Perilla frutescens for prevention of gastrointestinal discomfort. Dr. Sigrid Röchter 5. May 2015 Vitafoods Europe Conference Digestive Health Session
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1 Perilla frutescens for prevention of gastrointestinal discomfort Dr. Sigrid Röchter 5. May 2015 Vitafoods Europe Conference Digestive Health Session
2 Agenda 1. Consumer demand for gut health products 2. Gastrointestinal disorders Structural gastrointestinal disorders Functional gastrointestinal disorders 3. New research for the management of gastrointestinal discomfort linked to inflammation 4. Perilla frutescens leaf extract the natural gut health ingredient Origin Specification Technology/ Science 2
3 1. Consumer demand for gut health products Intestine's impact on general well-being Intestine Nutrient and fluid uptake Immune tolerance Defense against infections Signalling to the brain Prevention of malnutrition Prevention of allergy Prevention of infections Energy homeostasis Mood regulation Maintaining optimal gut health is particularly important to vitality and well-being throughout all stages of life Adapted from Bischoff S.C. Gut health : a new objective in medicine? 3
4 1. Consumer demand for gut health products Approaches to maintaining gut health and to preventing GI discomforts are welcome troughout the world UK: Bowel inflammation 1/250 persons Italy: Constipation 34% children million people affected by digestive diseases annually IBS affects 15.3 million Americans Singapore: Constipation 4% Malaysia: Functional dyspepsia 30% Globally 1.7 billion cases of diarrheal diseases every year. Prevalence of IBD in the total population of Western countries is estimated at 1/1.000 Adapted from Canadean: Understanding the potential of digestive health infredients for consumers (2014) 4
5 1. Consumer demand for gut health products Approximately 10-20% of the world population is affected by GI discomfort. Most of them are female and are reluctant to seek doctors help. Consumer data by Vital Solutions showed: 92% reported that they are not able to wear skinny clothes 72% indicated reduced motivation and that they prefer to stay at home 64% said that they do not feel comfortable to meet with friends Today one third of consumers who are looking for gut health support do not find an effective product which works for them. a big market potential 5
6 1. Consumer demand for gut health products 10 Key Trends in the Business of Food, Nutrition and Health 2015 New Nutrition Business 10 Key Trends in Food, Nutrition and Health
7 Agenda 1. Consumer demand for gut health products 2. Gastrointestinal disorders Structural gastrointestinal disorders Functional gastrointestinal disorders 3. New research for the management of gastrointestinal discomfort linked to inflammation 4. Perilla frutescens leaf extract the natural gut health ingredient Origin Specification Technology/ Science 7
8 2. Gastrointestinal disorders GI disorders can be divided in: (1) Structural GI discomfort Bowel looks abnormal and doesn't work properly Most common structural disorders are inflammatory bowel diseases (IBD) with chronic inflammation of the digestive tract IBD primarily includes ulcerative colitis and Crohn's disease. Both usually involve severe diarrhea, pain, fatigue and weight loss IBD produce destructive inflammation in the intestine (2) Functional GI discomfort Bowel looks normal but doesn't work properly Most common problems affecting the colon and rectum, and include constipation and irritable bowel syndrome (IBS) Typical symptoms of IBS are bloating, rumbling, abdominal pain and cramps, constipation, diarrhea, or constipation alternating with diarrhea 8
9 2. Gastrointestinal disorders GI discomfort linked to inflammation Darmbarriere DC Inflammatory mediators Infektion? Normal gut MO Anti-inflammatory mediators Daily stress, food sensitivity and allergies, infections, genetic preposition, altered gut flora TC Gut inflammation NK Inflammatory mediators (e.g. TNFa, IL-1b, IL-6) Pain & cramps Diarrhea Leaky gut Enhanced risk of infections Enhanced risk of malabsorption IBD Anti-inflammatory mediators, (e.g. IL-10, TGF-b) 9
10 Agenda 1. Consumer demand for gut health products 2. Gastrointestinal disorders Structural gastrointestinal disorders Functional gastrointestinal disorders 3. New research for the management of gastrointestinal discomfort linked to inflammation 4. Perilla frutescens leaf extract the natural gut health ingredient Origin Specification Technology/ Science 10
11 3. Gastrointestinal discomfort linked to inflammation It was shown in a mouse model that Perilla frutescens (L.) leaf extract is able to ameliorate intestinal inflammation The following experiments were carried out in C57Bl/6 mice: 1) Safety evaluation and immunological aspects of long-term intake in mice (7 weeks) 2) Preventive experiment in dextran sulphate sodium (DSS) induced colitis in mice (7 days ) 3) Therapeutic experiment in dextran sulphate sodium (DSS) induced colitis in mice (15 days; 5 days DSS and than 10 days 0.54% PE or water) Groups: 1) control group with 1.5% DSS dissolved in distilled water (n=6) 2) treatment group with 1.5% DSS dissolved in distilled water and 0.54%PE (n=6) Urushima et al. Perilla frutescens extract ameliorates DSS-induced colitis by suppressing pro-inflammatory cytokines and inducing anti-inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol (October 30, 2014). doi: /ajpgi
12 3. Gastrointestinal discomfort linked to inflammation Results: Safety experiment (1) 1. No adverse events such as diarrhea and anorexia 2. No significant difference in body weight gain 3. No significant difference for ALT, triglyceride and total cholesterol 4. AST was significantly lower in the PE group Safety experiment: Weight gain Urushima et al. Perilla frutescens extract ameliorates DSS-induced colitis by suppressing pro-inflammatory cytokines and inducing anti-inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol (October 30, 2014). doi: /ajpgi
13 3. Gastrointestinal discomfort linked to inflammation Results: DSS colitis preventive experiment (2) 1. Degree of weight loss was significantly smaller in the treatment group 2. Colon length as a sign for inflammation was significantly less shortened in the treatment group 3. Significantly better histological score after intake of Perilla extract 4. Serum levels of TNF-a, IL-17A, IL-10 were significantly lower in the PE group 5. No differences in the levels of IL-1b, IL-6, TGF-b DSS colitis preventive experiment weight gain Perilla frutescens extract demonstrated beneficial effects in the prevention of DSS induced colitis Urushima et al. Perilla frutescens extract ameliorates DSS-induced colitis by suppressing pro-inflammatory cytokines and inducing anti-inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol (October 30, 2014). doi: /ajpgi
14 3. Gastrointestinal discomfort linked to inflammation Results: DSS colitis therapeutic experiment (3) 1. Body weight was significantly higher in the Perilla group 2. Colon length as a sign for inflammation was significantly less shortened in the Perilla group 3. Significantly better histological score in the treatment group 4. mrna expression of the inflammatory parameters TNF-a and IL-17A was significantly lower in the intestine of the Perilla group 5. Serum levels of the anti-inflammatory parameter TGF-β were significantly higher in the Perilla group 6. No differences in the serum levels of IL-1b, IL-6, IL-10 DSS colitis therapeutic experiment weight gain Perilla frutescens extract demonstrated beneficial effects in the therapy of DSS induced colitis Urushima et al. Perilla frutescens extract ameliorates DSS-induced colitis by suppressing pro-inflammatory cytokines and inducing anti-inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol (October 30, 2014). doi: /ajpgi
15 Agenda 1. Consumer demand for gut health products 2. Gastrointestinal disorders Structural gastrointestinal disorders Functional gastrointestinal disorders 3. New research for the management of gastrointestinal discomfort linked to inflammation 4. Perilla frutescens leaf extract the natural gut health ingredient Origin Specification Technology/ Science 15
16 4. Perilla frutescens leaf extract Origin The investigated Perilla frutescens leaf extract is commercially available under the brand name Nutrigut Nutrigut is obtained by water extraction out of Perilla frutescens (L.) leaves, an annual edible herbaceous plant native to Asia Perilla frutescens is a member of the family Lamiaceae Its common names are: Shiso (Japan), 紫蘇 Zi Su Ye (China) Perilla, Japanese Melisse or Japanese Basil (USA, Europe) Perilla leaves as well as the Perilla seed oil is used as food and in traditional medicine Traditional medical applications are all linked to respiratory tract and immune system 16
17 4. Perilla frutescens leaf extract Specifications and fingerprint Nutrigut is a proprietary Perilla frutescens leaf extract, standardized on a special flavonoid fraction and its key active ingredient Vicenin 2 and on rosmarinic acid Vicenin 2 (Apigenin 6,8-di-C-diglucoside) 17
18 4. Perilla frutescens leaf extract Technology/ Science Additionally to the previously presented studies further scientific studies have been carried out using the proprietary Perilla leaf extract to investigate the effects on digestive health: Nutritional human study to investigate effects on GI discomfort Ex vivo human study to test anti-inflammatory and immune effects Ex vivo animal study to explore anti-spasmodic effects In vitro study to screen for neuroactive effects In vitro study to screen for prebiotic effects Studies demonstrated that Nutigut combines antispasmodic as well as antiinflammatory effects leading to an immediate, perceptible relief of gastrointestinal discomfort and a balanced gut motility. Buchwald-Werner S., et al., Perilla Extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study. BMC Complementary and Alternative Medicine (2014) Buchwald-Werner S., et al. Investigation of a Perilla frutescens special extract Anti-inflammatory and immune-modulatory properties. AgroFOOD industry hi-tech September/October:23(5) Verspohl, E.J., et al., Testing of Perilla frutescens extract and Vicenin 2 for their antispasmodic effect. Phytomedicine (2013) 18
19 Summary Motility, antispasmodic effects on smooth muscle cells, direct or via the brain-gut cross talk Balanced immune response between Th1 (cellular) & Th2 (humoral) Anti-inflammatory effects with significant reduction of TNFα Scientifically proven beneficial effects for gut health New insights for prevention and in the mucosal wound-healing stage in GI discomfort related to inflammation Prebiotic effects supporting a healthy gut flora 19
20 Acknowledgement Meet us at Vitafoods Booth G51 Thank you for your attention! Vital Solutions GmbH Hausinger Straße 6 D Langenfeld Phone: +49 (0) info@vitalsolutions.biz Dr. Sigrid Röchter All information given in this presentation reflects our current knowledge and interpretation of relevant legislations and legal practice. Vital Solutions expressly disclaims any responsibility for the suitability of this information for products and for any specific or particular purposes intended by the user. Our suggestions do not release Vital Solutions customers from evaluating the individual products as to their legal compliance. Vital Solutions does not assume any liability or risk involved in the use or marketing of its products as the conditions of use are beyond its control. The user of the products is solely responsible for compliance with all laws and regulations applying to the use of the products. 20
21 Vital Solutions - Company introduction Vital Solutions develops innovative condition specific natural ingredients for use in foods and dietary supplements, which serve consumer demands for health products and help to reduce health care costs Based on a market-oriented dynamic strong R&D platform, we focus on the development of natural ingredients which improve quality of human life by feeling good and aging well. Our research is focusing on: Anti-aging Brain health Digestive health & metabolism Over the past 5 years we have created an innovative product portfolio and a pipeline, capable of delivering sustainable sales growth. Market introduction of 4 innovative health care ingredients Set up of an innovative product pipeline of 7 ingredients Global distribution network 21
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