Research & Publications

Published Clinical Research Studies

Lipid Replacement Therapy with a Glycophospholipid-Antioxidant-Vitamin Formulation Significantly Reduces Fatigue Within One Week

Rita R. Ellithorpe, MD | Brett Jacques, ND | Cyndee Ayson-Mitchell, MD | Robert A. Settineri, MS | Garth L. Nicolson, PhD

Anti-Aging Therapeutics

Fatigue occurs naturally during aging and in most degenerative diseases, and is the most common complaint of patients seeking general medical care. Lipid Replacement Therapy administered using an all-natural nutritional supplement containing membrane glycophos-pholipids and antioxidants can reduce or prevent fatigue. Recent clinical trials using patients with chronic fatigue have shown the benefit of Lipid Replacement Therapy in restoring mitochondrial electron transport function and reducing moderate to severe chronic fatigue. In the current preliminary study, an online survey on fatigue was used to assess the effects of a membrane glycophospholipid-antioxidant-vitamin mixture on fatigue. Fatigue was reduced within one week by a mean of 36.8% (p < 0.001) in a group of 67 subjects of mean age 57.3 years with various fatigue levels. There was no difference between the response of males and females to the supplement, and no adverse events occurred during the study.

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Dietary supplement healthy curb for reducing weight, girth, body mass, appetite and fatigue while improving blood lipid values with NT factor lipid replacement Therapy

Rita R. Ellithorpe, MD | Robert A. Settineri, MS | Garth L. Nicolson, PhD

Anti-Aging Therapeutics

Often Chronic Fatigue Syndrome [CFS) patients have weight issues, and weight reduction regimens can increase fatigue. Therefore, we initiated a weight loss clinical trial using an all natural oral supplement mixture containing an FDA-approved amaylase inhibitor plus NTFactor, which is known to safely reduce fatigue in aged subjects, chronic fatigue and CFS. The objective was to see if subjects could safely lose weight without increasing appetite and fatigue and without changing eating or exercise patterns or using drugs, herbs or caffeine. A 2-month open label clinical trial was initiated with 30 patients who used an oral mixture (Healthy Curb) of amaylase inhibitor (500 mg white kidney bean extract) plus 500 mg of NTFactor 30 min before each meal. Weight and measurements were taken weekly, appetite was assessed4 and fatigue was determined using the Piper Fatigue Scale. Sixty-three percent of the participants lost an average of 6 pounds along with 2.5 and 1.5 inch reductions in waist and hip circumference, respectively, and the entire group of participants lost an average of 3 pounds with average reductions of 1.5 and 1 inch waist and hip circumference, respectively. Participants experienced gradual and consistent weight loss along with waist and hip, body mass index (BMI) and basal metabolic rate [BMR) reductions during the entire trial. There was a 44% reduction in overall hunger with reduced cravings for sweets; therefore, notable appetite suppression occurred. Using the Piper Fatigue Scale the entire test group showed an average of 23% decrease in overall fatigue. Blood lipid profiles generally improved, suggesting improved cardiovascular health, and no adverse effects were noted clinically or found in blood chemistries.

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Calcium Disodium EDTA Chelation Suppositories: a Novel Approach for Removing Heavy Metal Toxins in Clinical Practice

Rita R. Ellithorpe, MD | Tony Jimenez, MD | Brett Jacques, ND | Robert A. Settineri, MS | Larry Clapp, JD | Garth L. Nicolson, PhD

Anti-Aging Therapeutics

Heavy metals accumulate in various tissues and are associated with increases in today's biggest killers: cardiovascular disease and cancer. Reducing these heavy metals from the body has been a challenge to modern day medicine. With the advent of intravenous EDTA chelation, it was possible to remove heavy metals, but this invasive method of heavy metal removal is burdensome and expensive. This review examines the rectal suppository method of chelating and removing toxic metals from the circulation and deposits in tissue storage sites.

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Retarding Cognitive Decline with Science-based Nutraceuticals

Rita R. Ellithorpe, MD | Robert A. Settineri, MS | Richard D. Hamill, PhD | Joshua Reynolds

JANA article

A review of five natural ingredients that combine with potential synergy to address key multiple factors common to normal and accelerated cognitive decline. A combination of well studied pleotropic ingredients has been shown to provide broad spectrum antioxidant, anti-plaque, anti-excitotoxicity and anti-infammatory neuroprotective effects, while enhancing neurotransmitter function, cerebral energy metabolism, calcium homeostasis and mitochondrial function.

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Comparison of the Absorption, Brain and Prostate Distribution and Elimination of CaNa2 EDTA of Rectal Chelation Suppositories to Intravenous Administration

Rita R. Ellithorpe, MD | Paul Mazur, PhD | Glenwood Gum, PhD | Gerry Button, BS | Julian Le, BS | Ernest H. Pfadenhauer, MS | Robert A. Settineri, MS | Garth Nicolson, PhD

Journal of the American Nutraceutical Association

Detoxamin (calcium disodium EDTA) suppositories were compared to intravenous delivery of the toxic heavy metal chelator, EDTA. The study showed that the about absorbed in the blood was about one-third equal to that of IV dosing. It also showed that Detoxamin suppositories delivered more EDTA into tissues (over 3.5 times more) that that of IV dosing. This is very important because toxic heavy metal build up over time in deep tissue. Detoxamin can get to those areas where it is needed to remove the toxic storages. This study proves that rectal suppositories are very efficient in attaining good blood levels and high tissue penetration of EDTA.

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Lipid Replacement and Antioxidant Nutritional Therapy for Restoring Mitochondrial Function and Reducing Fatigue in Chronic Fatigue Syndrome and other Fatiguing Illnesses

Rita R. Ellithorpe, MD | Garth L. Nicolson, PhD

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Mitochondria are the sites of energy production within almost every cell in our body. When mitochondria lose their function, they affect the overall energy of our physical health resulting in fatigue and a variety of illnesses. Lipid Replacement Therapy (Propax) was studied and shown to improve mitochondrial function. This review article states that Propax and antioxidants can positively affect the membranes of cells and the mitochondrial membranes by replacing certain important lipids that become damaged by oxidative stress (toxins), debilitating diseases and during the process of aging. The NT Factor within Propax replaces the damaged cellular lipids and therefore increases the overall health of the cells, tissues and organs of the body. This Lipid Replacement was shown to reduce fatigue levels, increase energy and improve the quality of life in people with illnesses that cause fatigue. The article demonstrates that Propax with NT Factor can significantly reduce severe to moderate fatigue.

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Pilot Study: Reduction of Fatigue by Use of a Dietary Supplement Containing Glycophospholipids

Rita R. Ellithorpe, MD | Robert A. Settineri, MS | Garth L. Nicolson, PhD

Journal of the American Nutraceutical Association

This study involved older volunteers, average age 50 years, who experienced varying degrees of fatigue. The group was asked to take a phospholipid-based nutrient called NT Factor. After eight weeks on this dietary supplement, all but one of the 34 people showed a significant improvement in their fatigue. The study pointed out that the integrity of cellular and intracellular membrane structures are critical to cell function and energy production in the body. Mitochondrial function (the sites of energy production within the cells) was measured after treatment with NT Factor. The supplement produced a significant increase in the mitochondrial function when assayed in the blood of participants. NT Factor restored the mitochondrial function of the people in the study to that of people almost half their age. This is a crucial find, because improvement of this structure within cells is important for the overall health of every organ, tissue and system within the body. NT Factor was proven to reduce fatigue, increase energy levels and improve mitochondrial function.

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Pilot Study: Whole Food Nutritional Supplement Increases Antioxidant Levels in the Blood

Rita R. Ellithorpe, MD

Journal of the American Nutraceutical Association

Antioxidants nutrients that reduces oxidative damage (damage of cells) such as that caused by free radicals. Free radicals are highly reactive chemicals that attack molecules by capturing electrons and thus modifying chemical structures. Antioxidants as those found in freeze-dried fruits and vegetables (Juice Plus) were found to counteract the damaging effects of oxidation. The blood antioxidant levels of thirteen patients with severe diseases were studied in this report. The test group was given whole food supplements that contain phytonutrients from 17 fruits, vegetables and grains (Juice Plus). Blood samples were taken over time and compared for antioxidant levels. The study showed that there was a substantial increase in antioxidant levels in 12 of 13 subjects after taking the freeze-dried fruit and vegetable supplements. This study provides encouragement and hope that the future will provide some remedies, and some insurance, for lifestyles falling short in the area of balanced and protective diets. Whole food nutritional supplements may be a great stopgap measure.

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A Retrospective Study of Antineoplastons A10 and AS2-1 in Primary Brain Tumours

Stanislaw R. Burzyndski, MD | Arthur B. Conde | Alonzo Peters | Benjamin Saling | Rita R. Ellithorpe, MD | James P. Daugherty | Carl H. Nacht

Antineoplastons article

The results of treatment of brain tumors have been disappointing. The objective of this study was to evaluate a new treatment with antineoplastons A10 and AS2-1. This study involved a cohort of patients who had failed established therapies and were treated in private practices in the USA and Australia. Patients received daily intravenous injections of antineoplastons A10 and AS2-1 at average dosages of 7.7 and 0.36 g/kg/day, respectively. Tumour dimensions were documented by magnetic resonance imaging. Changes in tumour size were categorised as defined by the National Cancer Institute.

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Inhibition of systemic TNF-alpha cytotoxicity in cancer patients by D-peptidoglycan

Vladimir Slesarev | Rita R. Ellithorpe, MD | Todor Dimitroff

Medical Oncology article

The current study was designed to investigate direct inhibitory effects of N-acetylglucosaminyl-muramyldipeptide (GMDP) over the cytotoxic nature of TNF-a. A lactate dehydrogenase (LDH) assay of the inhibition of TNF-a cytotoxicity was donein vitro on the following cell lines: A549 (human lung carcinoma cells), A431 (human breast cancer cells) and L929 (mouse breast cancer cells). In a double-blind placebo-controlled trial, cancer patients with an elevated activity of all five LDH isoensymes were randomized to receive either a GMDP solution or a placebo; 63 patients were evaluated every third day for the mean daily number of episodes of nausea or vomiting, changes in clinical status, cell blood count and blood chemistry. A 95% inhibition of LDH release was noticed on A549 cells. Other cell lines were less sensitive to GMDP, with an observed 72% dose-dependent reduction in LDH activity.In vivo, LDH activity was decreased by 41% (+/-4%) (mean +/-SD) in all 21 subjects who were given 0.5–1.0 mg of GMDP daily. A lowering of LDH activity by 73.4% (+/-4%) was observed in 23 patients who received GMDP at a dosage of 1.5 mg/kg daily. Correspondingly, a 10% (+/-2%) increase in LDH activity was noticed in 19 patients who were given a placebo (P<0.01). During the follow-up period, the overall clinical condition of all patients treated with GMDP was improved. No side effects were observed. In nine patients who experienced nausea from tumor toxicity before treatment, the symptom subsided. In parallel, an extremely beneficial effect on lipids metabolism was noticed in all patients with elevated cholesterol and trigliceride levels. A dietary supplementation of GMDP has been shown to reduce systemic TNF-a cytotoxicity during tumor shock.

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