BounceBack      BounceBack® Capsules: Human Clinical Studies

BounceBack® capsules
Physical activity recovery/joint health support supplement.* Gluten-free.

Beta-sitosterol.  Phytosterols (PS) are fats present in plants--mostly in plant oils, nuts and seeds. Because the human body cannot produce PS, they must be obtained through the diet. Epidemiologic studies suggest that phytosterol intake supports good health (1). Processing of plant oils typically reduces their PS content (1). The average consumption of PS in industrialized Western countries is low, about 78 mg/day. Asian countries consume an average of 4 times that amount, about 400 mg/day.

 

This ingredient can be found in the following products: •

BounceBack® capsules

Optimal Support Packets
PLUS™ caplets

References

1. Awad AB, Fink CS. J Nutr 2000;130:2127-30. 2. Ovesna Z, Vachalkova A, Horvathova K. Neoplasma 2004;51:407-14.

Last updated March, 2009

Bromelain, extracted from the stem and fruit of the pineapple plant (Ananas comosus), is an enzyme that digests proteins. It was introduced as a dietary supplement in 1957 and has been used in many clinical trials since then. Bromelain is approved by the U.S. Food and Drug Administration (FDA) as generally recognized as safe (GRAS) (21CFR184.1024).

This ingredient can be found in the following products:  BounceBack® capsules

Campesterol is a plant sterol (phytosterol) found in many foods, including soybeans, peppers, avocados and nuts. It is abundant in vegetable oils, particularly canola oil (1), (2).

References

1. Nutrition Data. 2008. http://www.nutritiondata.com/.

2. Souci SW, Fachmann, W. KH. Food Composition and Nutrition Tables. MedPharm Scientific Pub, 2008.

 Last updated March, 2009

 

Japanese knotweed extract (root) standardized to 20% resveratrol  Polygonum cuspidatum is a large, herbaceous perennial plant native to eastern Asia. Its root extract, huzhang, is a traditional Chinese medicine. Japanese knotweed was first introduced to Europe and North America in the late 19th century. Today it is a commercial source of resveratrol for dietary supplements.

Resveratrol is a naturally occurring antioxidant compound that is also abundant in the vines, roots, seeds and stalks of grape plants. Wine contains resveratrol—a glass of red wine delivers about 0.6-0.7 mg resveratrol (1). From animal studies and limited human studies, it appears that resveratrol is absorbed from the gastrointestinal tract following its ingestion. However, the efficiency of its absorption, as well as its distribution, metabolism and excretion, are not well understood. Much research needs to be done in order to elucidate the pharmacokinetics of resveratrol in its various forms (1)

 

This ingredient can be found BounceBack® capsules

References1. PDR Health Database. www.pdrhealth.com. 2007. Last updated March, 2009

 

Protease (from Aspergillus melleus, Aspergillus oryzae

Proteases are protein-digesting enzymes. While they occur naturally in all organisms, proteases in supplements are typically obtained from safe, non-pathogenic fungi, such as Aspergillus melleus and Aspergillus oryzae. Orally administered protein-digesting enzymes can be detected in human blood, at least to some extent, in their intact, biologically active form (1).

This ingredient can be found in the following products: BounceBack® capsules 

 

Kolac C, Streichhan P, Lehr C-M. Oral bioavailability of proteolytic enzymes. Eur J Pharmacol Biopharm 1996;42:222-32.

Last updated April, 2009

 

 

Stigmasterol is a plant sterol (phytosterol) found in many foods, including chocolate, nuts and avocados. It is abundant in vegetable oils, particularly soy oil (1).

 

This ingredient can be found in BounceBack® capsules

 

References

1. Nutrition Data. 2008. http://www.nutritiondata.com/.

Last updated March, 2009

 

Turmeric extract (root and rhizome) standardized to 95% curcuminoids

The rhizome (horizontal stem—usually underground) of turmeric (Curcuma longa) has long been used in traditional Asian and Ayurvedic medicine (1). Turmeric contains curcumin, volatile oils, sugars, proteins and resins (2).

The disposition of curcuminoids in the human body following oral ingestion is not well understood. Animal studies indicate that is poorly absorbed; absorption appears to be improved when it is taken with food (3). Due to its questionable absorption, curcumonoid supplements are often formulated with bromelain to enhance its absorption (3).

 

This ingredient can be found in BounceBack® capsules

References

1. Funk JL, Oyarzo JN, Frye JB et al. J Nat Prod 2006;69:351-5. 2. Luper S. Altern Med Rev 1999;4:178-88.

3.  PDR Health Database. www.pdrhealth.com. 2007.

Last updated March, 2009

 

Formulation Ingredients

 

Avocado/soy unsaponifiables (ASUs). Unsaponifiables are components of an oil, fat, wax, etc. that are not soluble in water. They include sterols, squalene, carotenoids and the fat-soluble vitamins (vitamins A, D, E and K) (1). Soybean oil unsaponifiables include β-sitosterol, stigmasterol, campesterol, carotenoids and vitamins A, E and K (2). Avocado oil unsaponifiables include sterols (3), carotenoids, and vitamins E and K (2).

 

This ingredient can be found in BounceBack® capsules

 

References

 

1. Bender D. Bender's Dictionary of Nutrition and Food Technology. Boca Raton, Fla: CRC Press, 2006. 2. Souci SW, Fachmann, W. KH. Food Composition and Nutrition Tables. MedPharm Scientific Pub, 2008

3. Lozano YF, Mayer CD, Bannon C, Gaydou EM. Unsaponifiable matter, total sterol and tocopherol contents of avocado oil varieties. J Am Oil Chem Soc 1993;70:561-5.

Last updated March, 2009

 

L-cysteine hydrochloride monohydrate. Cysteine is a nonessential amino acid found in many proteins in the body (1). Cysteine is incorporated into glutathione, which works with vitamin E to protect cells against free radical oxidative damage.

This ingredient can be found in BounceBack® capsules

References

1. Mosby's Medical Dictionary. St. Louis, Missouri: Mosby/Elsevier, 2006.

Last updated March, 2009

 

Microcrystalline cellulose (MC) is a purified plant fiber that is widely used in food products and in dietary supplement tablets to: 1) bind ingredients together, or 2) help the tablet disintegrate properly. 
     Following ingestion, MC is not absorbed by the human body. Because it is not absorbed, it has little potential for toxicity. Consumption of large quantities of cellulose may have a laxative effect, but this is unlikely to be a problem for individuals consuming the small amounts included in dietary supplement tablets (1).

This ingredient can be found in the following products:

   •  BounceBack® capsules
   •  Catalyst™ caplets
   •  MannaCLEANSE™ caplets
   •  Optimal Support Packets
   •  PhytoMatrix® caplets
   •  PLUS™ caplets

 

References

1. Handbook of Pharmaceutical Excipients. Washington, DC: Pharmaceutical Press and American Pharmacists Assn, 2006.

Last updated March, 2009

Silicon dioxide, also known as silica, is added to capsule and tablet formulations to reduce clumping (1). Silica is found in many foods, particularly whole grains (oats and barley), sugar beets, sugar cane, soybeans, turnips, green beans (2). The average intake of silica in adults is 14-21 mg/day (3). The bioavailability of silicate additives is low (4). Silica that occurs in food and water has not been shown to cause any adverse effects (3).

This ingredient can be found in the following products:

   •  Accelerator 3™ capsules
   •  AmbroStart® drink mix
   •  Ambrotose® Complex capsules
   •  BounceBack® capsules
   •  Catalyst™ caplets
   •  EM•PACT®
   •  FiberSlim™ capsules
   •  GlycoBears® tablets
   •  GlycoSlim® chocolate meal replacement
   •  GlycoSlim® vanilla meal replacement
   •  ImmunoSTART® tablets
   •  MannaCLEANSE™ caplets
   •  Optimal Support Packets
   •  PhytoMatrix® caplets
   •  PLUS™ caplets
   •  SPORT™ capsules

 

References

1. The Merck Index. Whitehouse Station, NJ: Merck & Co., 2006. 2. Nutritional Biochemistry and    Metabolism. New York, New York: Elsevier, 1991.

3. Natural Medicines: Comprehensive Database. Stockton, CA: Therapeutic Research Faculty, 2000.

4. Institute of Medicine. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, D.C.: National Academy Press, 2002.

Last updated March, 2009

Soy protein isolate, produced from dehulled, defatted soybean flakes, contains 90%-95% protein and is the purest form of marketed soybean protein. Soy protein is an excellent source of essential amino acids, comparable to cow's milk. Isolated soy protein is commonly added to meat, dairy and infant foods to enhance their protein content (1).

This ingredient can be found in the following products:
   •  BounceBack® capsules
   •  Catalyst™ caplets
   •  GlycoSlim® chocolate meal replacement
   •  GlycoSlim® vanilla meal replacement

 

References

1.Ensminger AH, Ensminger ME, Konlande JE, Robson JRK. The Concise Encyclopedia of Foods and 2.Nutrition. Boca Raton, Florida: CRC Press, 1995.

Last updated March, 2009

Talc, a purified compound containing magnesium and silicon, is added as a lubricant to tablets or as an agent to dilute the ingredients in capsules or tablets. Following oral ingestion, it is not absorbed by the human body; it is thus regarded as an essentially nontoxic material. Safety concerns about talc are associated with excessive inhalation of the powder or its negative effects on open wounds (1).

This ingredient can be found in BounceBack® capsules.

 

References

1. Handbook of Pharmaceutical Excipients. Gurnee, IL: Pharmaceutical Press, 2006.

Last updated March, 2009

Vegetable cellulose. Cellulose is a natural compound found in the cell walls of many plants. Powdered cellulose is added to tablets and capsules for a variety of reasons: to dilute the ingredients in tablets or capsules or to help tablets disintegrate following ingestion. Powdered cellulose is not absorbed systemically following oral ingestion and thus has little potential for toxicity. While consumption of large amounts (i.e., 6 g) may have a laxative effect, this is not a concern for individuals consuming the small amounts used as formulation aids in dietary supplements (1).

This ingredient can be found in the following products:

   •  Accelerator 3™ capsules
   •  Ambrotose® Complex capsules
   •  BounceBack® capsules
   •  FiberSlim™ capsules
   •  GI-PRO® capsules
   •  GI-ZYME® capsules
   •  Manna-C™ capsules
   •  Optimal Support Packets
   •  Phyt-Aloe® capsules or powder

 

Reference

1. Handbook of Pharmaceutical Excipients. Gurnee, IL: Pharmaceutical Press, 2006.

Last updated March, 2009

 

 http://www.mannatechscience.org/files/image/nsf.gif

 

NSF- Certified according to the NSF/ANSI 173 Dietary Supplement Standard—the only American National Standard for dietary supplements. This certification ensures that this product contains only the ingredients indicated on the label and is free of impurities, and that Good Manufacturing Practices (GMPs) were used in the manufacturing facility.

About the formulation ingredients in Mannatech’s products

In order to produce products in forms that are acceptable to consumers and which simultaneously meet Good Manufacturing Practices (GMPs) for safety, quality, uniformity and stability, standard food-grade excipients (formulation ingredients) may be employed in the minimum amounts necessary. Our manufacturers use excipients that meet the criteria to be generally recognized as safe (GRAS) as per the U.S. Code of Federal Regulations (21CFR170.30) and/or meet additional requirements for products designed for foreign distribution.

We are committed to continual improvement in our products. Mannatech actively reviews ingredient and excipient choices in our products and, when viable options exist, elects to reduce, remove or replace ingredients that are identified as suboptimal from either a product performance or consumer perception standpoint. Given the very large production volumes for Mannatech’s products and our commitment to meeting or exceeding GMP standards, all ingredient substitutions require very serious consideration supported by solid technical data and testing. It can often take months or even years for new ingredients, including excipients, to reach the level of safety and performance validation necessary to compete with existing formulation options. Both the Mannatech product development team and our contract manufacturers will continue to seek out and apply valid, new technologies which have demonstrated potential to add consumer value to our products.

 

For more information about the benefits of dietary supplement ingredients, we suggest these online resources:

American Botanical Council Healthy Ingredients (requires registration, but access is free):
http://cms.herbalgram.org/healthyingredients/index.html

Cosmetics Information Provided by the Personal Care Products Council,

www.cosmeticsinfo.org

Council for Responsible Nutrition (free),

www.crnusa.org

International Bibliographic Database on Dietary Supplements (free),

http://grande.nal.usda.gov/ibids/index.php

MedLinePLUS (free)

http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html

Natural Medicines Comprehensive Database (about $10/month fee for access)

www.naturaldatabase.com

Natural Standard (some information is free)

www.naturalstandard.com