Protocols & Quantification of
Diagnostic & Analytical Parameters for
"Certified Natural Beverage"




Protocols


There are three separate protocols involved in analyzing and identifying products that fit the criteria for “Certified Natural Beverages”.

1.
Identification of ingredients deemed not to be “Natural”
2.
Laboratory Analysis of Products Submitted
3.
Low Glycemic Human In-Vivo clinical trials


Factor Number 1:
Natural Ingredients Criteria

The following ingredients are NOT considered "NATURAL"and are exempted from being included in a Certified Natural Beverage


High Fructose Corn Syrup

The Food & Drug Administration has recently ruled that beverages which contain HIGH FRUCTOSE CORN SYRUP may not be labeled as “Natural.”

Therefore, beverages that contain HIGH FRUCTOSE CORN SYRUP do not qualify for the “Certified Natural Beverage” mark.



Synthetic & Chemical Sweeteners

Beverages that contain synthetic and/or chemical sweeteners do not qualify for the “Certified Natural Beverage” mark. These include:

• acesulfame potassium (ACE-K)

• aspartame

• cyclamates

• neotame

• saccharin

• sucralose



Sugar Alcohols

Sugar alcohols (technically called polyols) are carbohydrates that are neither sugars nor alcohols.

Beverages that contain sugar alcohols do not qualify for the “Certified Natural Beverage” mark. These include:

xylitol

mannitol

sorbitol

isomalt

maltitol

maltitol syrup

lactitol erythritol

In diabetics, the glycemic response to sugar alcohols can be profound. Sorbitol has been known to elevate blood sugar slower than high glycemic sugars, but rapidly enough to cause postprandial blood sugar elevation. Significant blood sugar elevation is evidenced hours after consuming foods containing sugar alcohols and/or sugar alcohol syrups.

Isomalt, a sugar alcohol, has been shown to cause moderate to profound gastric distress, including diarrhea and flatulence. In children age 4 to 14, isomalt was shown to cause diarrhea in 25 % of the children.

http://inchem.org/documents/jecfa/jecmono/v20je14.htm

Health potential of polyols as sugar replacers, with emphasis on low glycemic properties; Nutrition Research Reviews 2003;16:163-91.

British Journal of Nutrition. 2005 Nov;94(5):643-6.Human gut microbiota does not ferment erythritol.

Use of a new sugar substitute, erithritol, in the diet therapy of type 2 diabetes patients. Voprosy Pitaniia. 2002;71(3):19-23.


Diabetes Spectrum Volume 17, Number 3, 2004. Low Carbohydrate Food Facts and Fallacies. Freeman et al



Toxic Glycosides

Beverages that contain toxic glycosides, such as Licorice do not qualify for the “Certified Natural Beverage” mark. Licorice glycosides have been shown to cause spontaneous abortion in the first trimester of pregnancy. Per the FDA Code of Federal Regulations 21, parts 170 to 199, Revised as of April 1, 2000, 184.1408, Licorice and Licorice derivatives (glycyrrhiza) are not permitted to be used as a nonnutritive sweetener in sugar substitutes.


Ingredients that Exacerbate
Type 2 Diabetes

Type 2 Diabetes is a disease that is totally preventable given acceptable preventive measures, such as diet and exercise. Beverages that contain ingredients that have been clinically proven to exacerbate Type 2 Diabetes include honey, molasses, maple syrup, rice syrup, white grape juice, sucrose, and glucose polymers. Beverages that contain these ingredients do not qualify for the “Certified Natural Beverage” mark.


T-Acetylcysteine

T-Acetylcysteine is an antioxidant commonly used in dietary supplements that can lead to pulmonary arterial hypertension, according to research from the University of Virginia (UV) Health System. The study examined the effect of N-acetylcysteine (NAC) and the results, published in the Journal of Clinical Investigation, indicate the antioxidant can form a red blood cell-derived molecule that makes blood vessels think they are not getting enough oxygen. This can lead to pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries carrying blood to the lungs. According to the researchers, "NAC fools the body into thinking that it has an oxygen shortage - We found that an NAC product formed by red blood cells, know as a nitrosothiol, bypasses the normal regulation of oxygen sensing. It tells the arteries in the lung to 'remodel'; they become narrow, increasing the blood pressure in the lungs and causing the right side of the heart to swell." Beverages that contain T-Acetylcysteine do not qualify for the “Certified Natural Beverage” mark.


Modified and Refined Soy

Independent scientific evidence has clearly demonstrated the dangers of ingesting modified or refined soy products in women.


Increased Risk of Breast Cancer by
Refined Soy Products:

Phytoestrogens
Dr. William Helferich
Professor
Department of Food Science and Human Nutrition
University of Illinois

Dietary phytoestrogens & Breast Cancer: a complex safety issue involving dose & timing of exposure

Genistein, found in soy products, is a phytochemical with estrogenic activity. Our research has focused on the effects dietary genistein on growth of estrogen (E)-dependent mammary tumors both in vitro and in vivo. Genistein enhances the proliferation of E-dependent human breast cancer tumor growth.

We have demonstrated that soy protein isolates processed to contain low, medium, and high amounts of isoflavones simulate tumor growth in a dose-dependent manner. Expression of the estrogen-responsive gene pS2 was also induced in response to treatment with dietary genistein. We also evaluated the effect of dietary genistein in the chemically induced (NMU) mammary cancer rodent model and have demonstrated that dietary genistein stimulates growth in this model. To evaluate whether dietary genistein interacts with current anti-estrogen breast cancer therapy such as tamoxifen (TAM), we implanted E-dependent tumors into ovariectomized athymic mice and administered estradiol, estradiol plus TAM, or estradiol, TAM plus dietary genistein. In these studies dietary genistein was able to negate the inhibitory effect of TAM on E-stimulated tumor growth. Genistein is present in soy as part of a complex mixture and the profile of these other bioactive compounds plays an important role; we will present data on how the profile of soy bioactive compounds can modulate genistein-stimulated, estrogen-dependent tumor growth. In summary, genistein can act as an estrogen agonist resulting in proliferation of Edependent human breast cancer cells in vivo and can negate the inhibitory effects of TAM on E-stimulated growth of MCF-7 cell tumors (in vivo).

Soy, breast cancer prevention link questioned

4/5/2006

Review: The review examined 18 studies conducted over 26 years, and were published in the Journal of the National Cancer Institute.

"Because soy foods and soy supplements are widely used, we conducted this first true meta-analysis to understand what role soy foods might have on breast cancer risk," said scientists at Georgetown University Medical Center and Johns Hopkins School of Medicine.

The new findings prompted the scientists to warn that high dose soy supplements, taken by women to reduce their risk of developing breast cancer, could do more harm than good. Short-term studies of women taking such supplements showed changes in breast cell growth that might actually increase risk for breast cancer, while tests of refined soy products in animals revealed increased tumor growth. However, on the up side, the scientists said that there is no risk when it comes to adding soy to the diet. “The important aspect is eating actual soy-based foods like tofu, not highly purified isoflavone supplements. Highly refined components of soy can have very different biological effects than eating tofu or drinking soymilk,” said Dr Bruce Trock, associate professor of urology, epidemiology and oncology at John Hopkins.

Beverages that contain Soy isolfavones and/or modified or refined soy, do not qualify for the “Certified Natural Beverage” mark.



Taurine

Ingredient in Energy Drinks Deemed Dangerous
Taurine: Culprit in Heart Function & Blood Pressure
Are Energy Drinks Safe for the Heart?


The AMERICAN HEART ASSOCIATION (AHA) recently announced that energy drinks can dangerously affect heart function and blood pressure. This announcement was made at the American Heart Association’s Scientific Sessions and came as quite a surprise to researchers. The AHA report was based on clinical studies that demonstrated “Blood pressure and heart rate levels increased in healthy adults who drank two cans a day of a popular energy drink containing Taurine and caffeine.”

Clinical trials involving energy drinks have shown that caffeine/Taurine beverages can be dangerous to patients with heart disease, and that drinking more than two cans a day can lead to higher risk increases, even in healthy people (1). The researchers advised people with high blood pressure and heart rate to "avoid these drinks". The dangerous cocktail of Taurine and caffeine was proven to cause pressure-induced bradycardia which induced changes in heart rate and mean arterial blood pressure.

In double-blind placebo trials, the strictest and most accurate form of clinical trials, Red Bull was proven to cause “significant decline in heart rate and an increase in mean arterial blood pressure (2).” Red Bull contains Taurine.


Energy Drinks Jolt Blood Pressure

MEDSCAPE, Diabetes & Endocrinology; Energy Drinks Jolt Blood Pressure (3), reported that energy drinks containing caffeine and the amino acid Taurine, “can adversely affect heart function and blood pressure.”

The results prompted researchers to advise people with hypertension or heart disease to avoid energy drinks containing caffeine and Taurine, as they could impact the effectiveness of medication, as well as their blood pressure. Top Neurologists have additionally confirmed that the combination of caffeine and Taurine could cause seizures in humans. Researchers stated that large consumption of energy drinks that contain both caffeine and Taurine can provoke seizures (4). The Neurologists reported that “Once the patients were abstinent from the energy drinks, no recurrent seizures were reported.”

Beverages that contain Taurine do not qualify for the “Certified Natural Beverage” mark.

Beverages that contain high levels of caffeine (more than 150 mg/serving) do not qualify for the “Certified Natural Beverage” mark.



Bovine Colostrum

Bovine Colostrum (Misoprostol): Misoprostol acid in colostrum causes spontaneous abortion. Bovine Colostrum can cause spontaneous abortion in young women due to its misoprostol content. Bovine Colostrum is contraindicated in young women because of its pro-abortive and teratogenic activity, which causes stimulate uterine contractions, vaginal bleeding and miscarriage. Beverages that contain Bovine Colostrum do not qualify for the “Certified Natural Beverage” mark.


Growth Hormone

Beverages that contain Growth Hormone (GH) and/or Bovine GH do not qualify for the “Certified Natural Beverage” mark. GH has been shown to cause severe side effects in humans including bone deformities. Beverages that contain Growth Hormone do not qualify for the “Certified Natural Beverage” mark.


Dangerous Forms of L-Arginine

Per the Johns Hopkins University Human Clinical Trials on L-Arginine, and the Journal of the American Medical Association (JAMA) report on L-Arginine, some forms of the amino acid can cause mortality.


Arginine HCL

In studies where the HCL form of L-arginine has been used, metabolic acidosis and alterations in electrolytes have been documented. It is therefore not recommended for human use. Arginine HCL is the form that was used in the tragic Johns Hopkins/JAMA clinical trial that caused mortalities.

Arginine Pyroglutamate
Not recommended for human use. Mechanism of action in the body is entirely speculative according to the Physician’s Desk Reference (PDR).

Arginine Ketoglutarate And Alpha-Ketoglutarate (AKG)
Researchers and physicians caution that Alpha-ketoglutarate is not recommended for human use.

Beverages that contain the toxic forms of L-Arginine do not qualify for the “Certified Natural Beverage” mark.



Dangerous Herbs

Aristolochic acid is judged to be "definitely hazardous" because of documented kidney failure (sometimes requiring transplant), deaths, and known potent cancer-causing properties. Ephedra, Ma Huang, Comfrey, herbal androstenedione, chaparral, germander, and kava are classified as "very likely hazardous" because they are banned in other countries; have generated an FDA warning; or are identified as causing adverse effects in studies. Each is known by more than one name. Abnormal liver function or damage, often irreversible, and deaths have been reported for chaparral, comfrey, germander, and kava. Bitter orange, organ/glandular extracts (brain/adrenal/ pituitary/placenta/other gland "substance" or "concentrate"), lobelia, pennyroyal oil, skullcap, and yohimbe are considered "likely hazardous." This category applies to ingredients for which there have been adverse-event reports or because of theoretical risks.

Beverages that contain any of these herbs do not qualify for the “Certified Natural Beverage” mark.



St. John's Wort

St. John's Wort is not allowed in a beverage at any level

The botanical, St. John’s Wort is not allowed, by the FDA, for use as an ingredient in a beverage. St. John’s Wort is not a GRAS substance or an approved food additive, per FDA guidelines, and may not be used in beverages of any type.



Carmine

Carmine is a red coloring frequently used in yogurt, candies, fruit drinks and sweets. Carmine is made from deceased ground-up husks of female red beetles. The beetles, which originate from the Canary Islands, are dried and ground up to create a red paste. The red paste is then exported to the United States and other countries where food is produced, and foods to give them a strawberry-like color. Carmine is listed on labels as "carmine", and not as "ground-up red beetles." While carmine may not pose a health risk to American consumers, it is an example of questionable labeling, as consumers have the right to know when ground-up insects are being used in their foods.

There are approximately 100 items in the grocery store with carmine listed on the label (such as many strawberry yogurt products). Beverages that contain Carmine do not qualify for the “Certified Natural Beverage” mark.


Sodium Nitrite

Sodium Nitrite, when combined with saliva and digestive enzymes, creates cancer-causing compounds known as nitrosamines. In humans, consumption of Sodium Nitrite (SN) is correlated with cancer, leukemia, and brain tumors. SN does not require a warning on food labels.

Beverages that contain Sodium Nitrite do not qualify for the “Certified Natural Beverage” mark.



Factor Number 2:
Laboratory Analysis

The Protocol for utilization of the Natural Beverage Certification requires submission of the beverage product for independent laboratory analysis. Methods of Testing are outlined below:


Macronutrients

Ash
Gravimetric Determination
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 923.03. (Modified)

Calories
By calculation
United States Department of Agriculture, "Composition of Foods," Agricultural Handbook, No. 8, pp. 159-160, (1982)
Calorimeter (Bomb calorimetry)
Oxygen Bomb Calorimetry and Combustion Methods, Manual No. 160, Parr Instrument, Moline, IL, 1981. (Modified)

Carbohydrates (total)
By calculation
Composition of Foods, Agriculture Handbook No. 8, United States Department of Agriculture, pp. 164-165, 1975

Fat
Acid hydrolysis

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Methods 922.06, 954.02. (Modified)

Enzymatic Hydrolization (methanol/chloroform)


Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 983.23. (Modified)

Hydrolization (Roese-Gottlieb Method)

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Methods 905.05, 920.11, 932.06. (Modified)

Soxhlet Extraction

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 960.39. (Modified)

Moisture
Vacuum oven
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Methods 925.09, 926.08. (Modified)

Autotitration (Karl Fischer method)
The United States Phamacopeia, Twenty-Fifth Revision, United States Pharmacopeial Convention, Inc.: Rockville, Maryland (2002)

Protein
Protein Analyzer (Dumas Method)

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 968.06. (Modified)

Titration (Kjeldahl Method)

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Methods 955.04, 979.09. (Modified)

Bradstreet, R. B., The Kjeldahl Method for Organic Nitrogen, Academic Press, New York, New York (1965). (Modified)

Kalthoff, I. M., and Sandell, E. B., Quantitative Inorganic Analysis, MacMillan, New York (1948). (Modified)

Proximate package (moisture, ash, protein, and fat)
Gravimetric

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Methods 925.09, 926.08. (Modified)

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 923.03. (Modified)

Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 968.06. (Modified)

Official Methods of Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Methods 922.06 and 954.02. (Modified)

Specific gravity
Calculation
The United States Phamacopeia, Twenty-Fifth Revision, United States Pharmacopeial Convention, Inc.: Rockville, Maryland (2002)



Raw Ingredients

Soy (isoflavones)
Gas chromatography
Seo, A. and Morr, C.V., "Improved High-Performance Liquid Chromatographic Analysis of Phenolic Acids and Isoflavonoids from Soybean Protein Products," J. Agric. Food Chem., 32(3): pp 530-533, 1984

Ephedra or Ma Huang (Ephedra alkaloids)
High performance liquid chromatography
Planta Medica 1988 pp. 69-70 (modified)

Guarana (caffeine)
Gas chromatography
Journal of Food Science (modified), 48: 745-747, (1983)


Isflavones (soy, kudzu, clover)
Gas chromatography
Seo, A. and Morr, C.V., "Improved High-Performance Liquid Chromatographic Analysis of Phenolic Acids and Isoflavonoids from Soybean Protein Products," J. Agric. Food Chem., 32(3): pp 530-533, 1984

Kudzu (isoflavones)
High performance liquid chromatography
Seo, A. and Morr, C.V., "Improved High-Performance Liquid Chromatographic Analysis of Phenolic Acids and Isoflavonoids from Soybean Protein Products," J. Agric. Food Chem., 32(3): pp 530-533, 1984

Anthocyannin (bilberry, grape seed)
High performance liquid chromatography

Clover (isoflavones)
High performance liquid chromatography
Seo, A. and Morr, C.V., "Improved High-Performance Liquid Chromatographic Analysis of Phenolic Acids and Isoflavonoids from Soybean Protein Products," J. Agric. Food Chem., 32(3): pp 530-533, 1984

Dong Quai (ferulic acid)
High performance liquid chromatography
Hagerman, A.E., Nicholson, R.L., "High-Performance Liquid Chromatographic Determination of Hydroxycinnamic Acids in Maize Mesocotyl," Journal of Agricultural and Food Chemistry, 30 (No. 6): 1098-1102, (1982), Modified

Echinacea (cichoric and chlorogenic acid)
High performance liquid chromatography
Economic and Medicinal Plant Research, Vol. 5, H. Wagner and Norman Farnsworth Ed., Academic Press, 1991, p.253-321

Evening Primrose Oil (linoleic acid & GLA)
Gas chromatography
American Oil Chemists' Society, 'Ce 1-62 Fatty Acid Composition by Gas Chromatography' (modified), Official Methods and Recommended Practices f the AOCS, Fifth Ed., American Oil Chemists' Society, Champaign, IL (1997)

Feverfew (parthenolide)
High performance liquid chromatography


Ginkgo Bilob

  Ginkgoflavone glycosides
High performance liquid chromatography
Journal of Chromatography (modified), 605: 41-48 (1992)
  Ginkgo terpenoids
High performance liquid chromatography
Journal of Chromatographic Science (modified), 36: April (1998)

Ginseng, (ginsenosides)
Panax or Korean
High performance liquid chromatography
Journal of Chromatography, 736 (1996) 77-81
Siberian
High performance liquid chromatography
Chem. nat. compd. (English translation) vol. 28, no. 1, July 1992, pp. 36-39

Grapes/Raisins (tartaric acid) HPLC
High performance liquid chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 986.13. (Modified)

Green Tea (phenols & caffeine)
UV detection

Nettle Root (phytosterols)
Gas chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 994.10. (Modified)

Pygeum (beta-sitosterol)
Gas chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 994.10. (Modified)

Saw Palmetto (phytosterols & fatty acids)
Gas chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 996.06. (Modified)


Valerian (valerenic acid)
High performance liquid chromatography
Journal of Liquid Chromatography, 10: 643-653, (1987). (Modified)

St. John's Wort (hypericin, pseudohypericin)
High performance liquid chromatography
High-Performance Liquid Chromatographic Determination of the Biologically Principle Hypericin in Phytotherapeutic Vegetable Extracts and Alcoholic Beverages," Journal of Chromatography A, 731: 336-339, 1996



Amino Acids

Free amino acid profile
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 982.30. (Modified)

Taurine
Hischenhuber, C., Deutsche Lebensmittel-Rundschau , "High Performance Liquid Chromatographic and Thin-Layer Chromatogrphic Determination of Taurine in Infant Formulas", /84, JAHRG. /HEFT 4/1988. (Modified)
Stuart, J.D., Wilson, T.D., Hill, D.W., Walters, F.H., Feng, S.Y., "High Performance Liquid Chromatographic Separation and Fluorescent Measurement of Taurine, a Key Amino Acid", Journal of Liquid Chromatography, 2(6), 809-821 (1979)

Individual amino acids (free-form)
Amino acid analyzer
Official Methods of Analysis of AOAC INTERNATIONAL (2002), 17th Edition, AOAC INTERNATIONAL, Gaithersburg, MD, USA Official Method 982.30 (Modified)

Individual amino acids (requiring hydrolysis)
Amino acid analyzer
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 982.30. (Modified)

Methionine and cystine (performic acid hydrolysis)
Amino acid analyzer
Official Methods of Analysis of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 982.30. (Modified)




 
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