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25. Juli 2016
Research #17Hanf-basierte Tiernahrung
Unternehmensdetails
True Leaf Medicine International Ltd.100 Kalamalka Lake Road, Unit 32Vernon, British Columbia V1T 9G1, KanadaTelefon: +1 778-389-9933 Email: [email protected]
Aktien im Markt: 52.800.371
Kanada-Symbol: MJAktueller Kurs: $0,26 CAD (22.07.2016)Marktkapitalisierung: $14 Mio. CAD
Deutschland Symbol / WKN: TLA / A14NM1Aktueller Kurs: €0,20 EUR (22.07.2016)Marktkapitalisierung: €11 Mio. EUR
Chart Kanada (CSE)
Chart Deutschland (XETRA)
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.
Research #17 | True Leaf Medicine International Ltd.2
21. Juli 2016
Sehr geehrte Aktionäre & Interessengruppen,
ich möchte diese Gelegenheit nutzen, um Sie über die bemerkenswerte Transforma-tion des Unternehmens in den vergange-nen 12 Monaten zu informieren.
Wie Sie wissen, hat das Unternehmen 2013 bei Health Canada einen Antrag auf Lizen-zierung als kanadischer Marihuanapro-duzent 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 Entwick-lung 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 Nah-rungsergänzungsmitteln auf Hanfbasis den Einstieg in die globale 104,9-Milliar-den-Dollar-Heimtierbranche gemeistert. Dieses Sortiment wird in Kanada, den USA und in Europa über Vertriebskanäle für Na-turheilkunde 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 Le-bensqualität 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 kogniti-ve Gesundheit sowie die Gesundheit von Haut und Fell. Hanf ist eine Quelle von Omega-Fettsäuren, Gamma-Linolensäu-re und anderen Stoffen, die für ihre all-gemeine gesundheitsfördernde Wirkung in Menschen und Tieren bekannt sind.
Unsere Strategie zielt darauf ab, Produkte auf den Markt zu bringen, die nach Zu-lassung durch die zuständigen Behörden erfolgreich auf dem Weltmarkt abgesetzt werden können. Das Sortiment an Hanf-produkten 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 Direkt-verkaufs 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 signalisie-ren ebenfalls eine Akzeptanz unserer Stra-tegie und Produkte. In den vergangenen zweieinhalb Monaten stieg unsere Markt-kapitalisierung 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 strategi-schen Ausrichtung könnten in Zukunft wei-tere 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 ak-tuellen Stand unserer Marketing- und Ver-triebsaktivitäten informieren. Wir sehen einer anhaltend erfolgreichen Zukunft ent-gegen. 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 nutzbrin-gende Produkte für Menschen und ihre Haustiere zur Verbesserung ihrer Lebens-qualität anbieten.
Hochachtungsvoll,Michael Harcourt, ChairmanTrue 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
Research #17 | True Leaf Medicine International Ltd.3
By Tim Wall for PetFoodIndustry.com on July 18, 2016; Infographic by Jennifer
Keller, WATT Global Media
As pet food becomes increasingly spe-cialized, 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 ex-ample, 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, im-mune 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
INFOGRAPHIC: Functional dog, cat food and pet treat trends
Consumers’ purchases reflect a concern for their pets’ health
Research #17 | True Leaf Medicine International Ltd.4
the same functional ingredients, like pro-biotics (Lactobacillus bacteria), prebiotic fibers (beta-glucans, manna oligosacchar-ides), nucleotides and omega-3 fatty acids (algae-sourced), applied to pet foods.”
Industry opportunities
With such a wide range of options for catering to the need for functional in-gredients in pet foods, how is the industry taking advantage of such an opportunity?
Companies are individualizing their ef-forts, playing to their strengths and choosing ingredients that will best con-tribute to a complex market.
New functional ingredient concepts come in two different ways:
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 re-searchers to find novel ingredients that could achieve the target goals. This re-quires 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.
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 Leckerbis-sen zur Interzoo Leitmesse für die interna-tionale 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 Hanf-produkte 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 enthülltneue Produktlinie“
Research #7 “Ein wichtiges Puzzle-Stück für den sich anbahnenden Erfolg von True Leaf“
Research #6 “True Leaf hat den kanadi-schen Vertrieb für eigene Hanf-Produktli-nie sichergestellt“
Research #5 “CEO-Interview mit Darcy Bomford“
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
5
Analysten-Profil und Kontakt:
Stephan Bogner (Dipl. Kfm. FH)Analyst
Rockstone Research 8050 Zürich, [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 Dip-lomarbeit über den Goldmarkt ab. Ein Jahr später übersetz-
te 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 #17 | True Leaf Medicine International Ltd.
Research #17 | True Leaf Medicine International Ltd.6
In Rockstone‘s last report, trends in the pet foods industry have been presen-ted 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 addi-tional ingredients in the treats help to emphasize the intrinsic qualities provi-ded 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 disea-ses and causes of lameness in dogs47,48. Osteoarthritis is a painful, inflammatory disease of the joints, which is characte-rized by cartilage degeneration, boney hypertrophy at joint margins, and syn-ovial membrane changes49-51. Dogs are usually stoic animals, and can hide the signs of OA until the disease has pro-gressed significantly. Conventional treatment of OA has relied on drugs that control pain and inflam-mation, like non-steroidal anti-inflam-matory drugs (NSAIDs). NSAIDs treat symptomatically, and can be associated with numerous side effects such as irri-tation of the gastrointestinal tract, renal toxicosis, and hepatic disease (especi-ally in Labradors)52,53. Dogs are often used as research models for osteoarthri-tis in humans, so comparisons for treat-ment options are often made. It has be-en reported that 60–90% of dissatisfied human arthritis patients sought com-plementary 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 multimo-dal 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), ome-ga-3 fatty acids including DHA and EPA, eicosatetraenoic acid, vitamins E and C, and minerals (zinc, copper, mangane-se)55,56.
A 2007 study demonstrated proof of ab-sorption 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 demons-trated anti-inflammatory effects, and GLM extracted lipids have been shown to possess significant cyclooxygenase (COX) and lipoxygenase (LOX-5) inhibi-tory activity58. This indicates that GLM seems to be working on the same me-chanisms as newer NSAIDs58. Additio-nally, GLM may have immune system re-gulatory function, and promote humoral and cellular activity59. The chondroitin sulfate and the other glycosamino-glycans 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 ab-normal 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 hum-ans62-65, chronic lameness in horses66, and arthritis in dogs56,67-69. A 2013 stu-dy56, 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 cli-nical trial in dogs69 used a dose of 20-49 mg/kg/day depending on dog body weight for the first 10 days (loading do-se), 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 bene-ficial 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
Introducing: True Hemp™ HIP+JOINT, HEALTH and CALMING formulations
Research #17 | True Leaf Medicine International Ltd.7
GLM with a loading dosage of approxi-mately 26-66 mg/kg over 10 days, and a maintenance dose of approximately 13-33 mg/kg depending on body weight.Additionally, GLM is reported to have no potential severe side effects in hum-ans62-65, and in dogs56,68,69. In rats, GLM has been shown to have favorable GI to-lerability and unaltered platelet aggre-gation 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 gastroin-testinal 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 polypheno-lic compound commonly found in the household spice turmeric75,76. Curcu-min has been found to be a potent an-ti-inflammatory, antioxidant, antiseptic, and anticancer agent77-79. Additionally it has been shown to have therapeutic po-tential 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-inflammato-ry 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 spe-cies82,83. This is of importance, because the degradation of cartilage results from the combination of mechanical stress and increases of ROS and metallopro-teinases84. Additional studies on mares affected by OA and osteochondritis ha-ve confirmed that curcumin possesses anti-inflammatory activity through the suppression of pro-inflammatory cytoki-nes and catabolic enzymes85.
Two studies86,87 have examined a twice-daily 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 do-se86. The 2012 study, a 20-day study, ob-served that curcumin phytosome (Cur-cuVET®) regulated molecular targets of inflammatory response, including targets additional to those seen with NSAIDs. This study concluded that cur-
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 com-pleted. 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 resu-me with the maintenance dose once a day. Although turmeric extract has been shown to be safe even at very high dosa-ge 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 com-parable to the previously examined do-ses. Other nutraceuticals, like the pre-viously mentioned CurcuVET®, contains 50 mg of Curcumin Phytosome, equa-ting 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. Current-ly, there are no studies on the effects of hempseed, GLM, and turmeric together. The goal of this combination is to pro-mote analgesia, anti-inflammation, and chondroprotection for OA patients.
True Hemp HEALTH Support (True Love™ Formula)
With advancements in veterinary medi-cine, the health and welfare of compa-nion animals is continuously improving, and therefore the longevity of animals is increasing. Aging dogs are common po-pulation 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 pre-vious data, this represented an increa-se 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 ex-ample, 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 “se-nior,” 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 disea-se93-98. 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 indivi-dual 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 cont-raindicated in some conditions, so an in-dividualized and commonly multimodal approach versus a universal approach is recommended91.
Aging dogs have the potential to acqui-re dysfunctions in more than one org-an 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 neuro-logical development and cognition pre-servation102-107, 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 PU-FAs and their mechanisms in reducing inflammation are currently believed to be essential for organ health and func-tion111. Omega-3 fatty acids have been observed to benefit a variety of disea-se processes including hypertension112, renal diseases113,114, arthritis115-117, skin disease118-121, gastrointestinal di-seases122,123, and even cancer124.
Omega-3 fatty acids, especially DHA, ha-
Research #17 | True Leaf Medicine International Ltd.8
ve been researched for years for their roles in cancer prevention and as an ad-junctive therapy. Experimental cancer models indicate omega-3 PUFAs, espe-cially EPA and DHA, may be preventative in the development of carcinogen-in-duced tumors, the growth of solid tu-mors, and the occurrence of cachexia and metastatic disease125-129. DHA ap-pears 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 be-nefit 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 in-terval 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 toxici-ties 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 diagno-sed 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 depen-ding on how much is provided in the ba-se 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 organo-phosphate contamination. The dose of DHA in True Love is comparable to other well-known omega-3 supplements in-cluding 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 distur-bance in the balance between oxidant forces and antioxidant defenses in favor of the oxidants138. Oxidants are formed
as a normal product of aerobic metabo-lism, and in health, animals are equip-ped to deal with that level of oxidative stress. In pathophysiological conditions, however, oxidants, like reactive oxygen species (ROS), can be produced at eleva-ted rates causing damage to crucial cel-lular components, such as proteins, li-pids, lipoproteins and deoxyribonucleic acid (DNA)138,139.
Aging has been shown to inconsistently affect antioxidant status, with decrea-ses, no change, or increases in specific antioxidant compounds140,141. Oxidati-ve 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 defen-se, assist in removing oxidants, and to ultimately help the body to return to an oxidative equilibrium. Studies on oxidative stress and antio-xidants specific to dogs show possible areas for intervention. Viviano et al. found that clinically ill dogs had decrea-sed red blood cell glutathione concen-trations; glutathione being the major intracellular antioxidant in all mamma-lian cells that functions to maintain the cellular redox state144,145. Studies in oncology have seen altered levels of antioxidants in dogs with mast cell tu-mors, and changes in antioxidant capa-city with oxidative stress and significant increases in ROS in dogs with lympho-ma146-148. Kapun et al. found oxidative
stress with increased lipid peroxidati-on in dogs with atopic dermatitis149.
In addition, the brain demonstrates the oxidative nature of aging well. In dogs, brain aging is complex, with both simi-larities and differences when compared to humans91. There are three main rea-sons why oxidative changes are particu-larly 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 oxidati-ve damage, and the third is its limited regenerative capacity, making damage more apparent91,151,152. In one study, a combination of environmental enrich-ment and antioxidants improved clinical signs related to cognitive dysfunction in dogs153. In another study, dogs fed a diet enriched in antioxidants showed im-proved 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 radi-cals; this disrupts the chain oxidation re-actions in cellular components154.
The True Love™ formula contains pome-granate seed extract (PSE), which con-tains polyphenolic compounds called tannins. There are minimal current stu-dies 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-
Research #17 | True Leaf Medicine International Ltd.9
thelial cells155-157. Additionally, pome-granate seed extract has been shown to have protective effects in both che-motherapeutic induced hepatotoxicity in rabbits and rats and nephrotoxicity in rats158,159 True Love™ contains PSE for its antioxidant effects and potential be-nefit 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 the-re can be breed specificities for certain conditions, no one dog is immune. In addition to hempseed meal, the True Love product line contains polyphe-nols and algae-based DHA. Currently, there are no studies on the effects of hempseed, polyphenols, and DHA to-gether. 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 ve-terinarian are needed to preserve the human-animal bond, prevent abandon-ment 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 veteri-nary field as welll159. Chronic stress can contribute to a wide range of physical medical conditions including gastroin-testinal, dermatologic, and urinary tract disorders, as well as immunosuppres-sionl158. 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, destructi-ve behavior, inappropriate elimination, disobedience, repetitive or compulsive disorders, and cognitive dysfunctionl160. After ruling out a primary medical con-dition, behavioral problems are best targeted using multimodal therapy. Treatment modalities include owner education with behavior modification training, environmental manipulations,
exercise, and in some cases, pharmaco-logic interventionsl160.
Conventional pharmacologic interven-tions include tricyclic anti-depressants and serotonin reuptake inhibitors. At high doses, or when used in combinati-on with other drugs that enhance sero-tonin transmission, a serious and poten-tially 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 monoa-mine oxidase inhibitors or with other antidepressantsl161. Benzodiazepines are additionally used for their short and immediate effectsl162,163. Their the-rapeutic 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. Th-erefore, there is a demonstrated need for alternative safe and effective thera-peutics 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 gam-ma-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 stu-dy, Anxitane® tabletsl169, a nutraceuti-cal 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 increa-sed 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 be-havior problems.
Matricaria chamomilla, commonly known as chamomile, is a plant that is an annual member of the daisy family. Chamomile contains volatile oils, fla-vonoids, hydroxycoumarins, and mucila-gesl170,171. As one of its traditional uses as a sedative tea in humans, chamomile may have use in veterinary behavior me-dicine for sedative and anxiolytic proper-tiesl172. 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 clini-cal trial on chamomile extract for gene-ralized anxiety disorder (GAD) suggests that it have modest anxiolytic activity in patients with mild to moderate GADl176. Inhaled chamomile vaporl177 and cha-momile essential oilsl178 have also be-en found to be beneficial in improving mood/behaviors in humans and dogs re-spectfully. M. chamomilla preparations are generally regarded as safe and long-term administration in rats, rabbits, and guinea pigsl179,180. In dogs, side effects of vomiting and hypersalivation have been reportedl181. It is important to no-te that coumarin anticoagulants may be potentiated by chamomile because of its hydroxycoumarin contents; therefo-re, use of chamomile products with an-tithrombotics should be avoidedl170.
Research #17 | True Leaf Medicine International Ltd.10
Melissa officinalis or lemon balm, is a perennial member of the mint family. Lemon balm contains volatile oil, gly-cosides, caffeic acid derivatives, flavon-oids, and triterpene acidsl170. Histori-cally, 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 se-dationl182, and prevention/treatment of cognitive decline. With the human medical profession’s growing interest in Alzheimer’s disea-se, lemon balm has been an attractive nutraceutical due to possible memory improving propertiesl183. In a 2003 stu-dy, human patients given lemon balm extract had improved agitation and cognitive scores when compared to controlsl184. Another study concluded dosages of commercial lemon balm ex-tract improved cognitive performance and mood in healthy, young peoplel185. Canine cognitive dysfunction (CCD), a common neurodegenerative condition geriatric dogs, shares several characte-ristics with human Alzheimer’s disease (AD)l186-188 Restlessness and anxiety are some of the common clinical signs as-sociated 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 re-portedl185,190. Additionally, it is import-ant 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 becau-se of the degradation of bioactive com-ponentsl170,180. Behavior problems in dogs are equally as important to address as physical me-
dical problems. In addition to hempseed meal, the True Calm product line cont-ains 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 pro-vide 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 exer-cise. 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 treat-ment, please discontinue and consult a veterinarian.
Conclusion
Osteoarthritis, cancer, and behavior pro-blems 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 thera-peutic 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 an-ti-inflammatory, analgesic, neuro-protec-tive, anxiolytic, and anti-cancer effects.
True Leaf’s nutraceutical product line for dogs features hempseed powder in combinations with other active ingre-dients that compliment these studied benefits. While there are no current stu-dies 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 curcumi-noids for anti-inflammatory joint sup-port.
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 le-mon balm for anti-anxiety and calming effects.
As an adjunctive treatment to conventi-onal therapies, True Leaf’s product line can help enhance the quality of life of dogs.
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Research #17 | True Leaf Medicine International Ltd.16
