PreticX Optimize Your Flora

Transcription

1 Optimize Your Flora The GI tract microbiome is comprised of bacteria from more than 1,000 species. Understanding how these specific populations of bacteria shift, change, and thrive is providing key insight into a wide-ranging cohort of health concerns. Among them are impaired digestion, reduced immunity, reduced metabolic function, as well as reduced brain functions. Recent research suggests that there is a delicate balance between friendly (generally non-pathogenic) and unfriendly (potentially pathogenic) microorganisms that is integral to good health. Studies have demonstrated that individuals with a particular health deficiency may have a microbial signature that is significantly different than healthy subjects. Therefore, there is great interest in modulating the abundance of specific bacterial communities in the microbiome and to leverage their positive impact on human health.prebiotics can be key to these processes. Probiotics have been one of the fastest-growing market trends in the supplement and functional food industries. Although probiotics have been shown to be effective in managing certain gastrointestinal conditions, they have specific limitations. Probiotics are live organisms that are sensitive to conditions such as heat and stomach acid, which can greatly impact their effectiveness before they are delivered to the GI tract. Clinical studies have demonstrated that prebiotics impact health in much the same way as probiotics do, while being easier to incorporate into the diet than live microbes. Prebiotics can modify microbiota by targeting bacteria that is already present in the large intestine. While the majority of prebiotic products on the market are FOS- and GOS-based ingredients, the newcomer,, stands out with unique properties including low dose efficacy, high tolerability and safety with few side effects, as well as an ability to promote a superior balance through increasing Bifidobacterium and optimizing the Firmicutes/Bacteroidetes ratio. 1

2 What is? is a unique prebiotic that is produced by a patented process and is supported by strong clinical publications with the following unique properties: increases Bifidobacterium as low as 1g/day. provides metabolic reconditioning via increasing Bifidobacterium, and optimizing the Firmicutes/Bacteroidetes ratio. has a positive impact on serum cholesterol, triglycerides and glucose concentrations. is well-tolerated, when compared to other prebiotics. has excellent heat and acid stability. has FDA GRAS status and Structure/Function Claims. is Non-GMO (verified via Non-GMO project). What are Prebiotics? Prebiotics are food ingredients that help support growth of probiotic bacteria. They are defined as selectively fermented ingredients that allow specific changes in the composition and/or activity in the gastrointestinal microflora (1). Prebiotics stimulate the growth and activity of beneficial bacteria in our gut. What are Probiotics? Probiotics are live organisms that reside in the body s digestive system. They are considered good bacteria that support the digestive system by keeping the harmful bacteria in check. Two of the most common and well-known probiotics are Bifidobacterium and Lactobacillus, which are found in probiotic foods, such as yogurt. Products Product Code Description 70% with maltodextrin P7070 Best for RTD, less hydroscopic; best used for capsules and tablets 95% P7095 Best for capsules and tablets with limited volume Liquid P7270 Suitable for all liquid forms of functional foods and beverages 2

3 Human Clinical Research on increases Bifidobacteria with a dosage as low as 1g/day In a 2014 study at the University of California Los Angeles, researchers sought to determine tolerance to and its effects on gut microbiota and whether these changes could be achieved without side effects. The team evaluated efficacy and dose levels of in thirty-two healthy adult subjects in a double-blind, randomized, placebo-controlled study. Subjects received 1g or 2g of or a placebo in daily doses. The study consisted of a two-week run-in, an eight-week intervention, and a two-week washout phase. Stool samples were collected at baseline, after four and eight weeks of intervention as well as two weeks after cessation of the intervention 2. In the high dosage group (2g/ day), Bifidobacterium counts increased 21% from the baseline at 4 weeks and 17% from the baseline at 8 weeks ( p<0.05). In the low dose group (1g/day), Bifidobacterium changes were significantly higher as compared to the placebo group at 8 and 10 weeks (Figure 1A). Similar results were also observed in an earlier study published in the Korean Journal of Nutrition in , where 14 Korean women were randomly assigned to two groups: 1g/day of and 2g/ day of for 28 days. The number of fecal Bifidobacterium were significantly increased after 28 days in the 1g/day intake group (p<0.05). In the 2g/day intake group, the number of fecal Bifidobacterium significantly increased after 7, 14, and 28 days (p<0.05). (Figure 1B) % of increase over baseline Figure 1A # weeks 8 weeks 10 weeks Log cfu/g wet feces Figure 1B g (1.4g of 70%) 2g (2.8g of 70%) Days Figure 1: increases Bifidobacteria with a dosage as low as 1g/day (p<0.05, #p=0.052) 3

4 induced a favorable change in gut microbiota and metabolic biomarkers The role of gut microbiota in a weight management program has been an exciting new direction in research. In a 2006 study 4, researchers at Washington University in St. Louis, Missouri demonstrated a correlation between an unhealthy weight and metabolism and an increased Firmicutes to Bacteriodetes ratio. This increased Firmicutes / Bacteroidetes ratio was shown to increase an individual s capacity to harvest energy from the diet. The conclusion from that study indicated that gut microbiota is a determining factor in healthy weight management. The study also suggested that a diet high in saturated fat and low in fruits and vegetables allows microbes that promote a healthy body weight to be overtaken by microbial colonies more conducive to weight gain 5,6,7. significantly modified the F/B ratios and resulted in metabolic reconditioning in gut microbial compositions The potential for prebiotics, such as, to have an impact on the microbiota of overweight people is also gaining traction. In an in vitro study examining the specificity of on Bifidobacterium and Lactobacillus, researchers determined that activates Bifidobacterium at a much lower dosage than Lactobacillus 8. This observation is again supported by the 2014 UCLA study 2, in which Bifidobacterium was significantly increased without the increase of Lactobacillus (a member of the Firmicutes). Interestingly, the research team also found a significant increase in the B. fragilis strain (a member of the Bacteroidetes) for the high dose (2g/day) group. These findings suggest that supplementation may result in a decrease Firmicutes / Bacteroidetes ratio that is desirable for people with abnormal metabolism. In a follow-up study the effects of supplementation on the gut microbiota in healthy and pre-diabetic individuals were examined in a small population of 16 people with 2g/day dosage 9. Genera associated with pre-diabetic populations were compared between healthy and pre-diabetic participants: the abundance of the genera Enterorhabdus, Howardella, and Slackia was higher in those with pre-diabetic conditions. significantly decreased (or reversed the increase in abundance) of Howardella, Enterorhabdus, and Slackia observed in both healthy and pre-diabetic subjects. Abundance of the species Blautia hydrogenotrophica was lower in pre-diabetic subjects, while increased its abundance in pre-diabetic cases. (Figure 3) These results strongly supported a beneficial role of in metabolic reconditioning of overweight individuals. 4

5 selectively regulated some of the Pre-DM associated bacterial taxa in healthy subjects (n=16) or Pre-DM subjects (n=13) during 8 weeks A 0.4 Healthy subjects 0.4 Pre-DM subjects B Healthy subjects 1.5 Pre-DM subjects 2g/day Howardella Howardella Slackia Slackia C Enterorhabdus Healthy subjects Enterorhabdus Pre-DM subjects D Blautia hydrogenotrophica Healthy subjects Blautia hydrogenotrophica Pre-DM subjects Figure 3: The abundances of Pre-DM associated Howardella (A), Slackia (B), and Enterorhabdus (C) were greatly reduced by in both healthy and Pre-DM subjects. (D) The abundance of healthy associated Blautia hydrogenotrophica was enhanced by in both healthy and Pre-DM subjects. Values are presented as mean ± standard error (SE) P induced a favorable change in biomarker levels in people with diabetes A 2008 study in Taiwan 10 confirmed the ability of to influencing blood sugar levels. Twentysix participants were randomly separated into two groups taking either a placebo or 4g/day of for eight weeks. They were then examined for blood sugar, lipids and oxidative status before and after the supplementation. The group saw significantly reduced levels of blood glucose, HbA1c (glycosylated hemoglobin) and fructosamine after eight weeks as compared to the placebo group. (Figure 4) Blood Glucose (mg/dl) HbA1(% hemogoblin) Insulin (IU/mL) Fructosamine (umol/l) Day 0 Day 28 P< 0.05 Figure 4: significantly reduced the levels of glucose, HbA1c and fructosamine after 8 weeks. (p<0.05) 5

6 significantly decreased serum triglyceride, cholesterol, and glucose concentrations not only demonstrates compelling efficacy in promoting a healthy microbiota, but the ingredient has also been shown to improve biomarkers associated with heart and metabolic health. For example, in the 2007 study, after 28 days in the 2g/day intake group, significantly decreased serum triglyceride, cholesterol, and glucose concentrations (p<0.05) (Figure 2). A B 1g (1.4g of 70%) 2g (2.8g of 70%) mg/100 ml serum Days mg/100 ml serum C D mg/100 ml serum Days mg/100 ml serum Days Figure 2: Effects of intake on serum lipid profiles and glucose concentrations A: Total lipid, B: Cholesterol, C: Triglyceride, D: Glucose. (p<0. 05) 6

7 Conclusion Advancing scientific research continues to demonstrate the importance of a balanced gut microbiome for digestive function, and has shown that an unhealthy balance in the gut microbiome can be a precursor to digestive and overall health concerns. Consumers are beginning to better understand these concepts, and are realizing that their digestive and immune function will decline gradually with age. The use of both prebiotic and probiotic products will see continued momentum. The development of products for healthy digestion is now focusing on prebiotics to create the next generation of foods and supplements for optimal digestive support., a unique prebiotic oligosaccharide, has proven to be a leader in these new application. It features strong clinical data on its ability to increase healthy microflora as well as reduce biomarkers of certain health conditions at a low dosage level that is safe and tolerable. TM is effective at a low dosage and is highly price competitive Ingredients Summary of Scientifically-substandiated Recommendations Minimum Recommended Intake, grams per day 1-2g (Finegold et al, 2014), (Na et al, 2007). 0.7 g (Tomomatsu H, 1994). Studies have used a range of g 1 FOS Up to 10 g (Coussement P. 1999): Optimal intake 10 g (K.M. Tuohy, et al). Minimal daily requirement for an increase in gut Bifidobacteria is 8 g (Menne, et al). 4 GOS 5-15 g per day. </=12 g/day is usually well tolerated (Leena Niittyen, et al Ito M, et al, 1990) 10 Inulin 5-8 g (Kolida S. et al. 2007) g for an American adult (Prebiotic Canada) 5 Table 1: Summary of the minimum required dosage for different prebiotics supported by double-blind, placebo controlled studies 11. 7

8 Application Low dosage of 1 g/day supported by human clinical study Suitable for capsules, tablets, stick packs and liquids Mild, neutral and slightly sweet flavor Stable at a broad ph ( ) and temperature range (80-120⁰C) AIDP Means Quality FDA GRAS Obtained Structure function claims with FDA no objection Kosher Halal ISO 9001 ISO ISO ISO Non-GMO Verified NDI Structure Function Claims Related to prebiotic activities: Xylooligosaccharides () contains a prebiotic fiber. Xylooligosaccharides () increases the number of Bifidobacteria in the colon. Xylooligosaccharides () promotes the growth of healthy bacteria in the colon. Related to gastrointestinal regularity: Dietary fiber in XOS () helps promote intestinal regularity. Dietary fiber in XOS () helps promote a healthy colon. Dietary fiber in XOS () supports colon health. Dietary fiber in XOS () helps healthy regularity. Dietary fiber in XOS () helps maintain good colon health. Dietary fiber in XOS () helps maintain good digestive health. XOS () helps promote intestinal regularity. XOS () helps promote a healthy colon. XOS () supports colon health. XOS () helps healthy regularity. XOS () helps maintain good colon health. XOS () helps maintain good digestive health. TM is a trademark of AIDP and distributed exclusively from AIDP. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. 8

9 References 1. Roberfroid MB. Prebiotics: The Concept Revisited. J Nutr. March 2007; 137 (3 Suppl 2): 830S 7S. 2. S.M. Finegold, Z. Li, P.H. Summanen, J. Downes, G. Thames, K. Corbett, S. Dowd, M. Krak, D. Heber. Xylooligosaccharide increases bifidobacteria but not lactobacilli in human gut microbiota. Food Funct Mar;5(3): M. H. Na and W. K. Kim, Effects of xylooligosaccharide intake on fecal bifdobacteria, lactic acid and lipid metabolism in Korean young women, Korean J. Nutr., 2007, 40, Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. And obesity-associated gut microbiome with increased capacity for energy harvest. Nature, Dec. 2006: Vol. 444; M. Million, M. Maraninchi, M. Henry, F. Armougom, H. Richet, P. Carrieri, R. Valero, D. Raccah, B. Vialettes and D. Raoult, Obesityassociated gut microbiota is enriched in Lactobacillus reuteri and depleted in Bifidobacterium animalis and Methanobrevibacter smithii, Int. J. Obes., 2012; 36: R. E. Ley, P. J. Turnbaugh, S. Klein and J. I. Gordon, Microbial ecology: human gut microbes associated with obesity, Nature, 2006;444: P. J. Turnbaugh, M. Hamady, T. Yatsunenko, B. L. Cantarel, A. Duncan, R. E. Ley, M. L. Sogin, W. J. Jones, B. A. Roe, J. P. Affourtit, M. Egholm, B. Henrissat, A. C. Heath, R. Knight and J. I. Gordon, A core gut microbiome in obese and lean twins, Nature, 2009: 457; Z.Li, P.H. Summanen, T. Komoriya, and S.M. Finegold. Invitro study of the Prebiotic Xylooligosaccharides (XOS) on the growth of Bifidobacterium SP and Lactobacillus SP. Int J Food Science Nutr, Early Online: 1-4. July J. Yang, P.H. Summanen, S.M. Henning, M. Hsu, H. Lam, J, Huang, C. Tseng, S.E. Dowd, S.M. Finegold, D. Heber, Z. Li. Xylooligosaccharides Supplementation Alters Gut Bacteria in Both Healthy and Prediabetic Adults: A Pilot Study, Front. Physiol., 07 August H.S. Wayne, I. Lee, W. Chen, and Y. Chan, Effects of Xylooligosaccharides in Type 2 Diabetes Mellitus, J Nutr Sci Vitaminol, 54, , 2008.Ibid, Food Funct Frost & Sullivan Market report: Price Analysis of Xylooligosaccharides (XOS) in the U.S. Prebiotics Market (2014). (Internal documents, available upon request) 9