Abstracts of Evaluation Studies of Flanagan Enhanced Silica Hydride®
A Functional Silicate Nanocolloid
Clinton H. Howard and Kimberly Lloyd
Revised January, 2000
Royal BodyCare is conducting an ongoing series of laboratory and clinical studies designed to evaluate the nutritional characteristics and benefits of Flanagan Enhanced Silica Hydride (250 mg per capsule) as a mineral antioxidant. The following is a brief summary of the results of studies completed as of January 2000.
Flanagan Enhanced Silica Hydride® Effectively Lowered Blood Lactic Acid Levels During Strenuous Exercise
The Exercise Physiology Department of the University of North Texas Health Science Center at Fort Worth, Texas conducted a double blind, placebo controlled crossover study in 6 male cyclists for blood lactic acid (lactate) clearance during a 40K (24.8 mi) timed bicycle ride at maximum speed. Subjects received 4 capsules of Flanagan Enhanced Silica Hydride or placebo daily taking one in the morning, two at noon and one in the evening during the week prior to testing and during the week of testing. Subjects refrained from all other non-prescribed supplements during the testing period. Additionally, subjects took 2 capsules with water 30 min. before the start of exercise. Blood lactate levels was measured before and 5 min. after each exercise session. Flanagan Enhanced Silica Hydride significantly decreased blood lactic acid (lactate) levels as compared to placebo during strenuous exercise (p = 0.03). (Unpublished data Peter Raven Ph.D. 1999 & Wendy Wasmund, B.S. University of North Texas Health Science Center at Fort Worth, 1999.)
Lactic acid accumulates during strenuous or prolonged exercise. It is a common problem for athletes, people who work out, play sports or do physical exercise for an extended time.
The decreased lactic acid (lactate) levels immediately after strenuous exercise is another indicator of the ability of Flanagan Enhanced Silica Hydride to help in providing a direct energy source (ATP production) to cellular function. An ergogenic energy function is when a substance enhances biochemical energy without introducing additional carbohydrates or calories to the diet. Flanagan Enhanced Silica Hydride in Intra and Extra Cellular Hydration.
A double blind placebo controlled pilot study was conducted using the RJL Bioelectrical Impedance Analyzer that measures hydration of the body based on nutritional status developed by R. J. Liedtke. Seven subjects received 4 capsules of Flanagan Enhanced Silica Hydride per day for two weeks and were crossed over receiving 4 capsules per day of a placebo (rice bran flour). Averaged values showed increased intracellular and extracellular hydration due to the consumption of Flanagan Enhanced Silica Hydride as compared to the placebo group.
When consuming Flanagan Enhanced Silica Hydride, the value for Total Body Water (intracellular and extracellular water) increased by 2.7%. The changes observed in TBW when subjects consumed Flanagan Enhanced Silica Hydride, compared to the placebo, showed statistical significance (p < 0.05) using a student’s test for small sample groups.
Intracellular Water, the most sensitive indicator of nutrition and metabolic state, increased by 2.7%. Body Cell Mass (intracellular volume), another indicator of water within cells, also showed a 2% increase during supplementation with Flanagan Enhanced Silica Hydride.
The increase observed in Extracellular Water values were statistically significant (p < 0.05) when consuming Flanagan Enhanced Silica Hydride as compared to taking the placebo. (Unpublished data Gary Osborn R.Ph. & Heriberto Salinas, MD Texas Institute of Functional Medicines, 1999)
Body Cell Mass (BCM) and Intracellular Water (ICW) are assessments of intracellular volume and water inside the cell, respectively. Extracellular Body Water, water that bathes the cells, also showed increased volume. Intracellular water makes up approximately 60% of the total body water of healthy adults. Intracellular water, as an indicator of cell integrity, is found to be higher in babies but decreases as adults age or lose body cell mass. Healthy tissue cells hold water within the cells and have higher anabolic (building up) function rather than catabolic (breaking down) function.
Flanagan Enhanced Silica Hydride Protection Against Oxidative Stress
A double blind placebo controlled crossover pilot study was conducted on 7 subjects who received 4 capsules/day of Flanagan Enhanced Silica Hydride for two weeks, and received 4 capsules/day of a placebo for two weeks. Urine alkenal/creatinine ratios were measured. During Flanagan Enhanced Silica Hydride supplementation, a 43% increase in free radical protection was observed as compared to the placebo group. Flanagan Enhanced Silica Hydride was observed in this study to protect against serum alkenals. Alkenals are the oxidative products of serum lipid peroxides occurring from free radical attacks on cellular lipid membranes and lipoproteins. They are indicators of free radical damage in the body associated with a higher risk of age related diseases. (Unpublished data Gary Osborn R.Ph. & Heriberto Salinas, MD Texas Institute of Functional Medicines, 1999)
Evaluation of Flanagan Enhanced Silica Hydride in the Production of NADH in Vitro
ATP production, the principal source of energy in the mitochondria, depends on the production of NADH. Reduced hydrogen, generated by the Kreb’s Cycle, is carried by NADH into the mitochondria for the electron transport chain reactions that will ultimately create a molecule of water and ATP.
Hydrogen is one of the most important elements donating an electron, an electron pair or its proton to reduction/oxidation reactions of numerous enzymes and intermediates within the cell’s metabolic pathways. In vitro assays measured the direct conversion of NAD+ to NADH by the addition of Flanagan Enhanced Silica Hydride. The sequential addition of increasing concentrations of Flanagan Enhanced Silica Hydride to NAD+ showed a linear increase in NADH production as measured by its absorption at 350 nm. (Unpublished data Joe McCord, Ph.D University of Colorado Health Sciences Center, 1998).
Flanagan Enhanced Silica Hydride Increases Mitochondrial NADH Production and Enhances Mitochondrial Membrane Potential in Intact Liver Cells
Flanagan Enhanced Silica Hydride (200 ug/ml) was introduced to cultured 90% viable rat hepatocytes (500,000cells/ 4ml medium). Blue autofluorescence of mitochondrial NADH was visualized by a Zeiss LSM 410 inverted laser scanning confocal microscope using a 40X water immersion lens and 356/365 nm excitation light from a UV argon laser. Under the conditions used, autofluorescence arises primarily from mitochondrial NADH. Oxidation of NADH to NAD causes loss of fluorescence since only NADH is fluorescent.
The line graph summarizes data from 3 Flanagan Enhanced Silica Hydride and 3 vehicle (control) experiments. In the Flanagan Enhanced Silica Hydride group NADH increased 20% over 20 minutes while the vehicle group showed a decrease in NADH fluorescence by about 30%. These preliminary experiments suggest that Flanagan Enhanced Silica Hydride promotes electron transfer to NAD in intact living hepatocytes. Moreover, Flanagan Enhanced Silica Hydride prevented the spontaneous oxidation (or bleaching) of NADH that generally occurs during an incubation of this type (see vehicle plot) thereby indicating a continuous recharging of the pyridine nucleotide (NADH).
Mitochondrial membrane potential was monitored using overnight cultured hepatocytes similar to the NADH experiment and which were loaded for 20 min. with the fluorescent probe tetramethylrhodamine methylester (TMRM). The medium was adjusted to pH 7.4 to assure that the previously noticed increase in membrane potential was not due to a pH effect. The TMRM-loaded cells were imaged with a Zeiss 410 inverted laser scanning confocal microscope through a 63X objective lens. In these experiments, an increase of the mitochondrial fluorescence of TMRM represents an increase of mitochondrial depolarization (more negative membrane potential). The line graph summarizes data from 3 Flanagan Enhanced Silica Hydride and 4 vehicle experiments. In the vehicle group, TMRM fluorescence decreased by about 6% over 20 minutes. In the Flanagan Enhanced Silica Hydride group, TMRM increased about 25%. These preliminary experiments suggest that Flanagan Enhanced Silica Hydride enhances mitochondrial membrane potential in intact living hepatocytes. The combination of increased mitochondrial membrane potential and increased NADH suggests an enhancement of bioenergetic capacity of the mitochondria when Flanagan Enhanced Silica Hydride is present in the cell suspension (Unpublished data 1999). Flanagan Enhanced Silica Hydride appears to be providing electrons or H- available to the cofactors that are able to utilize these for cellular energy production. NADH provides electrons to the mitochondria electron transport chain directly producing H20 and ATP, the primary cellular energy source for numerous biochemical reactions throughout the cell.
Evaluation of Flanagan Enhanced Silica Hydride as a Scavenger of Free Radicals, Report I
Tests on Flanagan Enhanced Silica Hydride were conducted using electron spin resonance techniques (ESR) by a scientist who specializes in the evaluation of antioxidants at a major university. The following is quoted from the test report:
“We have made a thorough investigation of the antioxidant activity of Flanagan Enhanced Silica Hydride by several experimental methods. Hydroxyl radical scavenging activity was found in two different Flanagan Enhanced Silica Hydride preparations provided.”
“Our conclusions are that Flanagan Enhanced Silica Hydride has antioxidant activity towards hydroxyl radicals. Hydroxyl radicals are among the most dangerous of oxygen free radicals that occur in biological systems. They are the same types of radicals that can be produced by exposure to ionizing radiation. Therefore, it can be stated that Flanagan Enhanced Silica Hydride has antioxidant activity in this regard.” (Personal Communication: Lester Packer, Ph.D., University of California at Berkley, 1999)
Evaluation of Flanagan Enhanced Silica Hydride as a Scavenger of Free Radicals, Report II
Tests on Flanagan Enhanced Silica Hydride were conducted by a scientist who specializes in the evaluation of antioxidants at a separate major university. The following is quoted from the test report: “When assayed in the ‘standard’ assay for super oxide dismutase activity based upon the reduction of cytochrome c by xanthine (see J. Biol. Chem. 244: 6049-6055, 1969), Flanagan Enhanced Silica Hydride showed two characteristics:
1. Flanagan Enhanced Silica Hydride can directly reduce cytochrome c, showing that it is a reducing agent (or an antioxidant).
2. Flanagan Enhanced Silica Hydride can inhibit the superoxide-mediated reduction of cytochrome c, indicating that it can scavenge the superoxide free radical.”
“When assayed with an alternative method based on the ability of superoxide to oxidize epinephrine to adrenochrome, Flanagan Enhanced Silica Hydride also showed its ability to scavenge the superoxide radical and inhibit the process.” (Personal Communication: Joe McCord, Ph.D., University of Colorado Health Sciences Center, 1998). An abstract of this in vitro antioxidant data was presented and published in the Proceedings of the National Hydrogen Association 10th Annual Meeting. pg. 595-610; 1999)
Physician Using Flanagan Enhanced Silica Hydride Climbs Mount Everest Without Oxygen
In 1991, at age 39, Denis Brown M.D. of British Columbia attempted to climb Mt. Everest without supplemental oxygen. He reached 26,000 feet. Again in 1994 he made the climb and achieved 28,000 feet before he surrendered to the extreme conditions and turned back. In 1999, at age 47, he added Flanagan Enhanced Silica Hydride to his supplement regime. Flanagan Enhanced Silica Hydride helps to reduce the build-up of free radicals and lactic acid, and supports production of ATP. He succeeded in reaching the peak of the South Summit at 28,750 ft. without supplemental oxygen and reported that this time he felt stronger and had more energy than on previous climbs.
Aging Marathon Runner On Flanagan Enhanced Silica Hydride Improves Time
In January 1997, at age 39, Andrey Kusnetzov ran the Brazil Marathon in 2 hr. 17 min. and 52 sec. The following December, he added Flanagan Enhanced Silica Hydride to his daily supplement regime, taking two capsules with a third capsule opened into his glass of water each morning and again each evening. In January, he ran 2 minutes faster, winning first place in the Masters Division (Age 40+) at the Houston Methodist Marathon. The following April 1998, he continued to improve his time and won the Boston Marathon Masters. One year later, at age 41, in a field of 12,000 runners, he again won the Boston Marathon Masters in a faster time of 2 hr. 14 min. and 20 sec., despite higher wind and heat which caused other top runners to finish with slower times than in the previous year. Following the race, RBC’s medical director entered the recovery room where exhausted runners collapsed on cots and were treated for fainting, hyperthermia, and vomiting. Andrey remained standing, relaxed, and appeared unaffected by the run.
Tests On The Functions of Flanagan Enhanced Silica Hydride
Flanagan Enhanced Silica Hydride is a mineral (silica, potassium, magnesium) formed into extremely small negatively charged colloids (nanocolloids) that have been saturated with hydrogen. The minerals have been found to be in the range of 1-5 microns in size when analyzed with Electron Scanning Micrographs. Its function is to provide literally trillions of hydrogen anions capable of donating electrons into body fluids. Electrons, which Albert Szent-Gyorgyi called the “fuel of life”, are abundantly available in organically grown raw vegetables, fruits, and grains, but are deficient in our modern diet of over-cooked, acidic, or highly oxidized foods, beverages, and drinking water. Tap water and bottled waters are oxidized, acidic, and do not provide a source of electrons. When consumed, the body must substantially alter their chemical characteristics in order to convert water into optimal extracellular and intracellular body fluids. Three such characteristics are conductivity, oxidation/reduction potential (ORP) and surface tension.
Conductivity is critical to the optimal function of body fluids. When conductivity was assessed, 250 mg of Flanagan Enhanced Silica Hydride in 8 oz of tap water increased from 10 to 895 µMhos/cm. Total dissolved solids also increased.
To measure the level of electrons available in Flanagan Enhanced Silica Hydride, a 250 mg capsule was dispersed into 8 oz of tap water and into each of twelve 8 oz glasses of different brands of bottled water. The results shown were measured before, and one hour after the addition of Flanagan Enhanced Silica Hydride:
Water Values With Flanagan Enhanced Silica Hydride
The ph and Oxidation Reduction Potential (ORP) were measured in various types of bottled and tap waters. Flanagan Enhanced Silica Hydride decreases the ORP and increses the ph of water.
This table shows a comparison of various types of antioxidant products. Products are single servings dissolved in 100 ml. of deionized water.
Biological Oxidation-Reduction Reactions
Metabolic oxidation-reduction reactions are extremely important to the cell. Oxidation-reduction reactions (ORP or redox) involve the loss of electrons by one chemical species, becoming oxidized, and the gain of electrons by another species, becoming reduced. The flow of electrons in redox reactions is responsible, directly or indirectly, for all of the work done by living organisms. The tendency of these reactions to occur depends upon the relative affinity of the electron acceptor for electrons. Electron flow is spontaneous and exergonic (releases energy) in the cell because oxygen, the final electron acceptor, has a higher affinity for electrons than do the intermediates that donate electrons.
ORP is a measure of oxidation-reduction potential with standard meters, such as the Electronmeter™, that measure negative ions in solution. The Nernst equation relates standard reduction potential (Eo) to potential (E) at any concentration of oxidized and reduced species in a system. Another value derived from the Nernst equation utilizing pH, measures relative hydrogen (rH2) and is used as a redox indicator for biological fluids as seen in the Biological Terrain Assessment study. Various types of water depending on mineral salt content and water treatments will show variability in ORP readings with standard meters. ORP measurements with Flanagan Enhanced Silica Hydride vary depending on water purity, dilution, the time it has remained in solution, proper cleaning of the meter probes and maintenance of the meter.
The surface tension of tap water is approximately 73 dynes. The surface tension of extracellular fluids is much lower at approximately 45 dynes. This low surface tension is critical to cellular function, absorption of nutrients, and to the removal of toxins. A 250 mg capsule of Flanagan Enhanced Silica Hydride dispersed into an 8 oz glass of tap water has been shown to reduce surface tension to approximately 45 dynes, the same surface tension of extracellular fluids.
Safety Studies With Flanagan Enhanced Silica Hydride:
Acute Oral Toxicity Study
Flanagan Enhanced Silica Hydride has been evaluated using standardized tests at a toxicology laboratory and was found to be a nontoxic substance. Flanagan Enhanced Silica Hydride (250 mg in rice bran flour) was administered, with corn oil as an oral carrier, to rats at a concentration of 5 gm/kg body weight. The LD50 was found to be greater than 5 gm/kg which meets the U..S. Food and Drug Administration’s limit tests and the European Regulatory Standards (2 gm/kg) for a nontoxic substance.
Pre-Clinical Trial With Human Subjects Taking Flanagan Enhanced Silica Hydride
A controlled clinical trial showed that in eight normal adult subjects, seven of the nine Biological Terrain Assessment parameters improved. Saliva pH, saliva rH2, blood resistivity, and urine resistivity showed statistically significant improvement (p < 0.05) for these eight subjects after 18 days of supplementation with 4 Flanagan Enhanced Silica Hydride per day on a schedule of one in the morning, two at midday and one in the evening. Three other parameters (urine pH, urine rH2, and saliva resistivity) also showed improvement over the 18-day supplementation period when their averaged changes were calculated.
Presented at the American College of Nutrition Symposium on Advances in Clinical Nutrition. Albuquerque, New Mexico, October, 1998.
These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent disease.