2010

NOTICE OF AGAVE
DELISTING

AGAVE PRODUCTS & AGAVE CHOCOLATE
DE-LISTED & BANNED BY THE
GLYCEMIC RESEARCH INSTITUTE®



The Glycemic Research Institute® announced that they have legally “De-Listed” and placed a ban on Agave and Agave Nectar for use in Foods, Beverages, Chocolate, and any other products, due to results of 5 years of Human In Vivo Clinical Trials on Agave.

Manufacturers who produce and use Agave and Agave Nectar in products are now warned that they can be held legally liable for negative health incidents related to ingestion of Agave.




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AGAVE DANGERS
RESULT IN DELISTING
& BANNING

Agave Clinical Trials Halted Due to
Severe Side Effects in Diabetics



The Glycemic Research Institute® announced that they have halted and banned all future clinical trials of Agave and are issuing warnings to manufacturers and the public about the dangers related to Agave and Agave Nectar.

The Medical Advisory Board of the Glycemic Research Institute® (GRI) made the decision to halt all future clinical trials involving Agave and Agave Nectar as a result of the latest round of GRI Human In Vivo Clinical Trials, in which the diabetic subjects experienced severe and dangerous side effects related to the oral ingestion of the sweetener Agave/Agave Nectar.

This announcement came as a surprise to the scientific community, and has generated hundreds of inquiries involving the safety of ingesting Agave.

Physicians and diabetes health educators are now being advised to caution their diabetic patients, both adults and children, about the use of Agave.

This also applies to persons with Metabolic Syndrome, Insulin Resistance, and Pre-Diabetes. The medical community believes that up to 70% of the American public has some form of Insulin Resistance, due to the rise in obesity and weight gain.

The ban on Agave and agave Nectar includes “The use of Agave as a sweetener and/or syrup, and/or Agave Nectar, as found in foods, beverages, Nutraceuticals, chocolate, and any other consumable product.”

CLINICAL TRIALS RESULT IN
DELISTING & BAN


Results of the Human In Vivo Clinical Trials involving Agave/Agave Nectar resulted in alarming effects evidenced in the diabetic trial subjects.

According to the researchers, the side effects seen in the diabetic population are related to dosage. Very small amounts of orally ingested Agave did not instigate immediate side effects in diabetics, while larger doses caused severe side effects.

The Glycemic Research Institute® is legally bound to alert the appropriate government and health authorities, as well as the public, of any clinical trial results that pose a health problem to the public-at-large.

The Wall Street Journal interviewed researchers at the Glycemic Research Institute® in 2009 (article available at Wall Street Journal online), when results of the Agave trial were made public.

As of 2009, manufacturers and marketers of products containing Agave and/or Agave Nectar can now be held legally responsible for any negative medical issues resulting from ingestion of Agave. The legal community has contacted the Glycemic Research Institute® for verification and documentation that Agave does elicit negative results in person with blood-sugar and other related metabolic issues, and are prepared to take these issues to court.

METABOLIC RESPONSE OF
AGAVE IN DIABETICS


The Glycemic Research Institute® Agave trials, as well as other independent data and research, demonstrate that diabetics respond differently to oral ingestion of Agave than non-diabetics and persons with normal glycemic responses.

The biochemical reason is that all cells in the body, including liver, muscle, and brain cells, are dependent on glucose as fuel. Glucose is not capable of diffusing from the bloodstream into the cells, and requires specialized proteins (not dietary protein) to transport it across cellular membranes.

Insulin is the catalyst for the cell-transporters that deliver glucose into heart, muscle, and fat cells. Excess insulin causes adipose tissue fat storage via Lipoprotein Lipase (LPL), so foods and beverages that stimulate insulin cause weight gain and obesity. This explains why Type 1 diabetics (lack of insulin) are thin and Type 2 diabetics (excess insulin) are almost always overweight or obese.

The brain, however, works on a different fuel-basis. Glucose can get into the brain to act as fuel (glucose-transport), while insulin cannot, and fat-storage in the brain is not an option. The Blood-Brain-Barrier (BBB) is the watch-dog in the brain that is responsible for regulating the amount of sugar/glucose going to cells inside the brain. The BBB only allows very specific agents to enter the brain by crossing the Blood-Brain-Barrier (BBB).

In diabetics, muscle cells cannot obtain sufficient energy to function normally, because the diabetic’s ability to properly produce and/or utilize insulin is impaired. Diabetic serum levels of glucose are consistently over-elevated, yet muscle cells are stressed and starving.

Diabetics using insulin-treatments (medication) often experience excess insulin stimulation and uptake, resulting in insufficient levels of glucose in the bloodstream.

Imbalances in blood glucose and insulin levels are the standard trademark of a diabetic patient. In type 2 diabetes (by far the most common form of diabetes), high blood glucose levels cause weight gain and obesity, which exacerbates insulin resistance, risk of cardiovascular disease, and shortened lifespan. High insulin levels further trigger weight gain and obesity, as well as a myriad of health problems.

These imbalances are problematic in the diabetic, as every food, meal, snack, beverage, or orally ingested agent, causes a glycemic reaction, ranging from mild to severe.

High glycemic foods, beverages, and sweeteners stimulate high levels of serum glucose, which makes diabetics susceptible to neurological and physical problems, including stroke and memory loss.

In a hyper-insulin state, which is triggered by ingesting foods, beverages, and sweeteners that over-stimulate insulin, muscle cells take up all of the available glucose, thus depriving the brain of sufficient fuel.

This causes severe Metabolic Low Blood Sugar, resulting in wooziness, poor motor and thinking function, extreme lethargy, and in many cases, lack of consciousness (fainting/passing out).

Even foods and beverages that claim No-Calories, No-Carbs, cause a reaction in the diabetic and pre-diabetic.

This is because the human brain has to contend with high and low levels of glucose in the blood stream. Severe imbalances, including very low levels of glucose, and reactive hypoglycemia, can place diabetics in a precarious physical condition, in which there is literally a “brain shut-down.”

This type of metabolic cascade causes severe diabetic reactions, including passing out – even behind the wheel of a car while driving, and explains why oral ingestion of Agave induces potentially dangerous metabolic states in diabetics.

IN SUMMARY: Diabetics and persons with any insulin-related disorder, including Pre-Diabetes and Insulin Resistance, are urged to use extreme caution as related to oral ingestion of Agave and Agave sweeteners and syrups.


MEDIA & MEDICAL INQUIRIES

Medical and/or media-related questions may be addressed to the Glycemic Research Institute, Human in Vivo Clinical Trials Facility at (727) 894-6900 or via e mail from the Official Glycemic Research Institute® website at www.Glycemic.com






Official Agave Press Release
Copyright© 2009-2010
Last Update: June 3, 2010

www.Glycemic.com

www.GlycemicResearchLaboratories.com

No copies of this article may be made without prior express written permission from the Glycemic Research Institute









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OCTOBER 29, 2009

UPDATE
Agave Clinical Trials
Halted Due to Severe Side Effects in Diabetics


The Glycemic Research Institute® announced today that they are halting all future clinical trials of Agave until researchers have discovered why an Agave product caused severe side effects in diabetics.


The Medical Advisory Board of the Glycemic Research Institute® (GRI) made the decision to halt all future clinical trials involving Agave as a result of the latest round of GRI Human In Vivo Clinical Trials, in which the diabetic subjects experienced severe and dangerous side effects related to the oral ingestion of an Agave product.

This announcement came as a surprise to the scientific community, and has generated hundreds of inquiries involving the safety of ingesting Agave products.

Results of the Human In Vivo Clinical Trials involving a Volcanic Nectar Blue Agave product resulted in alarming effects as evidenced in the diabetic trial subjects.

Researchers at the Glycemic Research Institute (GRI) are currently examining the data to determine why this abnormal reaction was seen in the diabetic test subjects. In the interim, they will not be conducting clinical trials for Agave products.

According to the researchers, causes of the side effects evidenced by the diabetic subjects have been narrowed to the following:

1) Dosage of the Agave test food (high levels of Agave)
2)
The label of the product, data, and/or documents supplied to GRI by the company that submitted the product (Volcanic Nectar Blue Agave Maple Syrup) were not accurate
3)
The Agave product submitted by the client contained ingredients not disclosed
4)
Inulin content of the product tested varies from original trials


DOSAGE: As of October 2009, prior clinical trials conducted globally on Agave and Agave products appear to have been limited to lower doses, administered to non-diabetic subjects. As of October 2009, we can find no evidence of Human in Vivo Clinical trials conducted on diabetics at higher doses, other than the trials conduced by the Glycemic Research Institute.

According to the data published at the University of Sydney (October 29, 2009), three glycemic trials have been conducted by the Human Nutrition Unit/Sydney University/Australia, on Agave, and none of those trials list diabetics as the test subjects (all are listed as normal test subjects), and none of the trials listed high serving sizes of Agave.

Two of the trials utilized Western Commerce Corporation Organic Agave Cactus Nectar.

According to published information on the Internet:

“In 2000, with warrants in hand, federal agents from the Office of Criminal Investigations of the Food and Drug Administration (FDA) came banging on the door of North America's largest agave nectar distributor, Western Commerce Corporation in California. In an extremely rare case of the FDA protecting consumer interests (rather than supporting big business, while shutting down legitimate and health consciousness competition), they discovered that Western Commerce Corporation was adulterating their agave syrup with high fructose corn syrup (to lower the cost even more and increase profit margins). While the federal agents confiscated the material in the warehouse, the owners of Western Commerce Corporation were nowhere to be found. Those who ran the company fled the country with millions of dollars in assets to avoid criminal prosecution.”

The third Agave trial published at the Human Nutrition Unit/Sydney University/Australia, was limited to normal and not diabetic subjects, and the dose fed to the test subjects was listed as 8 grams of carbohydrate per serving from the Agave product.

These prior trials cannot be directly compared to Human In Vivo Clinical Trials utilizing diabetic subjects at higher doses of ingested Agave.

GRI urges that researchers who have conducted Board Approved Agave Human In Vivo Clinical Trials utilizing diabetics and serving sizes over 10 grams Agave/8 g carbs, come forth with their trial information.

VARIATIONS IN AGAVE PRODUCTS: According to many sources, the refined fructose in Agave Nectar is much more concentrated than the fructose found in High Fructose Corn Syrup, which could account for the diabetic side effects at higher doses.

INULIN: On average, 25 percent of Agave’s weight is inulin. Inulin/Polyfructoses are typically considered a dietary fiber (Report of the Committee on Definition of Dietary Fiber of the American Association of Cereal Chemists and Dietary Reference Intakes Report of the Institute of Medicine of the National Academies). The amount of dietary fiber in a product affects the glycemic response. However, there are questions about labeling them as such since only about 15% of them are quantitated by the early Official Methods of Analysis (AOAC 985.29 or AOAC 991.43) for the determination of dietary fiber.

INDEPENDENT OPINIONS ON
AGAVE IN DIABETICS


According to Dr. Susan Mitchell, PhD., RD, FADA, a licensed nutritionist and registered dietician, Fellow of the American Dietetic Association, and instructor in Nutrition and Health at the University of Central Florida for over eight years:

“If you are diabetic, your blood glucose may or may not be spiked…all depending on how much fructose is in the particular agave product consumed and your particular case of diabetes. Plus fructose sweeteners may increase blood triglycerides if you have diabetes so be sure and discuss this with your health care provider.”

“Is agave better for you than any other sweetener such as sugar, maple syrup or honey?

Agave is promoted as a low glycemic alterative for diabetics. Is it?

If you’re diabetic or have friends or family members who are, you don’t want to miss this.

Here’s why. Agave and sugar have approximately the same number of calories….about 16 per teaspoon. Agave is sweeter than sugar so you could save a few calories by the amount you use. Sugar is technically called sucrose which is composed of 50% fructose and 50% glucose when it is broken down in the body.

Agave varies in its fructose content with a range from 55% up to 90%. It all depends on the processing method used which can affect the fructose content. Agave nectar with 55% fructose is about the same as high fructose corn syrup so there would be no benefit in agave at 55% fructose over sugar, high fructose corn syrup or honey from the standpoint of composition, only taste and personal preference.

The reason you hear …theoretically… agave nectar touted as safer for diabetics is that a higher fructose composition typically doesn’t cause dangerous spikes in blood glucose.

Currently, we don’t have clinical studies as to agave’s safety in diabetes.

Unless there is a label stating the exact percentage of fructose in the agave nectar, it can range as we just talked about from 55% up”


April 8, 2009
Sweetener Update: Agave and Stevia

IN CONCLUSION


GRI is dedicating significant time and resources to determine if the reaction in diabetics occurs in generic Agave products as a result of ingesting high levels of Agave, or is related to other causes factors, such as stated in items 1-4.

Prior GRI clinical trials in diabetics using smaller doses of Agave did not instigate side effects, but the dosage levels used in the recent clinical trials were much higher than the previous trials.

The company that submitted the Volcanic Nectar brand Agave product, Global Goods Inc. of Highland, Utah, has been in direct contact with the Glycemic Research Institute (GRI) regarding this issue. Brian Oaks, President of Global Goods expressed his sincere determination to continue to provide safe and efficacious Agave products to the public, and is willing to take any necessary actions to prevent any negative reactions to their products.

Brian Oaks stated that the specific product submitted to GRI (Volcanic Nectar Agave Maple Syrup) was never sold to the public, and his intent was to have GRI conduct Human In Vivo Clinical Trials on the product prior to releasing it to the public.

In the interim, GRI has stated that they have instructed Brian Oaks to remove all Diabetic-Friendly statements and Certification Marks from their websites and marketing material until the issue has been resolved.

MEDIA & MEDICAL INQUIRIES

Medical and/or media-related questions may be addressed to the Glycemic Research Institute, Human in Vivo Clinical Trials Facility at (727) 894-6900 or via e mail from the Official Glycemic Research Institute® website at www.Glycemic.com




Copyright© October 2009
www.Glycemic.com
www.GlycemicResearchLaboratories.com

No copies of this article may be made without prior express written permission from the Glycemic Research Institute®




 
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