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Fatigue Reduced By 37 Percent In One Week

Lipid Replacement Therapy with a Glycophospholipid Antioxidant Vitamin Significantly Reduces Fatigue

Author: NTFactor®/Tuesday, October 16, 2012/Categories: Clinical Trials

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 glycophospholipids 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 try 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.

Chronic or intractable fatigue that is not reversed by sleep is the most common complaint of patients seeking medical care. It occurs naturally during aging, and is also an important secondary condition in many degenerative diseases. The phenomenon of fatigue has been defined as a multidimensional sensation, and clinical studies have determined the extent of  fatigue in aging and in various medical conditions. Many diseases are associated with fatigue, including neurological, respiratory coronary, musculoskeletal, metabolic and gastrointestinal  diseases, as well as infections and cancer.

Most people understand  fatigue as a loss of overall energy and inability to perform even simple tasks without exertion. At the cellular level, fatigue is related to cellular energy systems  found primarily in the cells' mitochondria. Damage to  mitochondrial components, especially mitochondrial membranes,  occurs mainly by oxidation, and this can result in increased ion leakage across mitochondrial membranes and impair the ability of mitochondria to produce high-energy molecules needed for  survival and growth. During aging and most chronic diseases, the production of oxidative molecules such as Reactive Oxygen and Nitrogen species  (ROS/RNS, oxidative and oxygen- and nitrogen-containing molecules such as nitric oxide, oxygen and hydroxide radicals and other molecules9), can cause oxidative stress and cellular damage, resulting in oxidation of lipids, proteins and DNA. When oxidized, these molecules are structurally and sometimes functionally changed.l2,i3 Important targets of ROS/RNS damage are mitochondria and cell membranes, mainly, their phospholipids components. Similar damage occurs in fatiguing illnesses such as chronic fatigue syndrome (CFS). whereby patients have intractable fatigue for at least six months and show increased susceptibility to oxidative stress and peroxidation. 

Recent clinical trials have shown the effectiveness of lipid replacement therapy (LRT) plus antioxidants in the treatment of certain clinical disorders and conditions such as chronic fatigue. LRT results in the actual replacement of damaged cellular lipids with  undamaged  (unoxidized) lipids to ensure proper function of cellular structures, mainly  cellular and organelle membranes. LRT can result in the cellular delivery of unoxidized, undamaged membrane glycophospholipids in order to replace damaged lipids and restore function to oxidized cellular membranes.Combined with antioxidant supplements, LTR has proven to be an effective method to prevent ROS/RNS-associated changes in cellular activities and functions and for use in the treatment of various clinical conditions.

In this study, we tested the results of using a formulation of glycophospholipids plus antioxidants and B-complex vitamins on suppression of fatigue during a one week trial.

Participants were prescreened on the basis of an initial phone conversation to determine if their  symptoms were consistent with persistent, intractable fatigue, or merely an intermittent condition linked to their work or lifestyles. Those who described a condition consistent with the definition of fatigue as defined in  the Piper Fatigue Scale (PFS) were directed to take an online survey. This instrument defines fatigue as an unusual sense of tiredness that is not usually relieved by either a good night's sleep or by rest. Subjects were asked if they used any prescription medications to see if this might exclude them from the study. The completed online surveys were scored as described previously.

After the initial PFS survey, 75 participants with an overall PFS fatigue score greater than 3 were admitted to this pilot study if their fatigue could not be explained by a pre-existing clinical condition.  There were 67 respondents who fully completed the study with an average age of 57.3 ± 1.5, and a range of 24 - 87.

Study Design:
Subjects signed an online informed consent document and were admitted into the study with measurable fatigue (3-10 on the PFS). Each participant was given instructions to use five tablets of the glycophospholipid supplement containing antioxidants and vitamins daily. All subjects repeated the online PFS assessment at the end of the first week without access to their previous scores. After the participants completed their PFS questionnaires, all of the electronic forms were checked for verification, completion and scoring accuracy. 

Materials and Methods: 
The supplement product, NTFactor® Advanced Physicians Formula with B-Vitamin Complex (Nutritional Therapeutics, Inc., Commack, NY), is a patent-pending proprietary vitamin, mineral and nutrient complex containing an exogenous source of polyunsaturated phosphatidylcholine and other membrane phospholipids. The participants took the suggested daily dose (3 tablets in the morning and 2 at night) for one week.

The PFS is composed of 22 numerically scaled questions rated from 0 (no fatigue) to 10 (severe) fatigue. These items measure four  dimensions of subjective fatigue; behavioral/severity (6 items); affective/meaning (5 items); sensory (5 items); and cognitive/mood (6  items). These answers are used to calculate the four sub-scale/dimensional  scores and the total fatigue scores. The standardized alpha (Cronbach's alpha) did not drop below 0.90 for any of the subscales, and the standard alpha for the entire scale of 22 questions was 0.96, indicating excellent reliability for an established instrument.

The  glycophospholipid antioxidant vitamin supplement used in this study (Table l) improved the overall fatigue scores of moderately fatigued subjects as measured by the PFS.  The initial PFS group average (mean ± standard error mean) total fatigue score was 9.56 ± 0.36, and after one week of supplement this score improved to 6.02 ± 0.295 or a 36.8% reduction in fatigue. The mean decrease in  fatigue value was significant by  t-test (p  < 0.001) and Wilcoxon signed-rank (p <  0.001) analyses. There were no  adverse events during the course of  the study. We examined participants' data to see if  there was any difference between males and females. There was no statistical significance between the response in males and females.

The Piper Fatigue Scale can be further dissected into subcategories  that include overall fatigue, behavior/severity, affective meal)ing, sensory and cognitive/mood. All of these subcategories  showed reduction s of 34.6% to  40.6%  at the end of the one-week trial, indicating that there were improvements in all subcategories of fatigue.

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