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A systematic review assessing the effects of ashwagandha for anxiety and stress response included five randomized controlled human trials. An analysis of results indicated that ashwagandha intervention resulted in greater score improvements than placebo in outcomes shown on anxiety or stress scales, with no observed adverse events.
SHODEN® INDUSTRY-LEADING CONCENTRATION SUPPORTS A MORE RESTFUL NIGHT SLEEP
Shoden® Ashwagandha Extract Shoden is an extract derived from the leaves and roots of the ashwagandha plant. This multi-patented ashwagandha extract is distinguished by its industry-leading concentration of 35% withanolide glycosides. Shoden has been clinically studied for its adaptogenic role in the stress response and for support of a more restful night sleep. Additionally, studies designed specifically to assess the safety of Shoden resulted in no adverse or toxic effects. Company Name’s Ashwagandha Complete contains 240 mg of Shoden per the two-capsule daily dose.
A randomized, double-blind, placebo-controlled trial in adults (N = 60) was designed to assess the stress-balancing effects and the potential mechanism of action of Shoden. Test subjects given 240 mg of Shoden daily for 60 days demonstrated reduced levels of the stress hormone cortisol and the steroidal hormone DHEA-S. There was also an increase of testosterone in male participants. Although other potential mechanisms of action were not investigated, the results of this study suggested ashwagandha has an attenuating effect on the hypothalamic-pituitary-adrenal axis activity in stressed individuals.
Results from a randomized, controlled trial in adult males (N = 57) with moderate fatigue who were given Shoden daily for 16 weeks indicated significant improvements in salivary levels of the steroid hormones DHEA-S and testosterone, which typically decline with age. Additionally, although insignificant, self-reported improvements in fatigue, vigor, and sexual and psychological well-being were documented via questionnaire. No significant difference was recorded for salivary cortisol levels; however, it should be noted that in previous findings serum rather than salivary cortisol was assessed.
To ascertain the effect of Shoden on restorative sleep, healthy subjects (N = 150) were given 120 mg of Shoden daily for 6 weeks in a double-blind, placebo-controlled study. The overall quality of sleep was evaluated using a weekly questionnaire and an assessment of parameters such as sleep latency, sleep efficiency, and total sleep time as measured by a wearable sleep actigraphy diagnostic monitoring device. A significant improvement of sleep measures that define non-restorative sleep were noted in the treatment group when compared to placebo, demonstrating the positive effect of Shoden on encouraging restful sleep
Take one to two capsules daily, or as directed by your healthcare professional.
FORMULATED TO EXCLUDE
Wheat, gluten, yeast, soy, animal and dairy products, fish, shellfish, peanuts, tree nuts, egg, ingredients derived from genetically modified
organisms (GMOs), artificial colors, artificial sweeteners, and artificial preservatives.
*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.
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Diversity of gut microflora is characteristic of a healthy GI microbiome and contributes to overall health and vitality by promoting optimum digestion, assimilation, gut integrity, motility, and efficient removal of toxins and waste. Many internal and external influences, including stress, a poor diet, food sensitivities, medication, environmental factors, and certain disease conditions, can impact the microbial balance within this fine-tuned community. Their impact can allow for potential colonization by pathogenic organisms and disrupt a healthy balance, which can result in adverse effects ranging from GI symptoms to impaired immune response. Probiotics are part of the key to promoting the optimal balance of the microbiome, whether they originate from dietary sources or from supplements. Providing an increased supply of immunoglobulins also encourages a healthy balance of bacteri in the intestine. Due to the link between gut health and systemic health, supporting immunity through enhancement of a healthy GI microbiome balance promotes overall health.
LactoSpore (Bacillus coagulans MTCC5856)
Lactic acid-producing bacteria are suggested to play a role in GI microecology. They prevent the growth of non-beneficial microorganisms through competitive inhibition, generation of non-conducive acidic environments, and production of antibiotic-like substances.B coagulans is a unique lactic acid-producing probiotic strain featuring a thermostable spore coating that enables viability throughout shelf life and the ability to survive gastric secretions intact until reaching the gut. B coagulans has a well-documented safety profile. It received premarket safety approval in Canada in 2014 and has USFDA GRAS status. Furthermore, since its market introduction over 20 years ago, extensive research has suggested several beneficial physiological roles for LactoSpore : GI Health Studies have suggested a role for B coagulans in improvement of both acute and chronic GI symptoms due to abnormalities in intestinal flora. B coagulans is indicated for reducing discomfort of intestinal gas. In a study of adults (n=61) with post-prandial abdominal pain, distention, and flatulence but no GI diagnosis, improvement on a GI symptom rating scale was noted for 10 of 12 variables with significant improvement in three of 12 GI variables. Additional studies have shown efficacy in the management of GI problems associated with infections or the use of antibiotics. The effect of B coagulans on pain, discomfort, and bloating in patients (n=44) with irritable bowel syndrome (IBS) was evaluated over an eight-week period with statistically significant improvements noted from baseline value using a self-assessment score. Adding significance to the benefits for use in IBS, a double-blind, placebo-controlled, multicenter trial evaluating the safety and efficacy of LactoSpore in IBS patients (n=36) over a 90-day period suggested that daily supplementation with two billion spores significantly decreased symptoms of vomiting, bloating, diarrhea, abdominal pain, and stool frequency (P<0.01).This study ultimately resulted in licensure of a Canadian health claim for the use of LactoSpore to address IBS. Hyperlipidemia and Vaginal Health While the evidence base supporting B coagulans is most notable for GI health, effects on maintaining blood lipid levels already within a healthy range have been demonstrated. In an open-label fixed-dose trial of 17 patients with hyperlipidemia, a daily regimen of B coagulans for 12 weeks suggested a significant reduction in total serum cholesterol and LDL cholesterol. The level of HDL cholesterol was marginally increased with no change in serum triglyceride concentrations noted. It has also been suggested that B coagulans plays a role in the beneficial management of non-specific vaginitis.
IgY MaxTM Hyperimmunized Egg Powder
Microbial imbalance occurs when non-beneficial bacteria over-proliferate in the gut, taking up vital nutrients that beneficial flora need to survive. As an innovative approach to modifying the composition of the microbiome, Probio Relief combines LactoSpore with IgY Max to help promote the attachment of beneficial flora and address non-beneficial bacteria by imparting passive immunity in the intestinal tract, thus allowing the beneficial flora to thrive. Decades ago, immunology researchers began investigating the possible health benefits to humans that could be achieved by the consumption of products from hyperimmunized lactating cows and laying hens. Agricultural scientists soon discovered that they could simultaneously immunize a single laying hen against multiple human germs. The resulting avian immunoglobulins, known as IgY, are transferred to the egg yolk, paralleling the way human immunoglobulins (IgG) are passed to the placenta. From this discovery, a new functional food was born: the “hyperimmune egg.” IgY Max is the result of special hyperimmune egg harvesting and processing techniques that result in a polyvalent, immunoglobulin-rich, dried hyperimmune egg food product that can be consumed as a dietary supplement. Hyperimmune egg provides a concentrated source of environmentally specific IgY antibodies and immune-supporting cofactors that can confer passive immunity to those who consume it. There are over 100 patents associated with the production of hyperimmune egg and its use in animals and humans. Additionally, IgY Max is self-affirmed GRAS—a designation that affirms safe consumption—and it holds a Food Additive Master File number.Furthermore, in-vitro, animal, and human studies of hyperimmune egg and IgY have shown that supplemental IgY from hyperimmune egg imparts passive immunity in the intestinal tract. An eight-week open-label pilot study (n=6) utilizing two 500 mg capsules of IgY Max two times per day explored their effect on microbial diversity (through stool analyses) and biomarkers of gut wall integrity (zonulin, histamine, and diamine oxidase) in subjects with mild-to-moderate GI complaints. Subjective data included reports of “a decrease in gas and bloating” and “feeling more energy” suggesting improved quality-of-life measures. Objective markers showed a decrease in gut permeability and an overall increase in beneficial flora. Randomized controlled trials have suggested that IgY plays a significant role in the management of rotavirus-associated diarrhea. In a study of children (n=150) with severe diarrhea who were randomly divided into control, probiotic, and immunoglobulin groups, subjects in the immunoglobulin group had a significantly increased fecal secretory immunoglobulin A (SIgA) level after one day of treatment, a significantly decreased frequency of diarrhea and fecal rotavirus shedding after three days of treatment, and a significantly shorter disease course (4.5±1.0 vs 5.8±1.7 days; P<0.05).These results suggested that although probiotics can reduce intestinal flora imbalance and prevent secondary intestinal bacterial infection, they take a longer time to relieve clinical symptoms and cannot shorten the course of disease. In an additional study, rotavirus-positive children (n=52) were randomized into IgY group and placebo IgY group, with all patients receiving standard supportive therapy for diarrhea. When compared to placebo, the IgY group had statistically significant reduction in oral and intravenous rehydration fluid intake, duration of diarrhea from day of admission, and duration of rotavirus clearance from stool from day of admission. In addition to IgY immunoglobulins, hyperimmune egg also contains immunoregulatory factors that act directly on GI surfaces where they may influence effector cells and also circulate systemically where they act as intercellular communicators. As intercellular communicators, they are responsible for the regulation of a variety of immune, hormonal, and metabolic pathways that have widespread systemic effects. Preliminary studies suggest that these immunoregulatory factors benefit cytokine modulation, joint health, blood lipid metabolism, exercise performance, and overall wellness.
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