ELLIS, John, Christian (193 Marriot Road, Musgrave, Kwazulu Natal 4001, ZA)
| 35 CLAIMS 1. A nutritional product pack comprising a combination of - (i) natural immune modulators which act as immune boosters, the immune modulators being selected from the group consisting of African Potato, Sutheriandia, Chinese Green Tea, Rooibos, Aloe Vera and Spirulina; and (ii) a source of high protein food as a food supplement. 2. The nutritional product pack according to claim 1 wherein the product pack further includes a natural water sterilization agent for adding to water in order to provide safe drinking water. 3. The nutritional product pack according to claim 1 wherein the high protein food supplement is in the form of a soya and maize porridge. 4. The nutritional product pack according to claim 3 wherein the high protein food supplement is an instant, pre-cooked cereal made from a mix of instant extruded maize and full fat soya powder. 5. The nutritional product pack according to claim 3 wherein the high protein food supplement is sweetened with sucrose and fortified with vitamins and minerals. 6. The nutritional product pack according to claim 5 wherein the soya and maize porridge comprises the following ingredients, namely maize, soya, sucrose, soy fibre, and vitamins and minerals, including dicalcium phosphate, sodium chloride, magnesium oxide, zinc oxide, ferrous fumarate, chromium citrate, vitamins A, D E, B1 , B2, B6, and B12, folic acid, biotin, nicotinamide, pantothenic acid, ascorbic acid, potassium iodide, and sodium selenite. 7. The nutritional product pack according to claim 1 wherein the source of African Potato, Sutheriandia, Rooibos, Spirulina and Chinese Green Tea are in the form of tablets, whilst the Aloe Vera is in the form of a liquid concentrate. 8. The nutritional product pack according to claim 2 wherein the natural water sterilization agent is an anti-bacterial, biocidal solution that is efficient against a wide range of micro-organisms and may contain nitric acid, heavy metal particles or a heavy metal alloy and hydrochloric acid such as disclosed in WO/1995/00470. 9. A nutritional product pack for use in stimulating and strengthening the immune system to fight infectious diseases resulting from a weakened immune system, such as HIV/AIDS, the product pack comprising - (i) a source of natural immune modulators which act as immune boosters, the immune modulators being selected from the group consisting of African Potato, Sutherlandia, Chinese green tea, Rooibos (including selenium and zinc), Aloe Vera (including Vitamin C) liquid concentrate, and Spirulina; (ii) a source of high protein food as a food supplement; and (iii) a natural water sterilization agent for adding to water in order to provide safe drinking water. 10. The nutritional product pack according to claim 9 wherein the high protein food supplement is in the form of a soya and maize porridge. 11. The nutritional product pack according to claim 10 wherein the high protein food supplement is an instant pre-cooked cereal made from a mix of instant extruded maize and full fat soya powder. 12. The nutritional product pack according to claim 10 wherein the high protein food supplement is sweetened with sucrose and fortified with vitamins and minerals. 37 13. The nutritional product pack according to claim 12 wherein the soya and maize porridge comprises the following ingredients, namely maize, soya, sucrose, soy fibre, and vitamins and minerals, including dicalcium phosphate, sodium chloride, magnesium oxide, zinc oxide, ferrous fumarate, chromium citrate, vitamins A, D E, B1, B2, B6, and B12, folic acid, biotin, nicotinamide, pantothenic acid, ascorbic acid, potassium iodide, and sodium selenite. 14. The nutritional product pack according to claim 9 wherein the source of African Potato, Sutherlandia, Rooibos, Spirulina and Chinese Green Tea are in the form of tablets, whilst the Aloe Vera is in the form of a liquid concentrate. 15. The nutritional product pack according to claim 9 wherein the natural water sterilization agent is an anti-bacterial, biocidal solution that is efficient against a wide range of micro-organisms and may contain nitric acid, heavy metal particles or a heavy metal alloy and hydrochloric acid such as disclosed in WO/1995/00470. 16. Use of a nutritional product pack for stimulating and strengthening the immune system to fight infectious diseases resulting from a weakened immune system, such as HIV/AIDS, the product pack comprising - (i) a source of natural immune modulators which act as immune boosters, the immune modulators being selected from the group consisting of African Potato, Sutherlandia, Chinese green tea, Rooibos (including selenium and zinc), Aloe Vera (including Vitamin C) liquid concentrate, and Spirulina; (ii) a source of high protein food as a food supplement; and (iii) a natural water sterilization agent for adding to water in order to provide safe drinking water. 17. The use according to claim 16 comprising the steps of administering to a subject a daily dose of 600mg Sutherlandia, 300mg African 38 Potato, 175mg Rooibos, (comprising 0.2mg Selenium and 15mg Zinc), 500mg Spirulina, 150mg Chinese green tea, 50ml Aloe Vera liquid concentrate, 100g high protein food supplement, and 1 drop of water sterilization agent per one liter of water. 18. The use according to claim 17 wherein the 50ml Aloe Vera liquid concentrate comprises 400mg of Aloe Vera and 60mg of Vitamin C. 19. The use according to claim 16 wherein the high protein food supplement is in the form of a soya and maize porridge. 20. The use according to claim 19 wherein the high protein food supplement is an instant, pre-cooked cereaj made from a mix of instant extruded maize and full fat soya powder. 21. The use according to claim 19 wherein the high protein food supplement is sweetened with sucrose and fortified with vitamins and minerals. 22. The use according to claim 21 wherein the soya and maize porridge comprises the following ingredients, namely maize, soya, sucrose, soy fibre, and vitamins and minerals, including dicalcium phosphate, sodium chloride, magnesium oxide, zinc oxide, ferrous fumarate, chromium citrate, vitamins A, D E, B1 , B2, B6, and B12, folic acid, biotin, nicotinamide, pantothenic acid, ascorbic acid, potassium iodide, and sodium selenite. 23. The use according to claim 16 wherein the source of African Potato, Sutherlandia, Rooibos, Spirulina and Chinese Green Tea are in the form of tablets. 24. The use according to claim 16 wherein the natural water sterilization agent is an anti-bacterial, biocidal solution that is efficient against a wide range of micro-organisms and may contain nitric acid, heavy 39 metal particles or a heavy metal alloy and hydrochloric acid such as disclosed in WO/1995700470. 25. A nutritional product pack according to claims 1 and 9 substantially as herein illustrated and exemplified with reference to the accompanying examples. 26. Use of a nutritional product pack according to claim 16, substantially as herein illustrated and exemplified with reference to the accompanying examples. |
I
BACKGROUND OF THE INVENTION
This invention relates to a nutritional prodjuct pack, comprising a combination of carefully selected natural supplements, which together aims to address the nutritional needs of persons infected with diseases such as human immunodeficiency virus (HIV/AIDS) by strengthening the immune system.
Some of the biggest health problems facing the world today are malnutrition, contaminated water and the HIV/AIDS epidemic. Millions of people are malnourished and are dying from opportunistic diseases such as tuberculosis and cholera, often as a consequence of HIV infection and AIDS. The HIV/AIDS epidemic and other major debilitating diseases pose an inescapable challenge to the world at large. Good nutrition is a fundamental part of the care for people living with these diseases and is one of the simplest means to help people lead longer and more productive lives. However, lack of income and other resources make it more difficult for HIV/AIDS affected households, especially those in rural areas, to supplement their diet through the purchase of more nutritious and varied foods.
It is well known and accepted in the scientific community that good nutrition can boost the immune system and energy levels. It can help maintain body weight and support the effective action of drug treatments. A person who is well nourished is stronger and better able to fight infections. The majority of people living with HIV/AIDS and related diseases live in countries where health care, resources and drugs are scarce. In addition, one of the greatest challenges facing the globe is safe drinking water for the years ahead. For those living with these diseases, good nutrition is a positive way to respond to the illness. Thus, an integral element in addressing these diseases is nutritional care.
It has been recommended that the use of good nutrition and scientifically validated traditional medicine be used for the management of HIV/AIDS. Cheap, safe, good quality and effective immune modulators will be important in the slowing down of the progression of HIV infection to AIDS. Hence, treatment using antiretrovirals may be initiated at a later date, possibly with minimisation of the development of resistance to therapy. This could result in a prolongation of life expectancy of HIV infected persons from the average current 7 years to between 15-20 years.
A need therefore exists for a strategic shift from a narrow approach that focuses on antiretroviral drugs to a developmental approach that focuses on nutrition. It is an object of the present invention to provide for a simple, affordable and effective natural and nutritional product which seeks to address malnutrition, immune deficiencies and water contamination problems.
It is acknowledged that traditional natural products including the medicinal use of plants are commonly used to treat disease and enhance general health and wellbeing. However, it is the applicants' intention to provide for a nutritional pack which as a whole and because of the particular selection of natural products provides for the complete dietary needs of individuals.
SUMMARY OF THE INVENTION
According to the present invention there is provided a nutritional product pack comprising a combination of -
(i) natural immune modulators which act as immune boosters, the immune modulators being selected from the group consisting of African Potato, Sutheriandia, Chinese Green Tea, Rooibos, Aloe Vera and Spirulina; and
(ii) a source of high protein food as a food supplement.
In a preferred embodiment of the invention, there is further provided a source of a natural water sterilization agent to provide safe drinking water.
Preferably the high protein food supplement is in the form of a soya and maize porridge. In particular, the food supplement is an instant, pre-cooked cereal made from a mix of instant extruded maize and full fat soya powder. The food supplement may be sweetened with sucrose and fortified with vitamins and minerals. More preferably, the soya-maize porridge comprises the following ingredients, namely maize, soya, sucrose, soy fibre, and vitamins and minerals, including dicalcium phosphate, sodium chloride, magnesium oxide, zinc oxide, ferrous fumarate, chromium citrate, vitamins A, D E, B1, B2, B6, and B12, folic acid, biotin, nicotinamide, pantothenic acid, ascorbic acid, potassium iodide, and sodium selenite. In a further preferred embodiment of the invention, the source of African Potato, Sutherlandia, Rooibos, Spirulina and Chinese Green Tea are in the form of tablets, whilst the Aloe Vera is in the form of a liquid concentrate.
According to a second aspect of the invention there is provided a nutritional product pack for use in stimulating and strengthening the immune system to fight infectious diseases resulting from a weakened immune system, such as HIV/AIDS, the product pack comprising -
(i) a source of natural immune modulators which act as immune boosters, the immune modulators being selected from the group consisting of African Potato, Sutherlandia, Chinese green tea, Rooibos (including selenium and zinc), Aloe Vera (including Vitamin C) liquid concentrate, and Spirulina;
(ii) a source of high protein food as a food supplement, preferably a Soya - maize porridge; and
(iii) a source of a natural water sterilization agent to provide safe drinking water.
The use comprises administering to a subject a daily dose of 600mg Sutherlandia, 300mg African Potato, 175mg Rooibos, (comprising 0.2mg Selenium and 15mg Zinc), 500mg Spirulina, 150mg Chinese green tea, 50ml Aloe Vera liquid concentrate, 100g high protein porridge, and 1 drop of sterilization agent per one liter of water.
The Aloe Vera and Vitamin C is in the form of a liquid concentrate. A daily intake of 50ml of the juice is recommended. The 50ml comprises 400mg of Aloe Vera and 60mg of Vitamin C.
The water sterilization agent may be an anti-bacteriai, biocidal solution that is efficient against a wide range of micro-organisms. In particular, the water sterilization agent may contain nitric acid, heavy metal particles or a heavy metal alloy and hydrochloric acid such as disclosed in WO/1995/00470, which is incorporated herein by reference. DETAILED DESCRIPTION OF THE INVENTION
Malnutrition, food insecurity, the HIV/AIDS pandemic and unsafe drinking water are some of the problems that the developing world, including South Africa and other African countries, are faced with. The nutritional product pack according to the invention was developed to increase wellness for people living with HIV and AIDS. The nutritional product pack consists of a combination of proteins, minerals and vitamins that provides adequate sustenance and a balanced intake of supplements to allow for one pack per person per month. It includes natural products such as the African traditional herbal plants Sutherlandia, African Potato and Aloe, in addition to Vitamins A, C and E, Selenium and Zinc, acknowledged agents in immune system enhancement.
The relationship between HIV and AIDS and poor nutrition has been well established 1 . Infection with HIV exacerbates the impact of poor nourishment, while poor nutrition hastens the progression of HIV infection to AIDS, wasting and death. The DOH identified nutrition research as a priority. The impact of nutritional programs on HIV-related morbidity and mortality, and the relationship between increased access to food and the ability of HIV-infected individuals to lead healthy lives, need to be assessed 2 .
The DOH also recognized that traditional health practitioners are an integral part of their strategy to deal with the HIV and AIDS pandemic. Research related to traditional medicines is needed as this will strengthen its inclusion in a comprehensive scientific-based approach to providing good nutrition to HIV and AIDS patients. The nutritional product pack of the invention is a user-friendly, cost-effective and multi-nutritional product pack with immune boosters and a high protein- energy base and forms the basis for a sustainable nutritional component for wellness programs. Anecdotal evidence has indicated that the benefits of using the nutritional product pack include improved quality of life through reduced feelings of nausea and fatigue, dissipation of mouth sores and body thrush, boosted energy levels, lean body mass weight gain, and reduced susceptibility to opportunistic infections.
The aim is to use this product pack as a first line of defense once an individual has tested HIV positive, especially where the patient is not able to receive ARV treatment. This pack will form the nutritional supplementation part to the treatment of the patient. In essence, the nutritional product pack will become the maintenance pack of the patient and will help build their quality of life.
The invention will now be described in more detail, by way of the following non-limiting examples only.
Although herbal preparations have been used for decades and a form of safety can be assumed, safety studies need to be done under controlled conditions. To this end, the South African Medical Research Council has conducted Phase I safety and tolerability clinical trial studies of the nutritional product pack. This was a double blind, randomized Phase I study. This Phase I study was carried out over a period of 5 weeks.
Some 48 "healthy" males participated in the study. Participants who tested positive for HIV, had grade 3 laboratory abnormalities, or tested positive for hepatitis B were excluded. Participants received the supplement pack from baseline until week 5 as per the dosing schedule shown in Table 1 below. T IB2011/001440
7
lOOmL
Recommended Wellness Pacx
8 12 2« 6 ICC but twice numb - Df Tablets * 6
50 mL placebo tablets twter
150 ml. R -onnended VVeShess Pack
C 3>. c ICC but *!W trice lurcae' of tablets
150 mt Recommended Wellness Pa k
D 12 Placebo 18 100
water *m IS placebo tablets
Table : Dosing Schedule cr tMUNITI and PLACEBO
At each visit from baseline, safety parameters including renal function, haematological and biochemical profiles were determined- The DAIDS
Grading Table was utilized for the screening of participants. Analysis of variance (ANOVA) with Scheffe's test for individual comparisons was used in the analysis.
Overall in this study of healthy participants, there were no significant consistent changes in laboratory parameters over the 5 week study period in the groups receiving the product pack at different dosages. Furthermore, when compared to study participants taking placebo, the product pack was subjectively well tolerated. No participant reported any side effects. In particular, biochemical safety parameter, haematological safety parameter and renal safety parameter tests were carried out. The specific details of each study now follow.
Regarding the renal safety parameter tests, urea, creatinine and electrolytes were measured at each time point across each dosage groups. No significant changes above the upper limit of the reference ranges of the renal parameters were present in each of the groups and over the 5 week study period. It is clear from this data that the supplement pack in all dosage groups had no efFect on renal function of the healthy participants.
With respect to the haematological safety parameter test, there were no significant changes in all study participants across all dosage groups over the 5 week study period in the hemoglobin concentration, the MCV vales, iron and ferritin levels. This shows that the supplement pack has no effect on the metabolism B12, folate and the absorption of iron from the gastrointestinal tract. Measurement of INR in all study participants was carried out to ensure that the supplement pack does not inhibit vitamin K absorption in the gastrointestinal tract. Vitamin K is important in the dotting mechanism. No significant changes in INR were found in all study participants across all dosage groups. The individual variation in INR across all dosage groups and Placebo was extremely wide. However, none of the participants in each of the dosage groups had a significantly raised I R as a result of taking the supplement pack.
For the biochemical safety parameter tests, liver function tests as measured by ALT, AST, GGT and LDH were well within the normal ranges for all participants across the treatment groups. No significant changes were found in these parameters in participants receiving 2 or 3 times the standard doses compared to the participants receiving the standard doses of the supplement pack. It is interesting to note that the baseline LDH levels tended to be higher in the placebo group from baseline to week 5. However, none of the levels were above a grade 2 according to the DAIDS table across all points. The reason for the higher LDH levels in the placebo group is unknown and could be due to normal variations. The normal range for the lipase enzyme which measures pancreatic function is 8-78 umol/l. In all study participants there were no increases above the reference range across all dosage groups. No effects on glucose tolerance were observed in all study participants across all dosage groups.
The tolerability study concluded that no study participant reported any side effects including headaches, nausea, vomiting, diarrhea, rash, fatigue or sleep disturbances. No subject needed to discontinue taking the supplement pack because of side effects.
The 8 products of the nutritional pack will now be described in more detail below.
1. SOYA-MAIZE PORRIDGE
The instant meal fortified soy-maize porridge is ideally supplied to the individual as 3 x 1kg packets, which is sufficient for a one month supply (i.e. 30 meals of 100g or 60 meals of 50g each).
Description:
An instant (pre-cooked) cereal made from a mix of instant extruded maize and full fat soy powder sweetened with sucrose, fortified with vitamins and minerals. Just add cold or hot water. The porridge may be used with sour milk, milk, fruit, yoghurt or sugar.
Ingredients:
Maize, soy, sucrose, soy fibre, vitamins and minerals (including dicalcium phosphate, sodium chloride, magnesium oxide, zinc oxide, ferrous fumarate, chromium citrate, vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, Vitamin B12, folic acid, biotin, nicotinamide, pantothenic acid, ascorbic acid, potassium iodide, sodium selenite).
Application:
The porridge may be used as an instant nutritious meal, a meal drink, a protein supplement drink/shake, or sprinkled onto food or cereal.
Nutritional Data:
Zinc 6,4 mg 43
2. SPIRULINA (Spirulina platensis) (Certified safe and non-toxic)
Spirulina is a well-known and researched "super food" blue-green algae. It consists of proteins 55-70%, carbohydrates 15-25%, lipids 5%, and minerals 7%. (Proteins are 20x more than soya and 400x more than beef by weight in the same area of farming production).
Scientifically isolated active ingredients:
More than 100 nutrients
19 Amino acids including all 9 essential amino acids:
Essential Amino Acids:
o Leucine
o Lysine
o Isoleucine
o Histidine
o Methionine
o Phenylalanine
o Threonine
o Tryptophan
o Valine
Non-Essential Amino Acids:
o Alanine
o Arginine
o Aspartic acid
o Cysteine
o Glutamic acid
o Glycine o Proline
o Serine
o Tyrosine
Minerals, including:
o Calcium (26 x more than milk) o Chloride
o Magnesium
o Iron
o Potassium
o Zinc
o Sodium
o Manganese
Enzymes including:
SOD (Super Oxide Dismutase)
Essential fatty acids:
o Louric
o Palmitic
o GLA gamma linolenic o Stearic
o Unoleic
o Alpha-Linolenic
o yristic
o Palmitoleic
o Heptadecanoic
o Oleic
o Arachidonic acid
o Gamma-Linolenic
o Sulfolipids
Natural pigment phytonutrients:
o Carotenoids {alpha & beta} o Phycocyanin
o Chlorophyll o Xanthophylls
o Zeaxanthin
o Cryptoxanthin
Vitamins: o Vlt B 12
O lt V ! ,2 ,3, 4 , 5 ,8
o Vit C
o W D
o Vit E
o Vit H (Biotin)
o Inositol
o Folic Acid
o Vrt A
o Vit K
Carbohydrates:
o Glucosamine
o Glycogen
o Rhamnose
o uramic Acid
Sterols:
o Cholesterol
o Sitosterol
o Stigmasterol
Nucleic acids:
o RNA
o DMA
Owing to Spirulina's multi-nutrient and multi-antioxidant content, it has been shown to be beneficial in the following conditions:
> Controls viruses
> Cholesterol control
> Assist the immune system > Allergy control
> Assists in controfiing cancer
> Antioxidant activity from the phycocyanin
Detoxification (liver, kidneys and blood)
Spirulina has been traditionally used in the following indications:
> Wound healing
> Chronic mental and physical fatigue
> HIV/AIDS
> Obesity (helps stabilize blood glucose levels)
> Hypoglycemia
> Stress
3. ROOIBOS (Aspaiathus linearis) (also known as "Redbush")
Naturally caffeine and tannin free. Rooibos is predominantly made up of polyphenols which are potent antioxidants. Antioxidants control the free radicals that oxidize cholesterol that results in heart attacks and strokes, and damage DNA in cells leading to cancer. 3Scientifically isolated flavonoids are listed below in descending order of availability:
Flavonoids:
o Rutin
o Aspalathin
o Orientin
o Isoorientin
o Isoquercitrin
o Hyperside
Trace Elements (present but not in enough quantity to be a
meaningful dietary source)
o Iron
o Calcium
o Potassium
o Magnesium
Extra Zinc and Selenium have been added.
The active anti-oxidants and nutrients in Rooibos plus Selenium and Zinc have been shown to be beneficial for the following conditions:
> Antioxidant helps with weak immune system
> Cancer
Venous insufficiency and venous hypertension (rutin)
> Radiation damage
Helps to prevent heart disease (antioxidant effect)
> Helps to prevent cancer (Quercin and Luteolin)
Rooibos alone have been traditionally used for the following indications: 2011/001440
16
> Antispasmodic
> Health drink
> General well being
> Skin disorders and rashes
4. GREEN TEA {Camellia sinensis)
Primarily used as an antibacterial and antioxidant
Scientifically isolated active ingredients and other phytochemicals:
Fiavonoids have antioxidant, anti-inflammatory, anti-allergic, antibacterial and antiviral effects. Tannins detoxify the system by binding to molecules and make up 25% of the fresh dried plant. Carotenoids are antioxidants.
(Table follows on page
Phenolic compounds
Phenolic acids o Cinnamic acid
o Salicylic acid
o Caffeic acid
o Tannic add
o Gallic add
o Quercetin,
Flavonoids
o Isoquercitrin
o Vitexin
o Apigenin,
o Astragalin
o Kaempferol
o Rutin
o Naringin
o Hyperoside
o Myricetin
Tannins (cated hins) (25% of total dried tea leaves) o Procyanidins
o Epicatechin,
o Epigallocatechin, o Epigallocatechingallate (EGCG)(60% of the 25%)
Terpenes (natural pigment phytonutrients)
o Carotenoids including
lutein
lycopene
o Zeaxantnin
o Beta-carotene
o Chlorophyll
Esters
o Myristic acid
o Chiorogenic add
Minerals
o Calcium
o Iron
o Magnesium
o Manganese
o Phosphorous
o Potassium
o Zinc
o Fluoride
Vitamins
o Vit B n , B 2 , B 3 , B 5 o Vitamin C Terpenoids (essential oils)
o Myroene
o Geraniol
o Thymol
o Carvacrol
o Eugenol (dental analgesic)
o Famesol
o Beta-ionone
Nutrients
Amino adds
Alkaloids
o Caffeine (very low 3.5%)
o Indole
Lipids (phytosterols)
• Beta-sitosterol
The potent antioxidants and phyto-chemicals in Chinese Green Tea have shown the following benefits:
> Help to protect against cancer
> Stimulate the immune system
> Fight tooth decay
> Chronic gastritis
> Prevention of free radical damage
> Anti-bacterial properties
> Anti-viral properties
> Lower cholesterol levels
Chinese Green Tea has also been used traditionally in the following indications:
> Promotes the burning of fat in obesity
> Beneficial for asthma
> Cholesterol reduction
> Blood pressure reduction 1440
19
> Protection against radiation
> Combats mental fatigue
> May delay the onset of atherosclerosis
> Reduce clotting tendency in blood
> Help regulate blood sugar levels
> Help regulate blood insulin levels
5. ALOE VERA (Liquid concentrate plus vitamin C) (Aloe barbadensis)
A natural liquid super nutrient concentrate. Traditional usage of Aloe Vera has shown the following benefits:
> Acts as an astringent and emollient
> Anti-bacterial
> Anti-fungal
> Anti-viral
Topically, promotes the healing of:
o burns, wounds, infections, acne, eczema, psoriasis, insect bites,
sprains, bruises, sunburn and ulcers
> Anti-tumor properties
> Promotes the healing process
> Beneficial for hemorrhoids and constipation
> Varicose veins improvement
> Detoxification
> Stimulates cell regeneration
> Ingested, helps to:
o lower cholesterol, reduces inflammation including post radiation
therapy inflammation, increases blood vessel generation in lower extremities in patients with poor peripheral circulation, soothes stomach irritation
Beneficial for the following conditions: > Thrush (Candidiasis)
> Diabetes
> Weak immune system
> Improves disorders of the gastrointestinal digestive system (e.g. inflammation of the mouth, tongue, oesophagus, stomach, colon, rectum) and vaginal inflammation.
6. AFRICAN POTATO (Hypoxis hemerocallfdea) (Also known as Inkomfe, Labatheka)
Scientifically isolated active ingredients:
> Sterols
> Sterolins
Beta-sitosterol
> Rooperol (the aglycone of hypoxoside = 4,4' - diglucoside)
African potato or phytosterols are or may be beneficial in the following conditions:
> Weak immune system
> HIV/AIDS
> Diabetes
Allergies
> Chronic inflammation
> Rheumatoid Arthritis
> Certain cancers
> Side effects of chemotherapy and radiotherapy
> Benign prostatic hyperplasia
African potato has also been traditionally used in the following indications:
> Asthma Bladder disorders
> Dizziness
> Testicular tumors
> Urinary infections
> Chronic infections
> Convalescent and strengthening tonic in adults and children with wasting diseases
> TB and cancer
> Anxiety and depression
> Prostatic hypertrophy
7. SUTHERLANDIA (Sutherfandia fmtescens)
Sub species microphylia (also known as "Cancerbush", "Kankerbos", Unwefe, Insiswa, Motlepelo, Phetola)
Sutherlandia fmtescens is regarded as the most profound and multipurpose of the medicinal plants in Southern Africa. Because of its efficacy as a safe adaptogenic tonic for diverse health conditions it has enjoyed a long history of use by all cultures in Southern Africa.
Scientifically isolated active ingredients:
> L-Canavanine (L-arginine antagonist with documented anti-viral, antibacterial, anti-fungal and anti-tumor activity)
> Pinitol (documented anti-diabetic activity)
> GABA (gamma amino butyric acid - essential for normal brain
functioning, anti-anxiety and anti-epileptic)
> Triterpenoid Glucoside (inhibitory neurotransmitter)
Sutherlandia has been shown to be beneficial for the following conditions:
> Diabetes > Anxiety
> Liver disorders
> Wasting diseases (significant anecdotal evidence of weight gain)
> Anti-HIV properties (significant anecdotal evidence of viral load lowering)
> Anti-inflammatory and analgesic
> Cancer
Sutherlandia has been traditionaity used for the following conditions.
> Diarrhoea
> Constipation
> Candidiasis / Thrush
> Cystitis
> Detoxification
> Depression
Gastritis and Heartburn
> Osteoarthritis and Rheumatoid Arthritis
> Physical and Mental Fatigue
Weak Immune System (significant evidence of CD4 count elevation)
> Gout
> TB
> Influenza and Bronchitis
> Amenorrhoea
> Cancers
> Arthritis
8. WATER STERILIZATION AGENT (Also referred to as B.A.C. 50) Biological properties of B.A.C. 50: The anti-bactericidal efficiency of B.A.C. 50 had been determined with various standard measuring systems as well as with some techniques which stimulated application conditions.
PHENOL COEFFICIENT
Organisms Solution required for the destruction of the organism within 10 min. at 20°C (in each case 1 part of product to under mentioned parts of water)
Bacteria B.A.C. 50 Phenol
Coefficient
Brucella abortus 40.700 407
Escherichia coli 27.000 338
Klebsiella pneumonia 25.000 278
Lactobacillus casei 105.000 1.050
Listeria monocytogenes 72.000 720
Mycobacterium smegmatis 21.000 309
Neisseria catarrjaoos 17.300 138
Pasteurella mulcida 54.100 492
Pseudomonas aeruginosa 14.000 175
Proteus vulgaris 12.000 171
Salmonella typhosa 45.000 500
Salmonella pulturom 25.000 278
Salmonella gallinorum 28.000 300
Salmonella typhimurium 20.000 250
Salmonella schottmuelleri 60.000 630
Shigella sonnei 25.000 313
Staphylococcus aureus 45.000 750
Streptococcus pyogenes 25.000 250
Streptococcus fecalis 150.000 2.308
Streptococcus viridans 70.000 778
Fungi Pityrosporum ovale 35.000 437
Saccharomyces cerevisiae 50.000 500
Microbiostatic and Microbiocidal Titer:
The highest dilution, capable to hinder the growths of bacteria for 48 hours (microbiostatic titer). The destruction of all organisms (microbiocidal titer) within 24 hours, is indicated in the following table:
Highest dilution (in each case 1 part of product to the under-mentioned indicated parts of water).
Organisms B.A.C. 50
Microbi tatic Microbicide
Aerobacter aerogenes 64.000 32.000
Bacillus aereurs, var. mycoides 2.000.000 -
Bacillus subtilus 2.00Ό.ΟΟΟ -
Brevibacterium ammoniagenes 2.000.000 -
Brucella abortus 2.000.000 1.000.000
Klebsiella pneumoniae 64.000 32.000
Lactobacillus casei 200.000 200.000
oniiia albicans 800.000 800.000
Penicillium luteum 1.600 800
Penicillium notatum 3.200 3.200
Pityrosporum ovale 800.00 400.000
Proteus vulgaris 16.000 16.000
Pseudomonas aeruginosa 8.000 8.000
Saccharomyces cerevisiae 400.000 200.000
Salmonella choleraesuis 60.000 60.000
Salmonella gallinarum 64.000 64.000
Salmonella pullorum 32.000 32.000 Salmonella schottmuelleri 64.000 16.000
Salmonella typhimurium 64.000 32.000
Salmonella typhosa 250.000 125.000
Shigella sonnei 32.000 32.000
Staphylococcus aureus 2.000.000 250.000
Streptococcus pyogenes 100.000 100.000
Streptococcus viridans 800.000 400.000
Trichophyton interdigitale 80.000 40.000
A.O.A.C. - Applied Dilutions:
The procedure of the A.O.A.C. dilution applied is used for the determination of the maximum dilution which can be applied after cleaning. Already efficient dilutions are:
Biocidal Properties:
Applied in very low concentrations B.A.C. 50 is efficient against a wide range of microorganisms. This is a short summary of the spectrum of activity: o Bactericidal
o Fungicidal
o Algicidal 1440
26
Bacteria:
Bacillus aereus, Bacillus subtilus, Brevi-bacterium ammoniagenes, Brucella abortus, Klebsiella pnemoniae, Lactobacillus casei, Proteus vulgaris, Listeria monocytogenes, Pseudomonas aeruginosa, Salmonella galiinarium, Salmonella thyphosa, Staphylococcus aureus, Streptococcus fecalis.
Yeasts:
Monilia albicans, Saccharomyces cerevisiae. Fungis:
Trichophyton interdigitale, Chaetomium globusum, Aspergillus niger, Coniophora puteana.
Algae:
C lorella pyrenoidosa, Anabaena cylindrica Application:
B.A.C. 50 is applied in various fields. This is a short summary of the application fields already known: o Disinfection
o Deodorizing
o Sanitizing
c Preservation Disinfection:
B.A.C. 50 is an important part of many products for the surface and skin disinfection as e.g. remedies for skin wounds, hand disinfectant for hospitals, disinfectants for floor, walls, toys, surgical and cosmetic appliances etc. The concentrations to be used are between 500-1000 ppm depending A.I.
Deodorizing:
In contrast to other products which only mask molesting odours, B.A.C. 50 is a real odour-killer. Although the exact mechanism is not entirely known, the applicant believes that the efficiency is based on an absorption or chemical reaction with the molesting odour.
Odours which result from decomposition will be prevented by the destruction of putrefactive bacteria.
A dilution of 1 : 1000 keeps kitchen, body, putrefaction and similar odours immediately under control without developing self-odour.
Preservation: a. Cosmetics
According to the cosmetic regulation of 1st August 1986, B C. 50 is allowed up to 0,5% in cosmetics. b. Pharmaceuticals
For preservation of eye drops, infection preparations, concentration: 0.01% - 0.1%. c. Technical use
B.A.C. 50 is particularly suitable against sulphate reducing bacteria at the secondary mineral oil recovering. A further big application field is the curation of slime and algae producers in swimming pools, cooling towers, air-conditioning, paper industries, etc. B.A.C. 50 is also suitable as a biological component of antiseptic aerosols and special washing agents.
Compatibility
In the following please find a list showing the already known compatibilities against various chemicals:
Compatible: citric acid, benzoic acid, boric acid, borax, wetting agents, ethylenediaminetetra acetic acid, glycerine, hydroxy acetic acid, phosphoric acid, pine oil, sodium bicarbonate, sodium carbonate, sodium aluminate, sodium nitrite, sodium pyrophosphate, sodium metaborate, trisodium phosphate, stannic chloride, urea.
Partly compatible: sodium tripolyphosphate, tetrasodium pyrophosphate, sodium metasilicate, sodium gluconate, sodium chloride, barium chloride.
Incompatible: soaps, anionic detergents, tetrasodium phosphate, ammonium chloride, cadmium chloride, disodium phosphate, ferrous chloride, lead chloride, magnesium chloride, manganous chloride, sodiummonophosphate, potassium chloride, tetrasodium metapyrophosphate, strontium chloride, titanium chloride, zinc chloride, zinc sulphate. Toxicology:
Detailed examination by independent industrial toxicological laboratories has shown BAC. 50 to be of low toxicity.
Acute Oral LD 50 (rat): approximately 900mg kg
Acute Dermal LD50 (rabbit): approximately 1 OOOmg/kg
Primary Skin Irritation (rabbit): moderate irritation
Primary Eye Irritation (rabbit): moderate irritation
The study report below reports on the nutritional content of the nutritional product pack without the porridge and relates these results to ROA of adults above the age of 12. The table below is the recommended daily dose of the nutritional product pack. In this report "IMUNITI" refers to the nutritional product pack of the invention.
Results:
Tryptophan ASM 022 gH OOg 0.19 3 - 4mg/kg 0.0035 0.0875
ADF = "Acid detergent fibre"
ADL = 'Acid detergent fignin"
Comments:
The sample was no! suitable for volatile fatty acid analysis extraction
The sample was not suitable for tannin determination as per the method the laboratory uses Manganese Not SANAS Mg kg 14.50 2.3mg 0.0266 1.1570 accredited
Mercury Not SANAS Mg kg 0.10 0.0002
accredited
Molybdenum NotSANAS Mg/kg 0.93 45pg 0.0017 3.6667 accredited
Nickel Not SANAS Mg/kg 6.50 UL = 1.0mg 0.0119 1.1930 accredited
Nitrogen Not SANAS Mg/100g 3.24 0.0597
accredited
Selenium Not SANAS Mg/kg <0.1 30 - 55Mg <0.0002 0.3273 accredited
Strontium Nol SANAS Mg kg 3 0.0055
accredited
Tin Not SANAS Mg/kg 0.59 0.0011
accredited
Titanium Not SANAS Mg/kg 5.58 0.0102
accredited
Vanadium Not SANAS Mg/kg <0.3 UL = 1.8mg <0.0006 <0.0306 accredited
Zinc Not SANAS Mg/kg 170 5 - 12mg 0.3120 2.600 accredited
Energy ASM 053 MJ/kg 17.78 170kJ/100g 0.0326 0.0212
C12:0 ASM 023 Product 0.003
C13:0 ASM 023 %Product 0.002
C14:0 ASM 023 %Product 0.064
C15:0 ASM 023 %Product 0.002
C16:0 ASM 023 %Product 0.791
C16:1 ASM 023 %Product 0.006
C17:0 ASM 023 %Product 0.012
C17:1 ASM 023 %Product 0.004
C18:0 ASM 023 Product 0.348
C18:1n9t ASM 023 % Product 0.003
UL= Upper Limit
C21.-0 ASM 023 %Product 0.008
C22:0 ASM 023 Product 0.033 i I
C22:1n9 ASM 023 %Product 0.014
C22:2 ASM 023 %Product 0.002
C23:0 ASM 023 %Product 0.004
C24:0 ASM 023 %Product 0.012
Saturated fatty acids ASM 023 %Product 1.315 Lo 1g 100g
Mono-unsalurated fatty acids ASM 023 %Praduct 1.761
Poly-unsaturated fatty acids ASM 023 %Product 4.314
Trans fatty acids ASM 023 %Product 0.007 0.1g/100g
Cis fatty acids ASM 023 %Product 5.524
Omega 3 ASM 023 %Product 0.494 100mg
Omega 6 ASM 023 % Product 3.814
Omega 9 ASM 023 %Product 1.736
EPA ASM 023 Product 0.001 65mg
* For the conversion of nitrogen content to protein content the factor of 6.25 was used
Conclusion:
Consumption of the nutritional product pack of the invention does not pose any danger in exceeding any of the RDA for all the product constituents analyzed for.
References:
1 . SAMF, 2007 & 2008
2. Merck Manual (Diagnosis and Therapy): 2007
3. Krause's Food, Nutrition and Diet Therapy; 2007
4. Otten JJ, Heliwig JP, Meyers LD (eds) 2006. Dietary Reference Intakes: The Essential guide to Nutrient requirements, The national Academic Press, Washington DC
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