through suppliers and manufacturers.
The first way causes nutritionists to search constantly through the market and researchers to find novel ingredients that could achieve the target goals. This requires time and huge networking in order to find the proper solution. The second one is to be constantly in contact with ingredients suppliers and manufacturers and let them know that you are always open to novelties.
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Research #17 | True Leaf Medicine International Ltd.
Research Übersicht Research #16 “Neuer Vertriebskanal: True Leaf Produkte werden jetzt auch online verkauft“ Research #15 “Hanf für Hunde: True Leaf aus Kanada bringt besonderen Leckerbissen zur Interzoo Leitmesse für die internationale Heimtierbranche“ Research #14 “True Leaf gibt Gas und bringt True Hemp nach Europa“ Research #13 “True Leaf erobert den US-Tierfuttermarkt“ Research #12 “True Leaf verkauft Hanfprodukte in 3500 US-Geschäften“ Research #11 “True Leaf Produkte nun in 47 Geschäften in Kanada erhältlich“ Research #10 “True Leaf verkauft schnell“ Research #9 “True Leaf expandiert nach Europa“ Research #8 “True Leaf enthüllt neue Produktlinie“ Research #7 “Ein wichtiges Puzzle-Stück für den sich anbahnenden Erfolg von True Leaf“ Research #6 “True Leaf hat den kanadischen Vertrieb für eigene Hanf-Produktlinie sichergestellt“ Research #5 “CEO-Interview mit Darcy Bomford“
Analysten-Profil und Kontakt: Stephan Bogner (Dipl. Kfm. FH) Analyst Rockstone Research 8050 Zürich, Schweiz +41-44-5862323
[email protected] Für weitere Informationen und kostenlosen Newsletter besuchen Sie www.rockstone-research.com Stephan Bogner studierte an der International School of Management (Dortmund), European Business School (London) und University of Queensland (Brisbane, Australien).
Unter Prof. Dr. Hans J. Bocker schloss Bogner 2002 seine Diplomarbeit über den Goldmarkt ab. Ein Jahr später übersetzte er das Buch von Ferdinand Lips („Gold Wars“) ins Deutsche. Nach 5 Jahren Aufenthalt in Dubai lebt Bogner mittlerweile in Zürich und ist der Geschäftsführer der Elementum International AG, welche Firma auf die zoll- und MwSt.-freie Einlagerung von physischem Gold und Silber in einem Hochsicherheitslager innerhalb des St. Gotthard Gebirgsmassivs in der Zentralschweiz spezialisiert ist.
Research #4 “True Leaf auf bestem Weg zum lizenzierten Marijuana-Produzenten in Kanada“ Research #3 “True Leaf Medicine will in Produktion gehen“ Research #2 “True Leaf will im Herbst 2015 den Markt für Tiernahrung mit Hanf bereichern“ Research #1 “True Leaf geht an die Börse“
www.trueleaf.com
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Research #17 | True Leaf Medicine International Ltd.
Introducing: True Hemp™ HIP+JOINT, HEALTH and CALMING formulations In Rockstone‘s last report, trends in the pet foods industry have been presented along with an introduction to hemp (see report here). In this issue, details on the formulations of the True Hemp line are presented: True Leaf Pet’s new product line, True HempTM, uses hempseed powder in combination with other ingredients that complement the studied benefits of hempseed. The goal is that the additional ingredients in the treats help to emphasize the intrinsic qualities provided by the hempseed. True HempTM HIP & JOINT offers anti-inflammatory joint support; True HempTM HEALTH boosts general health and well-being, and True HempTM CALMING is for anti-anxiety and calming effects.
True Hemp HIP+JOINT Support (True Spirit™ Formula) Degenerative joint disease (DJD) or osteoarthritis (OA) is one of the most common chronic musculoskeletal diseases and causes of lameness in dogs47,48. Osteoarthritis is a painful, inflammatory disease of the joints, which is characterized by cartilage degeneration, boney hypertrophy at joint margins, and synovial membrane changes49-51. Dogs are usually stoic animals, and can hide the signs of OA until the disease has progressed significantly. Conventional treatment of OA has relied on drugs that control pain and inflammation, like non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs treat symptomatically, and can be associated with numerous side effects such as irritation of the gastrointestinal tract, renal toxicosis, and hepatic disease (especially in Labradors)52,53. Dogs are often used as research models for osteoarthritis in humans, so comparisons for treatment options are often made. It has been reported that 60–90% of dissatisfied human arthritis patients sought complementary therapies for their disease due to the side-effects associated with NSAIDs54. For these reasons, alternative and adjunctive therapies for the treat-
ment and management of OA in dogs are desirable. A nutraceutical that may be of benefit as an alternative approach for OA multimodal therapy is a product based on Perna canaliculs, or the green-lipped mussel (GLM). Analysis has shown GLM powder to be a rich source of nutrients including glycosaminoglycans such as chondroitin sulfates, amino acid (glutamine), omega-3 fatty acids including DHA and EPA, eicosatetraenoic acid, vitamins E and C, and minerals (zinc, copper, manganese)55,56. A 2007 study demonstrated proof of absorption of the omega-3 fatty acids after administration of GLM56. While it is not totally clear how GLM functions in the body57, many mechanisms have been proposed. In vivo studies have demonstrated anti-inflammatory effects, and GLM extracted lipids have been shown to possess significant cyclooxygenase (COX) and lipoxygenase (LOX-5) inhibitory activity58. This indicates that GLM seems to be working on the same mechanisms as newer NSAIDs58. Additionally, GLM may have immune system regulatory function, and promote humoral and cellular activity59. The chondroitin sulfate and the other glycosaminoglycans provided by GLM are building blocks of cartilage anabolism. They as-
sist in joint capsule water retention and help in adaptation to pressure changes; thereby absorbing shock induced by abnormal joint stress60. Multiple studies have been conducted on GLM’s efficacy and safety in humans and animals. GLM is documented to be efficacious in treating experimental arthritis in rats58,61, arthritis in humans62-65, chronic lameness in horses66, and arthritis in dogs56,67-69. A 2013 study56, provides strong clinical evidence to support feeding dogs with OA a GLM based diet. The weight bearing ability significantly increased over the 60 day period that GLM was introduced into a standardized controlled diet56. A double control and double blinded clinical trial in dogs69 used a dose of 2049 mg/kg/day depending on dog body weight for the first 10 days (loading dose), then half of the loading dose (10-25 mg/kg/day) for the rest of the 8 weeks. Dogs were also evaluated at 12 weeks. Dogs improved in the GLM group when compared to the placebo, although as expected, Carprofen (an NSAID) was a more effective treatment. This study, along with another, observed that beneficial effects of GLM treatment could last for 2-3 weeks after cessation of therapy if given for at least two months69,70. True Spirit contains comparable amounts of
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GLM with a loading dosage of approximately 26-66 mg/kg over 10 days, and a maintenance dose of approximately 1333 mg/kg depending on body weight. Additionally, GLM is reported to have no potential severe side effects in humans62-65, and in dogs56,68,69. In rats, GLM has been shown to have favorable GI tolerability and unaltered platelet aggregation at a high dose of 300 mg/kg57,58. Studies in humans have shown that a high dose of 3000 mg/day not only did not significantly alter gut microbiota, but also significantly improved gastrointestinal symptoms in OA patients64,65. Research also suggests that GLM may have chondroprotective properties due to its glycosaminoglycans, especially chondroitin sulfate, content72-74. An additional nutraceutical alternative to NSAIDs is curcumin, a polyphenolic compound commonly found in the household spice turmeric75,76. Curcumin has been found to be a potent anti-inflammatory, antioxidant, antiseptic, and anticancer agent77-79. Additionally it has been shown to have therapeutic potential in various chronic illnesses where inflammation is known to play a major role80. Curcumin has similar effects to NSAIDs in suppressing the production and catabolic action of pro-inflammatory cytokines that are known to play a key role in the pathogenesis of OA81. In vitro studies have shown curcumin to be an effective scavenger of reactive oxygen species (ROS) and reactive nitrogen species82,83. This is of importance, because the degradation of cartilage results from the combination of mechanical stress and increases of ROS and metalloproteinases84. Additional studies on mares affected by OA and osteochondritis have confirmed that curcumin possesses anti-inflammatory activity through the suppression of pro-inflammatory cytokines and catabolic enzymes85. Two studies86,87 have examined a twicedaily dose of 4 mg/kg curcuminoids and curcumin phytosome, respectively, for the treatment of osteoarthritis in dogs, and it had minimal adverse effects. The 2003 study, an 8 week trial, showed a statistically significant treatment effect in favor of turmeric extract at this dose86. The 2012 study, a 20-day study, observed that curcumin phytosome (CurcuVET®) regulated molecular targets of inflammatory response, including targets additional to those seen with NSAIDs. This study concluded that cur-
Research #17 | True Leaf Medicine International Ltd.
cumin can offer good complementary support for OA treatment, but studies on larger populations are needed for definitive conclusions87. At this time, studies to determine an effective daily supplemental dose of curcumin in dogs have not been completed. True Spirit contains 35 mg of turmeric root extract, with a dosing range of 3-9 mg/kg per dose depending on body weight. It is suggested to give the maintenance dose twice a day for 10 days (loading dose), and then resume with the maintenance dose once a day. Although turmeric extract has been shown to be safe even at very high dosage levels (e.g. 8g/day) in humans88; we believe that a lower long-term dose is appropriate given the lack of long term studies on turmeric supplementation in dogs. True Spirit’s dosing range is comparable to the previously examined doses. Other nutraceuticals, like the previously mentioned CurcuVET®, contains 50 mg of Curcumin Phytosome, equating to a range of 4 – 12 mg/kg daily89. In addition to hempseed meal, the True Spirit product line contains GLM and turmeric extract at doses researched as both safe and therapeutic. Currently, there are no studies on the effects of hempseed, GLM, and turmeric together. The goal of this combination is to promote analgesia, anti-inflammation, and chondroprotection for OA patients.
True Hemp HEALTH Support (True Love™ Formula) With advancements in veterinary medicine, the health and welfare of companion animals is continuously improving, and therefore the longevity of animals is increasing. Aging dogs are common population seen by clinicians. A 2012 email survey revealed that 33.2% of dogs were 6 to 10 years old, and 14.7% were older than 11 years; when compared to previous data, this represented an increase of 9.1% in the number of dogs older than 6 years in the United States90. What defines when a dog transitions into a senior or geriatric dog is highly variable and subjective91. For one example, the Senior Care Guidelines Task Force of the American Animal Hospital Association considers dogs to be seniors when they are in the last 25% of their predicted life span based on species and breed92. Whether or not a dog matches
the arbitrary guidelines of being a “senior,” it is important to assess in adult dogs both normal age-related change and age-related diseases. Common age-related diseases include but are not limited to cognitive dysfunction, chronic kidney disease, cancer, osteoarthritis, periodontal disease, and heart disease93-98. The incidence of disease in the aging dog population likely represents a continuum from normal to normal aging changes to disease caused by aging changes91. It is important to note, however, that different organ systems likely progress along the continuum at different rates depending on the individual animal91. Both normal age-related changes and age-related diseases are potentially amenable with nutritional intervention. It is important to consider that some interventions may be contraindicated in some conditions, so an individualized and commonly multimodal approach versus a universal approach is recommended91. Aging dogs have the potential to acquire dysfunctions in more than one organ system. As mentioned previously, long chain omega-3 PUFAs, like EPA and DHA, can have beneficial health effects for our aging patients; these include cardio-protection99-101, roles in neurological development and cognition preservation102-107, as well as modulation of the inflammatory response108-110. As inflammation provides the basis for many chronic health disorders, the physiologic functions of omega-3 PUFAs and their mechanisms in reducing inflammation are currently believed to be essential for organ health and function111. Omega-3 fatty acids have been observed to benefit a variety of disease processes including hypertension112, renal diseases113,114, arthritis115-117, skin disease118-121, gastrointestinal diseases122,123, and even cancer124. Omega-3 fatty acids, especially DHA, ha-
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ve been researched for years for their roles in cancer prevention and as an adjunctive therapy. Experimental cancer models indicate omega-3 PUFAs, especially EPA and DHA, may be preventative in the development of carcinogen-induced tumors, the growth of solid tumors, and the occurrence of cachexia and metastatic disease125-129. DHA appears to influence the growth of many types of cancer including both breast and prostatic cancer130-133. Elevated omega-3 fatty acids, especially DHA, have also been found to be associated with higher metastasis-free survival in breast cancer134. Current data is lacking on DHA‘s role in decreasing cancer risk in dogs, but there is current research on the use and benefit of DHA as an adjunctive therapy in dogs already diagnosed with cancer. For example, a 2000 study135 showed a direct correlation between DHA blood levels and improved disease-free interval for dogs with lymphoma treated with doxorubicin chemotherapy and a diet supplemented with n-3 fatty acids in the form of fish oils. This study also showed no clinically significant toxicities with DHA supplementation other than transient gastrointestinal distress linked to dietary change135. Therefore, there may be a benefit of doubling the dosage of the True Love™ formula to patients that have already been diagnosed with cancer, to give a larger dosage of DHA. This however, should only be done under guidance of a veterinarian. While hempseed products can provide a source of the ALA, SDA and GLA, True Love contains additional algae-sourced DHA, a long chain omega-3 fatty acid. The daily dose of DHA is variable depending on how much is provided in the base diet. True Love contains an average of 10 mg/kg dose of algae-based DHA (ranges from 6.5-16.5 mg/kg based on weight). Algae-based DHA is better than DHA derived from fish oil due to the potential of heavy metal and organophosphate contamination. The dose of DHA in True Love is comparable to other well-known omega-3 supplements including Welactin (11 mg/kg/day) and Omega Tri-V Capsules (6-13 mg/kg/day depending on bodyweight)136,137. Oxidative stress results from a disturbance in the balance between oxidant forces and antioxidant defenses in favor of the oxidants138. Oxidants are formed
Research #17 | True Leaf Medicine International Ltd.
as a normal product of aerobic metabolism, and in health, animals are equipped to deal with that level of oxidative stress. In pathophysiological conditions, however, oxidants, like reactive oxygen species (ROS), can be produced at elevated rates causing damage to crucial cellular components, such as proteins, lipids, lipoproteins and deoxyribonucleic acid (DNA)138,139. Aging has been shown to inconsistently affect antioxidant status, with decreases, no change, or increases in specific antioxidant compounds140,141. Oxidative damage that accumulates with age is thought to play a significant role in the development and progression of a number of diseases, such as cancers, cardiovascular diseases, osteoporosis, and other degenerative diseases like cognitive dysfunction139,142,143. The use of exogenous antioxidants is intended to boost depleted endogenous defense, assist in removing oxidants, and to ultimately help the body to return to an oxidative equilibrium. Studies on oxidative stress and antioxidants specific to dogs show possible areas for intervention. Viviano et al. found that clinically ill dogs had decreased red blood cell glutathione concentrations; glutathione being the major intracellular antioxidant in all mammalian cells that functions to maintain the cellular redox state144,145. Studies in oncology have seen altered levels of antioxidants in dogs with mast cell tumors, and changes in antioxidant capacity with oxidative stress and significant increases in ROS in dogs with lymphoma146-148. Kapun et al. found oxidative
stress with increased lipid peroxidation in dogs with atopic dermatitis149. In addition, the brain demonstrates the oxidative nature of aging well. In dogs, brain aging is complex, with both similarities and differences when compared to humans91. There are three main reasons why oxidative changes are particularly detrimental in the brain. The first is its high metabolic rate resulting in the production of reactive oxygen species, particularly in older individuals150. The second is its high lipid content, which increases its susceptibility to oxidative damage, and the third is its limited regenerative capacity, making damage more apparent91,151,152. In one study, a combination of environmental enrichment and antioxidants improved clinical signs related to cognitive dysfunction in dogs153. In another study, dogs fed a diet enriched in antioxidants showed improved learning, recognition and agility compared to those on a control diet152. Polyphenols are common constituents of plant origin foods, like fruit, and are a major source of dietary antioxidants154. The phenolic groups in polyphenols act on free radicals by accepting an electron to form relatively stable phenoxyl radicals; this disrupts the chain oxidation reactions in cellular components154. The True Love™ formula contains pomegranate seed extract (PSE), which contains polyphenolic compounds called tannins. There are minimal current studies on PSE and its clinical use in dogs; however, PSE has been studied to have antioxidant and cytoprotective activities on human cells as well as canine endo-
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Research #17 | True Leaf Medicine International Ltd.
thelial cells155-157. Additionally, pomegranate seed extract has been shown to have protective effects in both chemotherapeutic induced hepatotoxicity in rabbits and rats and nephrotoxicity in rats158,159 True Love™ contains PSE for its antioxidant effects and potential benefit for the aging canine. Aging dogs can acquire a multitude of health issues, including but not limited to cancer, cognitive dysfunction, heart disease, renal disease, gastrointestinal disease, and skin disease. While there can be breed specificities for certain conditions, no one dog is immune. In addition to hempseed meal, the True Love product line contains polyphenols and algae-based DHA. Currently, there are no studies on the effects of hempseed, polyphenols, and DHA together. The goal of this combination is to be used as a part of multimodal therapy on an individualized basis for the promotion of general health and antioxidant support for aging dogs.
True Hemp CALMING Support (True Calm™ Formula) Behavior problems are common amongst small animals. Recognition, intervention, and treatment by a veterinarian are needed to preserve the human-animal bond, prevent abandonment and euthanasia, and decrease mental suffering of the animal158. The well-established connection of mental and physical health in human medicine is starting to be recognized in the veterinary field as welll159. Chronic stress can contribute to a wide range of physical medical conditions including gastrointestinal, dermatologic, and urinary tract disorders, as well as immunosuppressionl158. Therefore, physical wellbeing is not the only pertinent feature of a healthy patient; behavior problems are equally important for veterinarians to prevent and addressl158. Dogs may be presented to practitioners with a variety of behavioral complaints, including aggression, anxiety, destructive behavior, inappropriate elimination, disobedience, repetitive or compulsive disorders, and cognitive dysfunctionl160. After ruling out a primary medical condition, behavioral problems are best targeted using multimodal therapy. Treatment modalities include owner education with behavior modification training, environmental manipulations,
exercise, and in some cases, pharmacologic interventionsl160. Conventional pharmacologic interventions include tricyclic anti-depressants and serotonin reuptake inhibitors. At high doses, or when used in combination with other drugs that enhance serotonin transmission, a serious and potentially fatal condition known as serotonin syndrome can result. This causes signs of confusion, agitation, hyperthermia, tachycardia, nausea, diarrhea, muscle tremors, and coma. These drugs should not be used concurrently with monoamine oxidase inhibitors or with other antidepressantsl161. Benzodiazepines are additionally used for their short and immediate effectsl162,163. Their therapeutic efficacy, however, is not well established in dogs. Benzodiazepines also have potential side effects, which include ataxia, sedation, paradoxical excitation, disinhibition (leading to an increased possibility of aggression), and a rebound effect on withdrawall164. Therefore, there is a demonstrated need for alternative safe and effective therapeutics in the treatment of persistent behavioral disorders. L-theanine, an amino acid found in green tea that is structurally similar to glutamic acid, causes an increase in the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) along with serotonin and dopamine levels in the brainl165. Data-based studies have shown L-theanine to be effective in dogs to decrease fear of strangersl166, and in cats to decrease anxietyl167. In both of these studies, no side effects related to treatment were seen. A recent study has shown L-theanine to be an effective treatment for behaviors associated with storm sensitivity in dogsl168. In this study, Anxitane® tabletsl169, a nutraceutical supplement composed of a 99.95% pure active L-isomer form of theanine,
were used, and each dog received the labeled dosage. Depending on weight, the dosage ranged from 2.5-5 mg/kg of L-theanine every 12 hours. This study showed minimal to no side effects with only one dog that demonstrated increased anxiety. True Calm contains 25 mg of L-Theanine and uses a comparative dosage of about 2.2-7.7 mg/kg every 12 hours. With this similar dosing regimen, we hypothesize that True Calm will see similar beneficial effects by providing relief from the intensity of common behavior problems. Matricaria chamomilla, commonly known as chamomile, is a plant that is an annual member of the daisy family. Chamomile contains volatile oils, flavonoids, hydroxycoumarins, and mucilagesl170,171. As one of its traditional uses as a sedative tea in humans, chamomile may have use in veterinary behavior medicine for sedative and anxiolytic propertiesl172. Limited information is currently available on its efficacy and dosing in veterinary medicine, but some studies have examined potential mechanisms for anxiolytic activity in ratsl173-175. In humans, results from a controlled clinical trial on chamomile extract for generalized anxiety disorder (GAD) suggests that it have modest anxiolytic activity in patients with mild to moderate GADl176. Inhaled chamomile vaporl177 and chamomile essential oilsl178 have also been found to be beneficial in improving mood/behaviors in humans and dogs respectfully. M. chamomilla preparations are generally regarded as safe and longterm administration in rats, rabbits, and guinea pigsl179,180. In dogs, side effects of vomiting and hypersalivation have been reportedl181. It is important to note that coumarin anticoagulants may be potentiated by chamomile because of its hydroxycoumarin contents; therefore, use of chamomile products with antithrombotics should be avoidedl170.
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Melissa officinalis or lemon balm, is a perennial member of the mint family. Lemon balm contains volatile oil, glycosides, caffeic acid derivatives, flavonoids, and triterpene acidsl170. Historically, lemon balm was used for treating nervousness, insomnia, headache, and other ailmentsl172. Little information is currently available on the efficacy of lemon balm in veterinary patients, but there is a potential for its value in for sedationl182, and prevention/treatment of cognitive decline. With the human medical profession’s growing interest in Alzheimer’s disease, lemon balm has been an attractive nutraceutical due to possible memory improving propertiesl183. In a 2003 study, human patients given lemon balm extract had improved agitation and cognitive scores when compared to controlsl184. Another study concluded dosages of commercial lemon balm extract improved cognitive performance and mood in healthy, young peoplel185. Canine cognitive dysfunction (CCD), a common neurodegenerative condition geriatric dogs, shares several characteristics with human Alzheimer’s disease (AD)l186-188 Restlessness and anxiety are some of the common clinical signs associated with CCDl189 Therefore, lemon balm has potential value in veterinary patients with CCD. Although limited toxicology information is available, especially in dogs, lemon balm has a long history of safe usage in humans, with no adverse side effects reportedl185,190. Additionally, it is important to note that lemon balm products must be carefully sealed and protected from light and moisture, particularly if it is intended for use as a sedative. The shelf life is limited to six months because of the degradation of bioactive componentsl170,180. Behavior problems in dogs are equally as important to address as physical me-
Research #17 | True Leaf Medicine International Ltd.
dical problems. In addition to hempseed meal, the True Calm product line contains L-theanine, chamomile and lemon balm. Currently, there are no studies on the effects of hempseed, L-theanine, chamomile and lemon balm together. The goal of this combination is to provide anti-anxiety and calming effects for dogs with behavior problems. True Calm is meant to be an adjunctive therapy to be used alongside other modalities such as behavior modification training, environmental manipulations, and exercise. It is not intended for use in animals with severe behavior problems. If the dog’s condition worsens or does not improve within thirty (30) days of treatment, please discontinue and consult a veterinarian.
Truelove combines hempseed powder with pomegranate polyphenols and the omega-3 fatty acid, docosahexaenoic acid (DHA), for decreasing the risk of developing cancer and boosting general health. True Calm uses hempseed powder, L-theanine, calming chamomile and lemon balm for anti-anxiety and calming effects. As an adjunctive treatment to conventional therapies, True Leaf’s product line can help enhance the quality of life of dogs.
References
Conclusion Osteoarthritis, cancer, and behavior problems are common issues seen in dogs of all ages. These diseases can be painful, physically taxing, and anxiety provoking, often drastically decreasing our pets’ quality of life. With a multimodal therapeutic approach, nutraceuticals can help in the management of these diseases. Hempseed is a unique source of proteins, fatty acids, cannabidiol, and terpenoids. Individual components of hempseed products have been found to have anti-inflammatory, analgesic, neuro-protective, anxiolytic, and anti-cancer effects. True Leaf’s nutraceutical product line for dogs features hempseed powder in combinations with other active ingredients that compliment these studied benefits. While there are no current studies on the combinations of these active ingredients, information regarding their individual safety and efficacy is available from published sources in both human and veterinary literature. True Spirit combines hempseed powder with green-lipped muscle and curcuminoids for anti-inflammatory joint support.
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154. Bougnoux, P; Koscielny, S; Chajes, V; Descamps, P; Couet, C; Calais, G. Alpha-linolenic acid content of adipose breast tissue: a host determinant of the risk of early metastasis in breast cancer. Br J Cancer. 1994. 70:330-334. 155. Ogilvie, GK; Fettman, MJ; Mallinckrodt, CH; Walton, JA; Hansen, RA; Davenport, DJ; Gross, KJ; Richardson, KL; Rogers, Q; Hand, MS. Effect of Fish Oil, Arginine, and Doxorubicin Chemotherapy on Remission and Survival Time for Dogs with Lymphoma: A Double-Blind, Randomized Placebo-Controlled Study. Cancer. 2000. 88;8:1916-1928. 156. Nutramaxx® Laboratories. “Nutrition Label of Welactin® Canine.” Accessed: 30 January 2016. 157. Butler Schein™ Animal Health. “Nutrition Label of Omega Tri-V Caps For Large Breeds Over 61 lbs.” Dublin, OH. 158. Seilbert, LM; Landsberg, GM. Diagnosis and Management of Patients Presenting with Behavior Problems. Animal
165. Nathan, PJ; Lu, K; Gray, M; Oliver, C. The neuropharmacology of L-theanine (N-ethyl-L-glutamine): a possible neuroprotective and cognitive enhancing agent. J. Herb. Pharmacother. 2006. 6;21-30. 166. Araujo, JA; De Rivera, C; Ethier, JL; Landsberg, GM; Denenberg, S; Arnold, S; Milgram, NW. ANXITANE tablets reduce fear of human beings in a laboratory model of anxiety-related behavior. J. Vet. Behav.: Clin. Appl. Res. 2010. 5;268-275. 167. Dramard, V; Kern, L; Hofmans, J; Halsberghe, C. Clinical efficacy of L-theanine tablets to reduce anxiety-related emotional disorders in cats: a pilot open-label clinical trial. J. Vet. Behav.: Clin. Appl. Res. 2007. 2;85-86. 168. Pike, AL; Horwitz, DF; Lobprise, H. An open-label prospective study of the use of L-theanine (Anxitane) in storm-sensitive client-owned dogs. Journal of Veterinary Behavior. 2015. 10:324-331. 169. Virbac. “Insert for Anxitane® (Suntheanine®) Chewable Tablets.” Fort Worth, TX.
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170. PDR for Herbal Medicines (2nd ed). Medical Economics Company Inc., Montvale, NJ. 2000. 331–335; 461–463. 171. Maday, E; Szoke, E; Muskath, Z, Lemberkovics, E. A study of the production of essential oils in chamomile hairy root cultures. Eur J Drug Metab Pharmacokinet. 1999. 24:303–308. 172. Schwartz, S. “Western Psychoactive Herbs.” Psychoactive Herbs in Veterinary Behavior Medicine. Blackwell Publishing, 2005. 3-92. 173. Shinominya, K; Inour, T; Utsu, Y; Tokunaga, S; Masuoka, T; Ohmori, A; Kamei, C. Hypnotic Activities of Chamomile and Passiflora Extracts in Sleep-Disturbed Rats. Biol Pharm Bull. 2005. 28;5:808-810. 174. Awad, R; Levac, D; Cybulska, P; Merali, Z; Trudeau, VL; Arnason, JT. Effects of traditionally used anxiolytic botanicals on enzymes of the gamma-aminobutyric acid (GABA) system. Can J Physiol Pharmacol. 2007. 85:933-942,. 175. Yamada, K; Miura, T; Mimaki, Y; Sashida, Y. Effect of inhalation of chamomile oil vapour on plasma ACTH level in ovariectomized-rat under restriction stress. Biol Pharm Bull. 1996. 19:1244–1246. 176. Amsterdam, JD; Li, Y; Soeller, I; Rockwell, K; Mao, JJ; Shults, J. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (Chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol. 2009. 29:378-382. 177. Roberts, A; Williams, JM. The effect of olfactory stimulation on fluency, vividness of imagery and associated mood: a preliminary study. Br J Med Psychol. 1992. 65:197–199. 178. Graham, L; Wells, D; Hepper, P. The influence of olfactory stimulation on the behavior of dogs housed in a rescue shelter. App Ani Behavior Sci. .2005. 91:143-153. 179. Mills, S; Bone, K. Principles and Practice of Phytotherapy, Modern Herbal Medicine. Churchill Livingstone; Philadelphia, PA. 2000. 319–327. 180. Russo, E. Handbook of Psychotropic Herbs: A Scientific Analysis of Herbal Remedies for Psychiatric Conditions.
Research #17 | True Leaf Medicine International Ltd.
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Milgram, NW; Cotman, CW. Region-specific age at onset of beta-amyloid in dogs. Neurobiol Aging. 2000. 21:89–96. 187. Landsberg, GM; Nichol, J; Araujo, JA. Cognitive dysfunction syndrome: A disease of canine and feline brain aging. Vet Clin North Am Small Anim Pract. 2012. 42:749–768. 188. Osella, MC; Re, G; Odore, R; Girardi, C; Badino, P; Barbero, R; Bergamasco, L. Canine cognitive dysfunction syndrome: Prevalence, clinical signs and treatment with a neuroprotective nutraceutical. Appl Anim Behav Sci. 2007. 105:297–310. 189. Fast, R; Schutt, T; Toft, N; Moller, A; Berendt, M. An Observational Study with Long-Term Follow-Up of Canine Cognitive Dysfunction: Clinical Characteristics, Survival, and Risk Factors. J Vet Intern Med. 2013. 27:822-829. 190. Wong, AHC; Smith, M; Boon, HS. Herbal remedies in psychiatric practice. Archive of General Psychiatry. 1998. 55:1033–1044.
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