Chronic Fatigue Syndrome (CFS) and “chronic fatigue” are not interchangeable terms. So a 2004 clinical trial report indicating that dietary supplementation with NT Factor® supported significant average quality-of-life (energy) improvements for some trial subjects with chronic fatigue didn’t quite cut it. Now, the research has been expanded to include data on a clinical trial involving only patients with CFS and/or Fibromyalgia (FM). And the findings are comparable. The new report, published in the August 2006 issue of the Journal of Chronic Fatigue Syndrome, is based on three trials. In each trial, the individuals receiving the proprietary dietary supplement NT Factor® over periods of two to three months achieved “significant” average improvements in energy. The researchers – Drs. Garth Nicolson and Rita Ellithorpe, both with the nonprofit Institute for Molecular Medicine – explicitly state they have no financial interest in NT Factor®. Approach and results. All study subjects completed the 27-question Piper Fatigue Scale as a measure of energy both before the trial (at baseline) and after completing the trial. A comparison of these measures indicated the following average improvements in energy:
- 40.5 percent for the first group, which included 34 cancer patients with baseline moderate to severe fatigue associated with cell damage in chemotherapy. Their average age was 50.
- 35.5 percent for the second group, composed of 20 subjects with baseline moderate to severe chronic fatigue associated with the aging process. Their average age was 69, the oldest was over 90.
- 43.1 percent average increase in energy for subjects in the CFS/FM trial, which included 15 diagnosed subjects, also with moderate to severe fatigue at baseline. Their average age was 45.
These energy-improvement data are statistically significant, ranging from P < 0.0001 to P < 0.0001. This means the probability that they are owing to chance is less than one in 1,000. The mechanisms involved. Cell function is highly complex, but basically Drs. Nicolson and Ellithorpe cite more than 50 research reports indicating the following. The membranes of cells, and of structures within the cells such as the mitochondria (energy-generators) act as the “gatekeepers,” determining which materials will be allowed to enter or exit the membrane. When damaged by free radicals, which are associated with stresses such as infection, aging, and CFS/FM, for example, the mitochondria become “leaky” (like a rusted metal container), and can allow damaging chemicals into the cell and valuable nutrients out. The researchers explained that “at the biochemical level, fatigue is related to the metabolic energy available to tissues and cells, mainly through mitochondrial electron transport. Thus the integrity of mitochondrial membranes is critical to cell function and energy metabolism. The failure to repair or replace these damaged molecules at a rate that exceeds their damage results in impaired mitochondrial function.” The researchers further said that “Fatigue is related to cellular energy systems found primarily in the cells’ mitochondria. Damage to mitochondrial components, mainly by ROS (Reactive Oxygen Species, or free radicals) oxidation, can impair their ability to produce high-energy molecules such as ATP and NADH. This occurs naturally with aging and during chronic illnesses, where the production of ROS can cause oxidative stress and cellular damage, resulting in oxidation of lipids [fatty acids], proteins and DNA.” NT Factor® works with a unique dual protective and replacement action. The antioxidants in the formula help to reduce the current rate of damage by free radicals, and to replenish and strengthen the body’s natural protective systems. The antioxidants also protect the fatty acids in the formula from oxidative damage until they can enter the circulatory system. The unique fatty acids in the formula are the specific types utilized in cell membranes, and they actually replace the damaged oxidized fatty acids in the membranes of cells and inter-cellular structures like the mitochondria. This allows the cells to be restored to their normal fluidity, permeability, and function. The researchers noted that such Lipid Replacement Therapy (LRT) “is not just the dietary substitution of certain lipids with proposed health benefits; it is the actual replacement of damaged cellular lipids with undamaged lipids to insure proper structure and function of cellular tissues.” The study showed that the restoration of cellular energy function took place over an 8- to 12-week period, but that continued supplementation at a maintenance level was required to maintain the energy improvement. “Disease and infection can result in oxidative damage that exceeds the abilities of cellular systems to repair and replace damaged molecules, and this is also the case in fatiguing illnesses” said the researchers. Dietary supplementation to maintain cellular structure and energy function is an important lifestyle action for improved quality of life. The new report, “Lipid Replacement and Antioxidant Nutritional Therapy for Restoring Mitochondrial Function and Reducing Fatigue in Chronic Fatigue Syndrome and Other Fatiguing Illnesses,” by Garth L. Nicolson, PhD, and Rita Ellithorpe, MD, was published in the August 2006 issue of the Journal of Chronic Fatigue Syndrome, at www.haworthpress.com/web/jcfs. To read the earlier report, published with the same title in 2004 and including the same explanations minus only the CFS/FM study data, go to the ImmuneSupport.com archives.