Pierre @ Ecohealth Carbohydrate -Derived Fulvic Acid.

What is Carbohydrate-Derived Fulvic Acid

Carbohydrate-Derived Fulvic Acid (CHD-FA™) is an internationally-patented, safe, non-toxic, water-soluble and heat-stable active ingredient for use in food, health supplements and medicines. It is a new, pure and uniform version of an ancient ingredient from nature – environmental fulvic acid.

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 Ask yourself why people take mud baths? It is because of the healing properties of the humic and fulvic acids in the mud. It is often called ‘Nature’s Miracle Molecule’. It is found in soil and nothing on this planet can grow without it. It is the energy of life. Its medicinal properties are well-known and have been documented over thousands of years.

Environmental fulvic acid is formed over a very long period of time in extremely small amounts by millions of beneficial microbes that work on decaying plant matter. Fulvic acid then works to activate the nutrients within soil so that they can be utilised by the cells of plants.

FulvicTextLike its action in soil, fulvic acid serves as an essential vehicle that carries vitamins and nutrients to the right place in our bodies. Rather than a single molecule, it is a range of organic acids, each one having its own action and purpose and the whole working together.

The patented CHD-FA™ is a unique supramolecular fulvic acid – it has a fixed structure with a range of backbone structures (consistent from batch to batch) working in your body as intended by nature.

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Because of CHD-FA™ being a range of organic plant acids it has a wide range of efficacy. It is a proven anti-inflammatory, antiviral, antimicrobial, antifungal and antioxidant agent whilst assisting with nutritional uptake. The unique invention of CHD-FA™ is to simulate what takes place over many years in nature – in essence fast-tracking the natural process.

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You may ask yourself why only now? Why has fulvic acid not previously been used extensively for healing and better health? The reason for this is evident in the table below:

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Carbohydrate-Derived Fulvic Acid (CHD-FA™)                                                          Environmental Fulvic Acids                                    
Free of heavy metals Contains heavy metals
Free of contaminants Risk of contaminants
Batch to batch consistency proven Batches vary
GMP and FSSC 22000 approved Not GMP approved
Own safety work successfully completed Minimal, if any, safety work
Own efficacy proven in vitro and in vivo                                                                                                    Efficacy relies on anecdotal data and general literature

Carbohydrate-Derived Fulvic (CHD-FA™) has had its OWN safety as well as efficacy work completed at various institutions worldwide. It is produced close to Stellenbosch in a cGMP (License No. 0000001280) and Manufacturing Pharmacy (License No. FY54509) which is also a FSSC 22000-approved facility, making it the ONLY fulvic acid being produced under such strict regulatory conditions and having its own scientifically proven safety as well as efficacy record.

Health and Wellness Benefits

CHD-FA™, being a range of organic acids, has a wide array of healing properties each having its own effect on human health. It is a proven anti-inflammatory, antiviral, anti-microbial, antifungal and antioxidant agent whilst assisting with nutritional uptake.

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General health benefits when taking CHD-FA™ are the following:

  • Helps improve nutritional uptake. Studies have shown that CHD-FA™ increases the uptake of minerals by up to 60% more than normal, supporting good health.
  • CHD-FA™ is a proven chelator making ions more available to the body which is crucial for energy in cells.
  • CHD-FA™ is one of the most effective antioxidants eliminating free radicals, limiting their damage to the membranes of cells, proteins and DNA.
  • CHD-FA™ also assists with gut health because of its properties.
  • Because of the mineral and trace elements in CHD-FA™ it is an excellent natural electrolyte that is able to replace essential micro-elements lost when sweating.
  • The various clinical properties of CHD-FA™ assist in building the immune system.
  • CHD-FA™ with its antioxidant, enhanced nutritional uptake and anti-inflammatory properties helps with chronic fatigue.

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Over and above the attributes mentioned above, CHD-FA™ has the following specific health benefits as has been proven by work done on CHD-FA™:

  • CHD-FA™ is an anti-inflammatory
  • CHD-FA™ is antibacterial and antimicrobial
  • CHD-FA™ is antifungal
  • CHD-FA™ is antiviral

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What benefits can you expect when taking CHD-FA™?

Because of all the properties mentioned above, you can expect the following when you regularly drink CHD-FA™:

  • A stronger immune system which gives you better protection against diseases and infections.
  • Better balanced blood sugar.
  • Renewed energy.
  • Reduced inflammation and free radical damage.
  • Shortened recovery time from muscular and joint pains.
  • Better oxygenation.
  • Cleansing of your body.
  • Lessening of health risks associated with heavy metals.
  • Assists with improved concentration.
  • Assists with increased metabolism.
  • Helps reduce recovery time after exercise.
  • When used topically it kills bacteria, preventing or clearing up infections.

CHD-FA™ and Sport

 The various properties of CHD-FA™ have been described under the Benefits section. It is these benefits which make it so useful to people participating in any type of sport because if fulvic acid is taken regularly over a period of 2–3 months, problems associated with lactic acid and carbon dioxide may be reduced.

 

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CHD-FA™ as a free radical scavenger, antioxidant and anti-inflammatory has the ability to protect muscle cells and thus may reduce the detrimental effects of lactic acid build-up and inflammation. Testimonials have shown that when CHD-FA™ sport supplements are taken, muscle soreness after exercise is decreased and an ability to train for longer is noticed.

Testimonials have shown that when CHD-FA™ supplements are taken for a sufficient time, muscle soreness after exercise is decreased and the ability to train for longer is noticed.

It is vital, especially for athletes, to consume a regular amount of anti-oxidants. Well-known anti-oxidants include vitamins A, C and E, but the complex structure of CHD-FA™ makes it far more powerful an antioxidant than any other nutrient known. This, combined with its anti-inflammatory and chelating properties, make it an ideal supplement to be used when doing sport.

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It is widely known that fulvic acid possesses truly remarkable biological properties. It is these properties which make the use of CHD-FA™ as a supplement for athletes a must because it:

  • Is an anti-inflammatory assisting with inflammatory conditions, speeding up recovery in athletes by repairing damaged tissue.
  • Has chelating properties which increase making minerals more bioavailable, assisting in recovery and reducing stress on kidneys.
  • Reduces stress on energy metabolism during sport and recovery.
  • Reduces the impact of free radicals during and after sport.
  • Provides optimal protection against the increased production of oxidants.
  • Provides a very powerful electrolyte.
  • Restores electrolyte balance essential for optimal muscle function and energy metabolism.

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 SAFETY AND TOXICITY

 CHD-FA™ has its own safety and toxicity work completed to allopathic standards. The safety work on CHD-FA™ can be split into two categories, namely:

  • In vitro and in vivo safety work completed on CHD-FA™
  • Safety in production

In vitro and in vivo safety work concluded

The safety of CHD-FA™ has been proven at certified GLP laboratories locally and internationally over a period of many years and at a cost of millions. This work includes the following (please note that this list is not exhaustive – if additional information is required, please contact us):

  • Bacterial Mutation Assay (Ames test): CHD-FA™ was considered to be non-mutagenic.
  • Micronucleus: The test indicated no genotoxicity for both filtered and unfiltered CHD-FA™ in an in vitro micronucleus assay.
  • BCO2 Evolution Test – Assessment of Ready Biodegradability: This test proved that CHD-FA™ is readily biodegradable under the terms and conditions of OECD Guideline No 301B.
  • Pesticides and pyrogens: Tests indicated that CHD-FA™ contains no pesticides whilst that may be the case with environmental fulvic acids.
  • Peer-reviewed Safety and Proof-of-Concept of CHD-FA™: This published article proves that CHD-FA™ is safe for systemic use at 40 ml twice a day.
  • Peer-reviewed safety in immune-compromised patients: A clinical trial published proves that CHD-FA™ is safe for use even if immunity is compromised.
  • Skin irritation testing performed in Germany.

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Safety in Production

CHD-FA™ is produced in a South African Health Products Regulatory Authority cGMP (License Nr 0000001280) and Manufacturing Pharmacy (License Nr Y54509) as well as FSSC 22000 approved facility.

For any product to be considered safe for use in human consumption, batch-to-batch consistency in production is of paramount importance. In contrast to CHD-FA™, environmental fulvic acid varies from batch to batch as it is impossible to ensure consistency.

CHD-FA™ however is a unique fulvic acid being a supramolecule – it has a fixed structure with a range of backbone structures that has been proven to be consistent from batch to batch using the following methods:

  • FTIR
  • MALDI-TOF MS
  • LC-MS
  • NMR
  • GC-MS

To ensure safety and consistency, each batch of CHD-FA™ manufactured has to pass standards as have been set up and validated. The release parameters and test specifications are as below:

  • Appearance: Visual inspection
  • pH: pH Meter <USP 38>
  • Specific Gravity: Hydrometer <USP 38>
  • Electro Conductivity: EC Meter <USP 38>
  • Identification by FTIR <Ph. Eur. Method 2.2.24>
  • Anti-Microbial Efficacy Staphylococcus Aureus total kill
  • Concentration: University of Pretoria-validated concentration method
  • Total Organic & Inorganic Impurities: Gravimetric filtration <EPA-NPDES>
  • Volatile Organic Impurities: Gravimetric filtration <EPA-NPDES>
  • Elemental impurities
  • Cd – Cadmium ICP-OES <Mals 6.4>
  • Pb – Lead ICP-OES <Mals 6.4>
  • As – Arsenic ICP-OES <Mals 6.4>
  • Hg- Mercury ICP-OES <Mals 6.4>
  • Co – Cobalt ICP-OES <Mals 6.4>
  • V – Vanadium ICP-OES <Mals 6.4>
  • Ni – Nickel ICP-OES <Mals 6.4>
  • Nitrate & Nitrite: Lachatte Flow Injector Analyser <UA EPA 353.3 >
  • Microbial Analyses: <USP 38>  & <BP 2007>
  • TAMC
  • TYMC
  • Bile tolerance gram neg bacteria
  • Salmonella spp
  • Escherichia coli
  • Aureus

Research/Efficacy on CHD-FA™

The medicinal uses of humic substances and fulvic acid have been known for many years. Medicinal products containing humic and fulvic acids with therapeutic indications for inflammation, bacterial infections, allergies, arthritis, rheumatism and various other conditions are freely available. CHD-FA™ is free of heavy metals and environmental pollutants and safe for pharmaceutical interventions. CHD-FA™ has anti-inflammatory, antibacterial, antifungal, antiviral and antioxidant properties.

It has a supramolecular structure that is characterised by twenty-four principal backbone structures embedded in CHD-FA™. The backbone structures are associated with each other and with the parent structure through intermolecular bonding to form a supramolecular structure. It is all these backbone structures (consistent from batch to batch) that give CHD-FA™ its wide range of efficacy. Three examples of these 24 backbone structures, each with their own medicinal properties, are:

  • Malic acid: Anti-inflammatory; antibacterial; antifungal; antiviral; antioxidant.
  • Tartaric acid: Anti-inflammatory; antibacterial.
  • Acetyl salicylic acid/aspirin: Anti-inflammatory; antibacterial; antifungal.

Specific research completed on CHD-FA™

Over R50 million has been spent on research work specifically on CHD-FA™. The purpose of this was to not solely rely on anecdotal data and general information but to ensure whatever efficacy is claimed in regards to CHD-FA™, there is data to support it. The studies mentioned below under each condition are just some of the studies completed on CHD-FA™ -there are many more. Please contact us if more information on the studies mentioned below or any additional studies that have been done if required.

  • Anti-inflammatory

 Many conditions in the human body are caused by inflammation. CHD-FA™ with its known anti-inflammatory properties will assist with these conditions. The following studies have been successfully completed:

  • CHD-FA™ inhibits Carrageen-induced inflammation and enhances wound healing. This peer-reviewed, published study conducted at the University of Pretoria indicated that CHD-FA™ has its anti-inflammatory effect by neutralising free radicals. The rate of reduction in the inflammation as a result of ingesting CHD-FA™ is equivalent to that of Indomethacin, a registered anti-inflammatory often used.
  • Phase 1 clinical study of the acute and sub-acute safety and proof of concept efficacy in humans. This peer-reviewed, published study also proved that CHD-FA™ acts as an anti-inflammatory.
  • Inflammatory efficacy of CHD-FA™ in an in vitro whole blood assay (human). The conclusion of this study done at Washington Biotechnology was that CHD-FA™ is a potent anti-inflammatory agent comparable to Dexamethasone.
  • In a randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of CHD-FA™ in the topical treatment of eczema, which has been peer-reviewed and published, it was found that CHD-FA™ in a cream formulation successfully improved eczema.

 Antibacterial

Bacterial and microbial infections, both systemic as well as topical, are a major health issue worldwide. Furthermore, antibiotic overuse, as well as not completing prescribed courses of antibiotics, has created a generation of resistant bacteria that, once they have invaded our bodies makes treatment very difficult. Studies at various institutions around the globe found that CHD-FA™ was successful in not only killing a wide variety of organisms, but also has the following effects:

  • Works synergistically with other medicines.
  • Is effective against a wide variety of resistant bacteria.

Antibacterial studies on CHD-FA™, including peer-reviewed and published articles:

  • CHD-FA™ is a highly-promising topical agent to enhance healing of wounds infected with drug-resistant pathogens. This peer-reviewed and published work was done at the Public Health Research Institute, Rutgers-New Jersey Medical School. The study proved that CHD-FA™ is effective against the ‘super-bug’, methicillin-resistant Staphylococcus aureus, a powerful microbe that has become of major concern worldwide.
  • Biological properties of CHD-FA™ as a potential novel therapy for the management of oral biofilm infections. This study conducted at the world-famous Glasgow Dental School, School of Medicines, was peer-reviewed and published, and concluded that CHD-FA™ exhibits broad-spectrum antimicrobial activity against orally-relevant biofilm organisms.
  • Synergistic effect of CHD-FA™. The results of this study conducted at the University of Pretoria showed that CHD-FA™ has antimicrobial activity against Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus (MRSA), Escherichia coli, Pseudomonas aeruginosa and Candida albicans. The antimicrobial spectrum of CHD-FA™ compares favourably with that of currently-prescribed antibiotics and acts synergistically with oxacillin (methicillin) and gentamicin. A Gram stain of albicans grown in the presence of CHD-FA™ showed rounded, enlarged, non-dividing bodies indicating that this product acts on the cell wall of microorganisms.
  • Assessment of the in vitro efficacy of CHD-FA ± Oxacillin following several passages in methicillin-resistant Staphylococcus aureus (EMRSA16). This study at Euprotec in the UK indicated that there is no resistance build-up by CHD-FA™.
  • Determination of the in vitro efficacy of CHD-FA™ against multidrug-resistant Enterobacteriaceae and Mycobacteria. The study concluded:
    • CHD-FA™ was effective against NDM-1, KPC and ESBL positive Klebsiella pneumonia and multi-resistant coli strains with a 100% MIC value of 0.06-0.12%.
    • CHD-FA™ was highly effective against multi-resistant Gram negative bacilli including NDM-1 positive strains. CHD-FA was also highly effective against Mycobacterium smegmatis. All organisms were inhibited using ≤0.12% of CHD-FA™.
  • Antiviral

Viruses are microscopic organisms that replicate within the cells of animals, plants and humans and subsequently cause disease. Such diseases can range from the common cold and influenza to Epstein Barr’s disease, herpes and hepatitis, to name but a few.

An in vitro study performed at the University of Pretoria showed CHD-FA™ to be fast and effective in managing feline herpes.

In vitro work was also done at Virologic in the USA against HIV strains, showing efficacy.

  • Antifungal

 Not all fungi are beneficial. Some are toxic and often cause diseases that can be both uncomfortable and dangerous. Examples include: aspergillus (can cause cancer); zygomycetes (can cause serious external skin infections and internal infections along the gastrointestinal tract); and Candida, of which there are many species with the most common one causing vaginal infections. As with many strains of bacteria, many Candida species are resistant to drugs.

A wide range of studies were performed on CHD-FA™ as an anti-fungal agent:

  • Studies carried out at Fungiscope in Germany showed that resistant Candida strains tested were inhibited by CHD-FA™.
  • Assessment of the in vivo efficacy of CHD-FA™ in a murine model of disseminated Candidiasis. This study done at Euprotec in the UK proved that CHD-FA™ is effective in vivo against Candida albicans on its own or in combination with other medicines such as Fluconazole.
  • Assessment of the in vitro efficacy of CHD-FA™ against malassezia and dermatophyte This study done at Euprotec in the UK proved that CHD-FA™:
    • inhibits the growth of Malassezia dermatis, Malassezia furfur and Malassezia globosa when used as a 0.125% solution at its native pH of 2.1 in vitro.
    • inhibits the growth of all dermatophyte strains tested, except Microsporum canis, when used as a 0.2-0.4% solution.
  • Immune Support

Because of its anti-oxidant as well as chelating and other properties such as enhanced nutritional uptake as discussed, CHD-FA™ is effective in supporting a stronger immune system.

  • Anti-Diabetic

Diabetes is a disease affecting millions of people. Because of the various healing properties of CHD-FA™, an in vivo study was conducted at the Medical Research Institute and the outcome was:

The solutions tested significantly enhanced glucose uptake both in the C2C12 muscle and Chang liver cells. The increase in the glucose uptake was comparable to that of metformin, an established anti-diabetic agent.

  • Antioxidant

The antioxidant properties are well-documented in general literature such as the article in the Journal of Food, Agriculture & Environment Vol. 9 (3&4): 123 – 127 (2011). Additional testing has also been done on CHD-FA™ confirming its excellent anti-oxidant properties.

The summary of work done at University of Pretoria concluded: “it has been shown that CHD-FA™ possesses some antioxidant properties in vitro.  This property suggests that this product may be an effective immunomodulator for the treatment of diseases associated with an overproduction of reactive oxidants by human phagocytes.”

  •  Nutritional Uptake

CHD-FA™ assist in nutritional uptake as has been proven by a study at the University of Pretoria. From the study it is clear that CHD-FA™ will assist in the nutritional uptake of various minerals.

  •  Preservative

Because of the antibacterial, antimicrobial and antifungal properties of CHD-FA™, it essentially acts as its own preservative in the various products. The preservative efficacy report by SWIFT SILLIKER confirms the preservative properties of CHD-FA™.

Production Standards and Certifications

  • South African Health Products Regulatory Authority (SAHPRA)

CHD-FA™ is produced and finished products packed in a SAHPRA cGMP (License No. 0000001280) and Manufacturing Pharmacy (License No. FY54509) Facility.

The staff component consists of highly-trained individuals in the positions of Responsible Pharmacist, Production Pharmacist, Operational Manager and Procurement as well as Financial Manager. The site has a Site Master File and full Quality Manual ensuring GMP compliance.

  • FSSC 22000

CHD-FA™ production and packaging of final products is also FSSC 22000 approved. The FSSC 22000 Food Safety System Certification provides a framework for effectively managing an organization’s food safety responsibilities. FSSC 22000 is fully recognized by the Global Food Safety Initiative (GFSI) and is based on existing ISO Standards.

  • FDA registration

The certificate affirms that Fulvimed (Pty) Ltd is registered with the U.S. Food and Drug Administration pursuant to the Federal Food Drug and Cosmetic Act,

  • South African Bureau of Standards (SABS)

The facility is audited and certified by the SABS under SANS 1828.

  • Organic Certification

CHD-FA is also certified organic by ECOCERT. This certification is both for NOP           (USDA organic regulations, 7 CFR Part 205) as well as EOS (meets the  requirements laid down in the ECOCERT ORGANIC STANDARD recognized as    equivalent with the provisions of regulation (EC) No 834/2007).

  • HALAAL

CHD-FA™ is Halaal-approved, as well as a wide variety of the products it is                            formulated and packed in.

PRODUCTS

The wide-ranging efficacy of CHD-FA™ makes it ideal for use in an extensive variety of products, as supported by the work done on CHD-FA™ and knowledge about fulvic acid in the public domain.

 

 

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