Clinical studies of Primal Defense

In 1993, three single-blind, placebo-controlled studies on HSOs™ were conducted at the Dispensario Medico, Partido de la Revolucion Democratica, a medical dispensary in Irapuato, Mexico. The researchers wanted to find out whether Homeostatic Soil Organisms™ could help people with high cholesterol and leukemia. They also wanted to see if the HSOs™ made test subjects feel more energetic and improved memory and concentration.

* High cholesterol: Seventy patients with blood cholesterol counts higher than 300 milligrams per deciliter were given HSOs or a placebo. Subjects given the HSOs™ saw their total blood cholesterol count drop by 25 percent or more; the placebo subjects showed no change.

* Energy levels, memory and concentration: Seventy patients with no known pathologies were given HSOs™ or a placebo. Thirty-three of the 35 subjects given HSOs™ reported feeling more energetic and vital. HGB (hemoglobin) levels and red blood cell counts increased moderately in 33 subjects. In the placebo group, no subjects reported an increase in energy or vitality levels. Only two subjects out of 33 (two subjects dropped out of the study) saw their HGB levels increase. In only one subject did the red blood cell count increase. Conspicuous increases in memory and concentration improved in 28 out of 35 test patients with only 1 improving in the placebo group.

* Chronic Lymphocytic Leukemia stage II: Thirty-five subjects with chronic lymphocytic leukemia (CLL) were given HSOs™. The director of research reported that HSOs "attenuated the symptoms of approximately 80 percent of the treated patients." In 80 percent of the subjects, white blood cell counts improved.

Results from additional studies:

* In a study conducted at Bio Inova Life Sciences Laboratories under the direction of Pierre Braquet, PhD. and Jean Michel Mencia-Juerta, PhD., researchers attempted to identify the anti-microbial properties of Primal Defense™ HSOs™. They were found to be effective in inhibiting various pathogenic microorganisms, including Psuedomonus aeruginosa, a disease-causing microorganism.

* Another study conducted at Bio Inova Life Sciences Laboratories evaluated the effectiveness of Primal Defense™ HSOs™ on the immune system. In this study, researchers looked at natural killer (NK) cells and macrophage function. Natural killer cells roam the bloodstream looking for and destroying foreign-invader cells. Macrophages are large white blood cells that also serve the immune system by killing foreign invaders. In the study, Primal Defense™ were found to boost the immune system by enhancing the function of natural killer cells and macrophage function.

* In another study at Bio Inova Life Sciences Laboratories, Primal Defense™ HSOs™ were examined with a view toward how they affect cancer cells. They were shown to inhibit the proliferation of cancer cells in the breast, liver and lung.

* In another study at Bio Inova Life Sciences Laboratories, Primal Defense™ HSOs™ were shown to enhance the production of healthy cells in the colon which may positively effect those suffering from severe digestive disorders, and oxidative stress.

* In an open-label, 120-day clinical pilot study conducted by Paul A. Goldberg, M.P.H, D.C. at the Goldberg Clinic in Marietta, Georgia, 16 individuals suffering from complex digestive and immune-system disorders were given Primal Defense™ HSOs™ for 120 days. The subject’s gastrointestinal and immune system disorders had been resistant to conventional and complimentary treatments. They had a variety of chronic diseases that were unresponsive to medical intervention for a minimum of three years. The subjects ranged in age from 20 to 65. No dietary or lifestyle changes were made. Fifteen of the 16 subjects reported clinical improvements in their overall health. They had partial to full relief from troublesome bowel problems, decreases in asthmatic symptoms, increases in energy levels, improvements in skin conditions, improvement in chronic sinus infection, and general improvement in overall well-being. No subjects reported a worsening of their symptoms. Eight of nine subjects with elevated yeast levels as verified by stool and/or blood tests had a significant reduction in Candida yeast growth. Three subjects with asthma had a 50 percent or greater reduction in usage of inhalant medications and asthma symptoms. One subject, a physician with chronic pulmonary fungal infection, reported greater ease in breathing and improvement in spirometer readings as evidenced by her medical pulmonologist. Moreover, three subjects who suffered from long-term chronic constipation and had laxative dependency were able to move their bowels daily without the use of laxatives. Three subjects with chronic IBS showed between 25 and 100 percent improvement. Four patients with chronic fatigue syndrome were completely free of symptoms by the end of the 120-day period. Before and after blood tests and physical examinations showed that no subject experienced a worsening of conditions or exhibited any evidence of toxicity.

Clinical placebo controlled studies were conducted at the Peoples University of the Americas in Ponce, Puerto Rico.

* A 90-day, 70-patient, blind placebo-controlled clinical study published in Progress in Nutrition, evaluated the effectiveness of Primal Defense™ HSOs™ as a primary treatment for chronic digestive disorder and malabsorption syndrome. Thirty-one patients in the study group and 14 patients in the placebo group completed the study. Some 52 percent of those taking Primal Defense™ achieved full remission of symptoms; 32 percent of the participants achieved greater than 40 percent improvement of symptoms; no subjects had zero improvement of symptoms or a worsening of symptoms.

According to the director of the study, Primal Defense™ qualifies as an accomplished therapy with "significant efficacy" for treating chronic digestive disorders coupled with malabsorption syndrome.

Additional data from studies conducted on Primal Defense™ HSOs showed the following results:

HSOs (Homeostatic Soil Organisms™) Clinical Studies

1) Individuals consuming Primal Defense had a marked increase in blood levels of several key enzymes including Amylase, Lipase and Protease.

2) After consuming Primal Defense™, 18 individuals with low blood protein levels at the beginning of the study had an increase in blood protein levels which signifies improved absorption and utilization of protein from the diet.

3) Individuals consuming Primal Defense™ had a marked improvement in symptoms of anemia and the use of the product seemed to have a "blood building" effect.

4) Individuals consuming Primal Defense™ had a marked improvement in blood levels of key minerals.

5) Individuals consuming Primal Defense™ with abnormal immune markers showed a trend towards a modulation of the immune system as evidenced by a decrease in White Blood Cells an increase in Neutrophiles a normalization of Lymphocytes and a decrease in elevated Monocytes, Eosinophiles and Basophiles.

In addition, a significant number of beneficial observations were made in the course of the studies. These were beyond the scope of the established protocol and therefore were not incorporated into the official reports published in Progress in Nutrition:

* Fourteen patients (nine females, five males) reported remarkable increases in their energy levels beginning toward the end of the second month and continuing through the full course of treatment.

* Three female patients having suffered from chronic, recurrent migraine headaches, reported total remission from their headaches by study’s end.

* Six patients (five females, one male) having suffered from various grades of chronic skin rash, reported total remission of these symptoms.

* Six patients (four females, two males) reported significant vanishing of some of their facial wrinkles by the end of the study.

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