Post on 11-Jun-2020
APPROVED U.S. ADVANCED AMBROTOSE POWDER CLAIMS January 2018
MANNATECH, INCORPORATED Page 1 U.S. Advanced Ambrotose Powder Approved Claims
Products Advanced Ambrotose® powder
Country United States
Product Numbers 33201: 120 grams Advanced Ambrotose powder 33301: 60 grams Advanced Ambrotose powder
Effective January 2018 Supersedes October 2016
4 GRAMS/DAY ADVANCED AMBROTOSE POWDER Quality and Safety
Naturally gluten-free Gluten-free Low glycemic No genetically modified DNA
Cellular Communication
Supports cellular communication* Intake of Ambrotose powders significantly modified the N-glycosylation profiles of serum
glycoproteins* Clinical studies have shown that Ambrotose powders can significantly modify the sugars
attached to serum glycoproteins* Ambrotose products are the first dietary supplements shown to impact the N-glycosylation
profile of human serum glycoproteins* Designed to support cellular communication, Ambrotose powders have been shown to affect
serum protein glycosylation*
Immune System Benefits
Preliminary evidence suggests that superior immunologic benefits may be provided by the ingestion of higher molecular weight polysaccharides*
Rich in high molecular weight polysaccharides Rich in polysaccharides >1.4 million daltons Contains a standardized amount of high molecular weight acetylated mannans
®TM
Free from soy, dairy, artificial flavors, artificial colors, MSG, preservatives Naturally sourced Contains naturally sourced ingredients Kosher Patented formulation Suitable for vegans
MANNATECH, INCORPORATED Page 2 U.S. Advanced Ambrotose Powder Approved Claims
Contains a standardized amount of acetylated mannans ≥1 million daltons Includes a standardized amount of the very high molecular weight Acemannan polysaccharides
(1-2 million daltons) as defined by the American Chemical Society Ambrotose powders can [support, improve, bolster, enhance, activate] [the/your] body’s immune
response to vaccinations against bacterial infections* May help keep your immune system strong year* Safe and natural daily supplement for year-round immune system-support*
o Take [Ambrotose complex powder/Advanced Ambrotose powder] regularly for year round immune system support, especially during the winter months when our immune systems are particularly challenged*
Daily intake of Ambrotose powders may help keep your immune system strong year-round* o Take [Ambrotose complex powder/Advanced Ambrotose powder] regularly to help
keep you healthy year-round* Can enhance your body’s response to vaccinations*
o Take [Ambrotose complex powder/Advanced Ambrotose powder] for about two months before your next vaccination to [bolster/improve/enhance] your immune system’s response*
o Taking [Ambrotose complex powder/Advanced Ambrotose powder] regularly can [bolster/improve/enhance] your response to vaccinations*
[Stimulates/boosts/bolsters/enhances/activates] [your/the] immune system* May [Support, improve, bolster, enhance/activate] [the/your] body’s ability to respond to
pathogens* [Supports, improves, bolsters, enhances, activates] [the/your] body’s ability to respond to
bacterial vaccines* Modulates and supports your body’s immune response* Supports the innate immune response* May improve the adaptive immune response* Daily intake of Ambrotose powders can help keep your immune system strong year-round* Taking Ambrotose powder daily can [stimulate/boost/bolster/enhance/activate] your immune
system* May improve overall wellness* Supports [the/your] body’s natural immune response* Supports healthy immune function* Supports a healthy immune response* Supports a healthy immune system* Dietary polysaccharides in Ambrotose powders, including arabinogalactans, fucoidans and
glucans, have been shown to have immunomodulatory activities in controlled studies with human subjects*
Dietary polysaccharides in Ambrotose powders have been shown to elicit immunomodulatory effects in controlled studies of human subjects*
Rich in plant polysaccharides that may support a healthy immune system* In a clinical trial, intake of polysaccharides in Ambrotose powder was shown to support the
body’s natural defenses to help people stay healthy* Includes plant fibers for immune system health* Studies suggest that dietary fiber supports a healthy immune system Supports [the/your] body’s natural immune response*
APPROVED U.S. ADVANCED AMBROTOSE POWDER CLAIMS January 2018
MANNATECH, INCORPORATED Page 3 U.S. Advanced Ambrotose Powder Approved Claims
Supports healthy immune function* Supports a healthy immune response* Supports a healthy immune system*
Cognitive
In a small double-blind, placebo-controlled clinical trial, Ambrotose complex powder taken for 12 weeks significantly enhanced immediate recall and recognition memory in middle aged adults*
In a small double-blind, placebo-controlled clinical trial, Ambrotose complex powder taken for 12 weeks significantly improved mood and decreased irritability in middle aged adults*
In a double-blind, placebo-controlled clinical trial, Ambrotose powder significantly improved memory and mood*
In a double-blind, placebo-controlled clinical trial, Ambrotose powder significantly improved well-being*
In a double-blind, placebo-controlled clinical trial, Ambrotose powder significantly improved a positive outlook*
In double-blind, placebo-controlled clinical trials, Ambrotose powder significantly improved memory*
In a double-blind, placebo-controlled clinical trial subjects who took Ambrotose complex powder reported improved sleep, and increased calmness, concentration and clear-headedness*
May enhance recall and recognition memory* May improve mood and decrease irritability* May improve mood and enhance memory* Improves mood* [Enhances/improves/boosts/supports] memory* [Enhances/improves/boosts/supports] brain function* [Enhances/improves/boosts/supports] cognitive function* Improves perceived psychological well-being* May improve psychological well-being* Improves well-being* Improves perceived quality of-life* May improve quality-of-life* Prevents mental stress* Mitigates cognitive fatigue* May improve visual discrimination* May improve cognitive function* Helps support cognitive function*
Fiber
A blend of plant-sourced polysaccharides A source of dietary fiber
APPROVED U.S. ADVANCED AMBROTOSE POWDER CLAIMS January 2018
MANNATECH, INCORPORATED Page 4 U.S. Advanced Ambrotose Powder Approved Claims
A source of soluble fiber Ambrotose products contain complex polysaccharides (including arabinogalactan) Adds to your daily fiber intake
Gastrointestinal/Prebiotic
Prebiotic dietary supplement Supports the growth of good gut bacteria* Supports the growth of good gut bacteria* Helps promote gastrointestinal health* Helps support proper digestive system function* The complex polysaccharides in Ambrotose powders increase the number of beneficial bacterial
in the gut* Individual ingredients in Ambrotose powders demonstrate prebiotic effects. For example,
arabinogalactan can be fermented by human colonic bacteria and enhance the growth of Lactobacillus species, including Lactobacillus plantarum*
Research indicates that the larch arabinogalactan in Ambrotose powders supports the proliferation of Lactobacillus plantarum, a beneficial bacteria found in the colon and lower GI tract*
The arabinogalactan in the Ambrotose powders may be broken down and utilized by specific bacteria found in the intestines, including Lactobacillus plantarum and Bifidobacterium longum
Research indicates that the larch arabinogalactan in Ambrotose powders supports the proliferation of beneficial bacteria found in the colon*
Research indicates that the larch arabinogalactan in Ambrotose powders supports the proliferation of Lactobacillus plantarum*
Ambrotose powders have been found to have a bifidogenic and lactobacillogenic effect, increasing the number of these beneficial bacteria*
In a state-of-the art in vitro model, Advanced Ambrotose significantly increased the number of beneficial bacteria (Bifidobacteria and Lactobacilli) in the colon*
Research using a state-of-the-art simulation of the human gastrointestinal tract showed that Ambrotose powders can increase the numbers of the beneficial bacteria Bifidobacteria, as well as species belonging to Bacteriodetes, a phylum recently associated with body weight management*
Ambrotose powders are effective prebiotic supplements, able to be [digested/fermented] by human colonic bacteria and promote the growth of beneficial bacteria*
In August 2007, Mannatech scientists published research in the International Journal of Probiotics and Prebiotics that showed naturally-occurring bacteria in the GI tract can digest Ambrotose ingredients into small fragments
General statements
About Prebiotics
GI tract bacteria, such as Lactobacilli and Bifidobacteria, are important for GI health* GI tract bacteria decrease the growth of pathogenic bacteria and increase production of short
chain fatty acids in the gut, both of which are believed to be positive for GI health. Lactobacilli and Bifidobacteria are bacteria known to be important for GI tract health*
APPROVED U.S. ADVANCED AMBROTOSE POWDER CLAIMS January 2018
MANNATECH, INCORPORATED Page 5 U.S. Advanced Ambrotose Powder Approved Claims
Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of beneficial bacteria in the colon, thereby supporting host health*
Currently identified prebiotics are oligosaccharides, which exert prebiotic effects in the promixal colon but are unlikely to exert prebiotic effects throughout the colon
About Glycosylation
Glycosylation is the enzymatic process that attaches sugars (glycans) to proteins, lipids, or other organic molecules. These attached sugars can be structural and/or functional. In their functional role, they serve as antennae, interacting with cellular receptors and thus affecting cellular processes
Sugars attached to proteins (glycoproteins) serve as signals in cellular communication, thus influencing processes involved in inflammation and immunological reactions*
Glycosylation is a key post-translational protein modification that can significantly affect the overall biophysical and biochemical functions of proteins
The function of glycoproteins is profoundly affected by their component sugars Modifications of glycoproteins results in changes in their structure, with ensuing modulation of
molecular and cellular signaling processes. Changes in signaling processes can result in changes in cellular interactions, including those involved in immunological and inflammatory processes*
Sialylation of glycoproteins affects their immunogenic properties, as well as absorption, half-life and clearance*
ADVANCED AMBROTOSE-ONLY POWDER CLAIMS
Prebiotic
Advanced Ambrotose powder demonstrated prebiotic activity in vitro by increasing levels of beneficial bacteria and short chain fatty acids in the gut*
Advanced Ambrotose powder increases short chain fatty acids in the gut* In a state-of-the-art simulation of the human gastrointestinal tract, Advanced Ambrotose
powders was fermented by bacteria throughout the entire colon, indicating a great potential for providing health benefits*
Recent research indicates that Advanced Ambrotose powder exerts prebiotic effects throughout the entire colon providing support for beneficial bacteria*
In a state-of-the-art in vitro study, Advanced Ambrotose powder significantly increased the number of Bifidobacteria in the distal colon*
In a state-of-the-art in vitro study, Advanced Ambrotose increased the number of Lactobacilli in the ascending and transverse colon*
Beta-carotene
APPROVED U.S. ADVANCED AMBROTOSE POWDER CLAIMS January 2018
MANNATECH, INCORPORATED Page 6 U.S. Advanced Ambrotose Powder Approved Claims
Advanced Ambrotose powder includes beta-carotene for immune system health* Advanced Ambrotose powder includes beta-carotene and plant fibers for immune system health* Intake of sufficient amounts of beta-carotene is important for immune system health As modern diets may be low in beta-carotene, Advanced Ambrotose powder supplies that added
boost to help ensure a healthy immune system*
Serum glycosylation
Although the clinical significance has yet to be determined, servings of 1.3 g to 5.2 g of Advanced Ambrotose significantly modified the N-glycosylation profiles of serum glycoproteins in healthy subjects*
In healthy subjects, intake of Advanced Ambrotose dose-dependently shifted glycoproteins towards silaylation. Although the biological significance of this effect has yet to be established, there is evidence that increased levels of sialic acid can affect the biological properties of glycoproteins. Changes in sialylation may affect aspects of immune and inflammatory interactions, as well as absorption and elimination, of glycoproteins*
Advanced Ambrotose dose-dependently shifted plasma glycoproteins towards silaylation. Changes in sialylation may affect aspects of immune and inflammatory interactions. As cellular interactions are involved in immune and inflammatory processes, the effects of Advanced Ambrotose on plasma glycoprotein may translate to an effect on these interactions*
Intake of Advanced Ambrotose powder can result in significant serum protein glycomodifications in healthy adults*
In an open-label study of healthy adults, intake of Advanced Ambrotose powder significantly increased sialylation of serum glycoproteins*
According to Dr Alvai’s team at St George’s University of London, UK, their 2009 study that demonstrated that plant-derived polysaccharides in Advanced Ambrotose® powder can significantly alter serum N-glycosylation changes is the first study to investigate the impact of dietary changes on serum glycosylation patterns
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
APPROVED U.S. ADVANCED AMBROTOSE POWDER CLAIMS January 2018