At a Glance

More than a decade of research has gone into the development of PGX. While the intricate hormonal, molecular and cellular details of how it works may be complex, the basic principles that make this product effective are very simple. Volume and viscosity are key.

 

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The Science of PGX

History
 
Two of the polysaccharides used in the manufacture of PGX® were known to have a synergistic effect (early 1990s10). Work by researchers at InovoBiologic Inc in Calgary, Alberta made the remarkable discovery that the addition of a specific third polysaccharide led to a product with unexpected developing viscosity that was far higher than any of its individual components. Since the early 2000s, work around the globe has been developing a body of scientific evidence in vivo models on PGX®. Some of these studies are listed below with more in various stages of completion or planning. New studies are an ongoing process in the development of this unique product. Continue to watch Pubmed (http://www.ncbi.nlm.nih.gov/pubmed/) and this web site for new development by InovoBiologic and the Canadian Center for Functional Medicine’s staff working with international researchers.
 
Safety

PGX® has been evaluated by internationally recognized protocols to be remarkably safe. In an OECD 408 safety study (conducted in the USA13), PGX was evaluated at a 5% level in food and found to be safe according to these standards. A Human Tolerance study (conducted in France11) also concluded that PGX was safe and two Genotoxicity study (Ames and MMA) also concluded PGX was safe (conducted in Germany12). A paper based on the Factors Group commitment to monitor its products will be available in Integrative Medicine a Clinician Journal illustrating how safe PGX is. Since 2004, over 250 million softgels have been sold as well as many tens of millions of granular doses.
 
Work with the Burdock Group in the USA led to PGX® achieving Self Affirmed GRAS (Generally Recognized As Safe) status as well as Self Affirmed Medical Food GRAS status. 
 
Proprietary Composition

The method in which soluble fibres are made into PGX® (PolyGlycopleX®) is a proprietary process known as EnviroSimplex®. Each softgel, capsule, granule or powdered product contains the exact balanced ratio of components. All manufacturing, processing and packaging steps meet or exceed government and industry standards and all Good Manufacturing Practices are adhered to. The PGX® composition is patent protected. It is a unique novel complex of natural polysaccharides that complement each other and has been shown to act synergistically9 to form strong interactions resulting in an extremely high viscosity, 3-5 times higher than any currently known single polysaccharide. As mentioned previously, the physiological effects and overall benefits to human health of a soluble fibre are directly proportionate to its viscosity.

In PGX, because the right soluble polysaccharides are combined, they act synergistically to create a stable gel "matrix" that can suspend ingested liquid and nutrients for digestion. When PGX is mixed with food in the gut, the matrix slows digestion and extends the area for nutrient absorption through the stomach and the small intestine. PGX's capacity to capture and suspend nutrients (such as sugars, fat and carbohydrates) is key to its physiological benefits, especially after meal glucose-lowering, as demonstrated in clinical trials.

Slow Viscosity

The viscosity of PGX® develops slowly after mixing with water, with maximum viscosity reached after 60 to 90 minutes. When using PGX meal replacement shakes or granules, this means that it remains palatable when prepared, and develops its full viscosity in the stomach and small intestine. Unlike many other fibres, PGX maintains its highly viscous properties in spite of the influence of stomach acid and digestive enzymes. Developing viscosity is very important as if a product becomes viscous too quickly, hazards may result as well as the product being unpalatable.

Optimum Volume

Studies have shown that the volume from food creates a sense of fullness in the stomach. This sense of fullness triggers the release of various signalling hormones that alert the brain to stop eating. When PGX® is taken before a meal or in a meal replacement, a sense of fullness and satiety quickly develops. PGX studies have shown that the ingestion of PGX quickly affects these signalling hormones in people with diseases related to blood sugar. In the intestine, PGX remains highly volumetric and viscous, delaying in the return of hunger pangs. A paper based on a fifty-four person double blind placebo controlled study conducted in Europe evaluating PGX and Satiety hormones in currently under review for publication in a peer reviewed journal. Significant positive effects for the PGX group will be reported shortly.

Research Results

A randomized, double-blind, placebo controlled trial conducted in Canada investigated the effects of 5 grams of a low-viscosity fibre, 5 grams of a medium-viscosity fibre, and 5 grams of PGX® added to meal replacement drinks for 31 healthy individuals. Ninety minutes after taking the fibre-enhanced drinks, participants were given pizza to consume as much as they wanted. The amount eaten was used as an objective measure of appetite suppression. Those who drank the PGX-based meal replacement consumed the least amount of pizza compared to those who had the low and medium viscosity drinks. Even though the PGX group consumed less, they did not compensate at their next meal1.
 
The effects of PGX as a weight loss aid were also assessed in two weight loss programs conducted at the Canadian Center for Functional Medicine in British Columbia. In each program participants received basic instructions for caloric reduction and exercise, and consumed 5 grams of PGX two to three times per day. One program looked at the effect of PGX on weight loss over a 14 week period in sedentary, overweight or obese adults. There was a significant reduction in average weight (-13.0 pounds), waist circumference (-5.0 inches), and percent body fat (-2.5%). Moreover, these changes were paralleled by a significant decrease in total cholesterol (-18.0%), LDL (-25.0%), fasting glucose (-7.0%) and insulin (-26.0%) levels over a time span of 14 weeks2. Body composition measurements showed most subjects lost body fat with little change to their lean muscle mass and body water. These results will be published in a peer reviewed journal.
 
The second program used a meal replacement with PGX and PGX granules on weight loss in overweight and obese adults over a 10 week period. From the patients who participated, there was an average reduction in weight of 11 pounds and waist circumference of 2.5 inches. Most subjects reported that the meal replacement drink created a sense of satiety and completely controlled their hunger for 3-4 hours.
 
Patients in the weight management group were connected to a Continuous Blood Glucose Monitoring System (CGMS). Results show that those with weight challenges have wide and frequent swings in blood glucose levels. Most overweight and obese subjects had high glycemic volatility at baseline and markedly diminished glycemic volatility after using PGX3.
 
Glycemic Index

The effect of PGX® on appetite and satiety has been demonstrated in double-blind placebo-controlled trials conducted in Canada. In a study presented at the American Diabetes Association Conference in 2006, a three-week program of PGX produced a fifty percent reduction in after-meal insulin levels and a forty percent improvement in insulin sensitivity for participants, along with a significant decrease in after-meal blood sugars. These results will be published in the near future in a peer reviewed journal.

At the Glycemic Index Laboratories in Toronto, researchers found that when PGX was added to foods or beverages it greatly reduced their glycemic index. This means that food taken with PGX can have a substantially lower glycemic impact, and glycemic volatility is reduced within days by taking PGX. These results will be published in the near future in a peer reviewed journal.

Studies on PGX have shown reduced risk factors associated with the Metabolic Syndrome by:
  • Reducing waist circumference and intra-abdominal fat4,5
  • Lowering after-meal and fasting blood sugar levels3,4,6
  • Lowering cholesterol6,7; and
  • Improving insulin sensitivity5. 

Cholesterol Effects

Two studies conducted in Canada showed that consumption of a PGX precursor significantly reduced total and LDL-cholesterol by up to 19% and 29% in individuals with Metabolic Syndrome or diabetes2,6. This effect could be compared with the cholesterol lowering effect of a modest dose of statin drugs. Compared to the cholesterol lowering effects of major gel-forming fibres such as psyllium, oats, or guar8, the PGX precursor had a greater effect, expressed as a change in cholesterol per gram of consumed soluble fibre5. Comparable results may be achieved with considerably less PGX2,6. 
  
Future publications and studies:
 
InovoBiologic Inc, the owner of PGX® are committed to turn PGX® into a global product with a substantial body of evidence for this remarkable product. The following will be happening this year: 

  • A free–living, double-blind placebo controlled study on 60 people conducted in France, completed in 2009 with positive results for women in the PGX group when compared to the inulin group. This has been submitted for publication in a peer reviewed journal.
  • Three in vivo studies evaluating PGX against other soluble and insoluble fibre showed significant positive results for the groups consuming PGX. These have all be submitted for publication in peer reviewed journals.
  • A further three GI studies conducted in Australia in 2009 have shown significant results for PGX softgels and granules. A paper is being prepared and the result will be presented at an International Obesity conference in Europe this year by Professor Jennie Brand-Miller.
  • A further paper on PGX’s unique structure is being written based on extensive scientific work conducted in the United Kingdom.
  • At least 4 other clinical studies are being prepared for 2010/2011 with more to come thereafter.

References

  1. Breitman P, Vuksan V, Lyon M, "Impact of meal replacement viscosity on appetite and ad-libitum food consumption in normal weight adolescents.", Presented at the 8th Annual Canadian Diabetes Association (CDA)/Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference, October, 2004.
  2. Vuksan V, Jenkins DJ, Spadafora P, Sievenpiper JL, Owen R, Vidgen E, Brighenti F, Josse R, Leiter LA, Bruce-Thompson C, "Konjac-mannan (glucomannan) improves glycemia and other associated risk factors for coronary heart disease in type 2 diabetes. A randomized controlled metabolic trial.", Diabetes Care 22(6): 913-919, 1999.
  3. Glycemic Index Laboratories," Effect of Adding or Incorporating PGX® into Commonly Consumed Foods on the Glycemic Index.", Winter Report, January 25, 2007.
  4. Lyon MR, Reichert RG., "The effect of a novel polysaccharide blend (PGX™ granules) on weight loss and other laboratory parameters in mild to moderately obese adults: an observational retrospective clinical analysis.", Unpublished.
  5. Vuksan V, Sievenpiper JL, Xu Z, Wong EY, Jenkins AL, Beljan-Zdravkovic U, Leiter LA, Josse RG, Stavro MP., "Konjac-Mannan and American ginseng: emerging alternative therapies for type 2 diabetes mellitus.", J Am Coll Nutr. 20: 5 Suppl, 370S-380S; discussion 381S-383S, Oct, 2001
  6. Vuksan V, Sievenpiper JL, Owen R, Swilley JA, Spadafora P, Jenkins DJ, Vidgen E, Brighenti F, Josse RG, Leiter LA, Xu Z, Novokmet R., "Beneficial effects of viscous dietary fibre from Konjac-mannan in subjects with the insulin resistance syndrome: results of a controlled metabolic trial.", Diabetes Care 23(1): 9-14, 2000.
  7. Rogovik A, Jenkins AL, Breitman P, Vuksan V., "A blend of highly viscous polysaccharides decreases relative CVD risk in three population groups.", Presented at Natural Health Product Research Conference, Toronto, 2006.
  8. Brown L, Rosner B, Willett WW, Sacks FM, "Cholesterol-lowering effects of dietary fibre: a meta-analysis.", Am J Clin Nutr. 69(1): 30-42, 1999.  
  9. An analytical ultracentrifuge study on ternary mixtures of konjac Glucomannan supplemented with sodium alginate and xanthan gum
    Ali Saber Abdelhameed, Shirley Ang, Gordon A. Morris , Ian Smith, Chris Lawson, Roland Gahler, Simon Wood, Stephen E. Harding  Carbohydrate Polymers (2010), doi:10.1016/j.carbpol.2010.01.043
  10. Shatwell, K. P., Sutherland, I. W., Ross-Murphy, S. B., & Dea, I. C. M. (1991). Influence of the acetyl substituent on the interaction of xanthan with plant polysaccharides – III. Xanthan- konjac mannan systems. Carbohydrate Polymers,14, 131-147.
  11. Carabin IG, Lyon MR, Wood S, Pelletier X, Donazzolo Y, Burdock GA. Supplementation of the diet with the functional fiber PolyGlycoplex(R) is well tolerated by healthy subjects in a clinical trial. Nutr J. 2009; 8 (1): 9.  
  12. Palma Ann Marone, Michael Lyon, Roland Gahler, Claudia Donath, Hana Hofman-Hüther and Simon Wood. Genotoxicity Studies of PolyGlycopleX (PGX)® : A Novel Dietary Fiber. Int J Toxicol 2009; 28; 318
  13. Carabin IG, Lyon MR, Wood S, Pelletier X, Donazzolo Y, Burdock GA. Supplementation of the diet with the functional fiber PolyGlycoplex(R) is well tolerated by healthy subjects in a clinical trial. Nutr J. 2009; 8 (1): 9.