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International Journal of Clinical Medicine, 2012, 3, 163-170
doi:10.4236/ijcm.2012.33034 Published Online May 2012 (http://www.SciRP.org/journal/ijcm) 163
Lipid Replacement Therapy with a Glycophospholipid
Formulation with NADH and CoQ10 Significantly Reduces
Fatigue in Intractable Chronic Fatiguing Illnesses and
Chronic Lyme Disease Patients
Garth L. Nicolson1*, Robert Settineri2, Rita Ellithorpe3
1Department of Molecular Pathology, The Institute for Molecular Medicine, Huntington Beach, USA; 2Sierra Research, Irvine, USA;
3Tustin Longevity Center, Tustin, USA.
Email: *gnicolson@immed.org
Received January 17th, 2012; revised February 25th, 2012; accepted March 19th, 2012
ABSTRACT
Objectives: A preliminary open label study was initiated to determine if a combination oral supplement containing a
mixture of phosphoglycolipids, coenzyme Q10 and microencapsulated NADH could affect fatigue levels in long-term
patients with intractable fatigue. Fatigue was determined by the validated Piper Fatigue Scale before, during and after
the trial. Participants included 58 patients (30 females and 28 males) with chronic fatigue syndrome/myalgic encepha-
lomyelitis, chronic Lyme disease or other fatiguing illnesses, such as fibromyalgia syndrome or Gulf War illness. These
patients had been symptomatic for an average of 17.1 ± 0.6 years, had been seen by many physicians (15.2 ± 0.7) and
had used many other supplements and drugs (35.4 ± 2.7) without apparent reductions in their fatigue. Results: Partici-
pants in the study responded to the combination test supplement, showing a 30.7% reduction in overall fatigue within
60 days (P < 0.001). Analysis of subcategories of fatigue indicated that there were significant improvements in the abil-
ity to complete tasks and activities as well as significant improvements in mood and cognitive abilities. Regression
analysis of the data indicated that reductions in fatigue were gradual, consistent, and occurred with a high degree of
confidence (R2 = 0.960). The data also suggested that further reductions were likely if the participants had continued the
supplement beyond the 8-week trial. Males responded slightly better to the combination supplement than females, and
the patients with the most severe forms of fatigue responded slightly better than those with milder fatigue, independent
of their diagnosis. Conclusions: The combination supplement was a safe and effective method to significantly reduce
fatigue in long-term patients with intractable chronic fatigue.
Keywords: Fatigue; Chronic Fatigue Syndrome; Lyme Disease; CoQ10; NADH; Phospholipids
1. Introduction
In the last few years natural supplements have been used
to reduce fatigue in patients with chronic fatigue and other
chronic illnesses [1,2]; however, few if any of these natural
supplements were considered effective [2]. Chronic or
intractable fatigue that is not reversed by sleep is the
most common complaint of patients seeking general
medical care [3,4]. Fatigue occurs naturally during aging,
and it is also an important secondary condition in many
chronic diseases [4].
Fatigue and especially chronic fatigue have been de-
scribed as a multidimensional sensation, and clinical
studies have determined the extent of fatigue in aging and
in various medical conditions (neurological, respiratory,
coronary, musculoskeletal, metabolic, autoimmune and
gastrointestinal diseases, cancer, infections) [3,5-7]. Most
patients consider fatigue to be a loss of overall energy
and inability to perform even simple tasks without exer-
tion [3,4]. At the cellular level fatigue is related to cellu-
lar energy systems found primarily in the cellular mito-
chondria and specifically in the inner mitochondrial
membrane electron transport chain [8,9]. Damage to mi-
tochondrial components, especially mitochondrial mem-
branes, occurs in various diseases, mainly by oxidation,
and this can result in increased ion leakage across mito-
chondrial membranes and impairment in the ability of
mitochondria to produce high-energy molecules needed
for survival and growth [10,11].
During aging and most chronic diseases the production
of oxidative molecules, such as Reactive Oxygen and
*Corresponding author.
Copyright © 2012 SciRes. IJCM
Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly
Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients
164
Nitrogen species (ROS/RNS) that are free radical oxy-
gen- and nitrogen-containing molecules, such as nitric
oxide, oxygen and hydroxide radicals and other molecules,
can cause oxidative stress and cellular damage [10-12].
This results in oxidation of lipids, proteins and DNA
[10-13]. When oxidized, these molecules are structurally
and sometimes functionally changed [13,14]. Important
targets of ROS/RNS damage are cellular membranes, and
in particular, mitochondrial and membranes, especially
their phospholipid components [11-14].
In fatiguing illnesses, such as chronic fatigue syndrome/
myalgic encephalomyelitis (CFS/ME), patients have in-
tractable fatigue for at least six months and show in-
creased susceptibility to oxidative stress and peroxidation
of membrane lipids [15,16]. To some degree this excess
oxidative stress can be reduced with antioxidant supple-
ments [18,19], but these antioxidants cannot repair the
oxidative damage to cells.
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 [6,12]. 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, undam-
aged 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 func-
tions and for use in the treatment of various clinical con-
ditions [6,12,20].
Here we tested the results of using a formulation of
glycophospholipids, CoQ10 plus microencapsulated NADH
and other nutrients on suppression of fatigue during an
open label two-month trial. The subjects in this study
were long-term chronic illness patients with intractable
fatigue that had tried unsuccessfully many drugs and sup-
plements to reduce their fatigue.
2. Materials and Methods
2.1 Materials and Methods
An open label, institutionally approved, clinical trial was
initiated to study the effects of an all-natural supplement
on fatigue. The supplement product, ATP Fuel®, con-
taining NT Factor®, microencapsulated NADH, CoQ10,
pro- and pre-biotics and other nutrients (Researched Nu-
tritionals, Inc., Los Olivos, CA), is a patent-pending pro-
prietary nutrient complex containing an exogenous source
of polyunsaturated phosphatidylcholine, phosphatidy-
glyerol, phosphatidylserine, phosphatidylinositol, and
other membrane phospholipids, as well as coenzyme Q10
(CoQ10), microencapsulated reduced nicotinamide ade-
nine dinucleotide (NADH) and other micronutrients (Ta-
ble 1). The participants took the suggested daily dose (5
capsules in the morning and 5 at night) for 8 weeks.
Table 1. Test supplement (ATP Fuel® with NTFactor®, NADH and CoQ10)‡.
Component Amount per Serving % Daily Value*
Vitamin E (as D-α-tocopheryl succinate, mixed tocopherols) 20 IU 67
NADH and Coenzyme Q10 35 mg **
Calcium (as dicalcium phosphate, carbonate, pyruvate
borogluconate, ascorbate and dicalcium pantothenate)
phosphorus (as dicalcium phosphate), magnesium
(as magnesium oxide)
260 mg 13
Alpha keto glutaric acid, L-tyrosine 180 mg **
L-Carnipure® (L-carnitine L-tartrate), pantethine 160 mg **
NT Factor®# 2000 mg
**
‡ATP Fuel® is a registered trademark of Researched Nutritionals, Inc., Los Olivos, CA; *Daily values are based on a
2000 calorie per day diet; **Daily values not established; #NT Factor® is a nutrient complex extracted from soy lipids
and purified using proprietary processes. It is composed only of food and food components: phosphoglycolipids (poly-
unsaturated phosphatidylcholine, glycolipids and other polyunsaturated phosphatidyl nutrients), Bifido and Lactobac-
cillus bacteria (freeze-dried and microencapsulated in viable form), growth media (bacterial growth factors and food,
including rice bran extract, arginine, beet root fiber, black strap molasses, glycine, magnesium sulfate, para-amino ben-
zoate, leek, pantethine, taurine, garlic, calcium borogluconate, potassium citrate, spriulina, bromelain, natural vitamin E,
calcium ascorbate, -lipoic acid, oligosaccharides, vitamin B-6, niacinamide, riboflavin, vitamin B-12, folic acid, inositol,
calcium pantotenate, chromium ficolinate). NT Factor® is a registered trademark of Nutritional Therapeutics Inc.,
Commack, NY.
Copyright © 2012 SciRes. IJCM
Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly
Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients 165
Fatigue was scored using the Piper Fatigue Scale (PFS).
The PFS is a validated instrument composed of 22 nu-
merically scaled questions rated from 0 (no fatigue) to 10
(severe fatigue) [21,22]. These items measure four di-
mensions of subjective fatigue: behavioral/severity (6
items); affective/meaning (5 items); sensory (5 items);
and cognitive/mood (6 items). These are used to calculate
the four sub-scale/dimensional scores and the total fa-
tigue scores. The standardized alpha (Cronbach’s alpha)
coefficient of reliability did not drop below 0.960 for any
of the subscale data, and the standard alpha for the entire
scale of 22 questions was 0.979, indicating excellent re-
liability and internal consistency for this established in-
strument [23]. The study participants took the PFS survey
at days 0, 7, 30 and 60.
2.2. Subjects
Participants were prescreened after an initial contact to
determine whether their symptoms were consistent with
persistent, intractable fatigue, or merely an intermittent
condition linked to their work, lifestyle or sleep patterns.
Those who described a condition consistent with the
definition of moderate to severe fatigue as defined in the
PFS [20-22] were directed to take an online survey after
they completed an Informed Consent document. A fol-
low-up was conducted to determine any physician’s di-
agnosis as well as complete description of their condition
and laboratory tests that were used to confirm their diag-
nosis (Table 2). Potential subjects were also asked how
long their condition existed, whether it had been affected
by any drug or supplement, and how many physicians
they had been to before entering the trial. They were also
asked if they were currently using any prescription
medications to see if this might exclude them from the
study, as determined previously [26]. The completed on-
line surveys were scored as described previously [27].
After the initial PFS survey and confirmation of their
condition, 68 participants with an overall PFS fatigue
score greater than 5 were admitted to this open-label pilot
study, if their fatigue could not be explained by a pre-
existing clinical condition. There were 58 respondents
(30 females and 28 males) who were fully compliant and
completed the study. The mean age ± standard deviation
(SD) of participants completing the study was 55.0 ± 1.4
years (females, 51.8 ± 1.7 years and males, 58.5 ± 2.1
years, respectively).
2.3. Study Design
Subjects signed an informed consent document and were
admitted into the study with measurable moderate to se-
vere fatigue (5 - 10 in the overall average PFS). Each
participant was given instructions to take the glycophos-
pholipid supplement with NADH and CoQ10 daily after
an initial PFS assessment (time 0). All subjects repeated
the PFS assessment at the end of the first week on line
without access to their previous scores. After the partici-
pants completed their PFS questionnaires at 30 and 60
days, all of the electronic forms were checked for verifi-
cation, completion and scoring accuracy [27].
2.4. Statistics
Data were analyzed by ANOVA, with significance de-
fined as P < 0.05. Further data analysis was performed
with Tukey test and linear regression analysis, with sig-
nificance defined as P < 0.05. The standardized alpha
(Cronbach’s alpha) was used to confirm reliability and
internal consistency of the data [23].
Table 2. Study participants’ diagnosis.
No. Patients* Diagnoses** Notes on Diagnoses
30 Chronic Fatigue Syndrome Myalgic encephalomyelitis (CFS/ME) Canadian
consensus definition [24]
17 Lyme Disease Symptoms, positive Western blot analysis [25]
16 Other Fatiguing Illnesses Fibromyalgia syndrome, Gulf War illness
4 Autoimmune Disease Rheumatoid arthritis
2 Cancer Active, secondary disease
2 Diabetes Active, under control
*Some patients had more than one diagnosis; **Diagnosis made by physician of record.
Copyright © 2012 SciRes. IJCM
Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly
Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients
166
3. Results
3.1. Subjects in the Study
The subjects in this study were long-term chronic illness
patients who had moderate to severe chronic fatigue for
years without improvement (mean ± SD years without
improvement of fatigue = 17.1 ± 0.6 years). Most had
been to multiple physicians (mean ± SD = 15.2 ± 0.7) and
had taken a variety of drugs and supplements (mean ± SD
= 35.4 ± 2.7) without expected relief of their fatigue
symptoms. As expected, the majority of the subjects (n =
30) had a diagnosis of chronic fatigue syndrome/myalgic
encephalomyelitis (Canadian consensus definition), but
there was a significant group (n = 17) that had chronic
Lyme disease (over two years, confirmed by Western blot
analysis) or other fatiguing illnesses (n = 16, fibromyal-
gia syndrome or Gulf War illness) (Table 2). Of the 68
subjects that started the study, 58 completed the study.
Almost all of the subjects that withdrew from the study
did so without ever completing the day 0 PFS survey and
taking the test supplement, or they were omitted from the
data analysis for non-compliance during the trial. One
participant left the trial because of severe headaches,
which had occurred intermittently before the trial, and
one participant left because of gastrointestinal complaints.
In both cases these symptoms resolved after stopping the
test supplement, and no further complaints were recorded.
3.2. Effects of Test Supplement on Fatigue
We examined the effects of the combination glycophos-
pholipid-NADH-CoQ10 preparation used in this study
(Table 1) on fatigue scores in a 2-month open label trial
and found significant improvements in the overall fatigue
scores of the 58 study subjects as measured by the PFS
(Table 3). The initial PFS group mean total fatigue score
± SD was 7.51 ± 0.29, and after 8 weeks of supplement
this improved to 5.21 ± 0.28, or a 30.7% reduction in
fatigue. The mean decrease in fatigue scores was signifi-
cant by t-test (P < 0.0001) and Wilcoxon signed-rank (P
< 0.0001) analyses.
The PFS can be further dissected into subcategories
that include: behavior/severity, affective meaning, sen-
sory and cognitive/mood (Table 3). All of these sub-
categories showed significant reductions at the end of the
8-week trial (P < 0.0001), indicating that there were sig-
nificant improvements in all subcategories of fatigue. For
example, there was a 30.7% reduction (P < 0.0001) in
severity/behavior of fatigue, indicating that there was a
significant reduction in the intensity of fatigue, and a
significant increase in the ability to complete tasks, so-
cialize and engaging in sexual and other activities. Also,
there was a 28.0% improvement (P < 0.0001) in mood
and cognitive ability, such as the ability to concentrate,
remember and think clearly (Table 3).
3.3. Regression Analysis of Fatigue Data
To see if the trends in fatigue reduction over time during
the trial were consistent, occurred with a high degree of
confidence and could predict further reductions we con-
ducted regression analyses of the data. As shown in Fig-
ure 1, the regression analysis of overall fatigue in each of
the subcategories of fatigue (behavior/severity, affective
meaning, sensory and cognitive/mood) indicated signifi-
cant and consistent downward trends in the fatigue data,
suggesting that further reductions in fatigue would have
been likely if the trial had been continued (Figure 1). The
regression R2 values for the various subgroups were: be-
havior/severity, 0.956; affective meaning, 0.960; sensory,
0.950; and cognitive/mood, 0.980. Regression analysis of
the overall fatigue yielded a R2 = 0.960. This indicates a
high level of confidence in the downward trends in all
fatigue data.
Table 3. Results from overall fatigue and subcategories of the piper fatigue scale survey.
Category Mean Fatigue
Day 0 Level ± S.E.M.
Day 60 Percent
Reduction t-test
P
Overall Fatigue 7.51 ± 0.29 5.21 ± 0.28 30.7 <0.0001
Behavior/Severity 7.43 ± 0.26 5.15 ± 0.12 30.7 <0.0001
Affective/Meaning 8.36 ± 0.14 5.90 ± 0.16 29.4 <0.0001
Sensory 7.75 ± 0.22 5.49 ± 0.17 29.2 <0.0001
Cognitive/Mood 6.40 ± 0.24 4.61 ± 0.21 28.0 <0.0001
Copyright © 2012 SciRes. IJCM
Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly
Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients 167
3.4. Regression Analysis of Data Based on Sex
We examined participants’ data to see if there was any
difference between males and females. Differences be-
tween the response to the test supplement in males and
females were obvious in the regression analyses (Figure
2). Females showed more fatigue at the beginning of the
trial as well as at the end compared to males (Figure 2).
Males showed an average of 35.9% improvement in
overall fatigue by the end of the trial (P < 0.0001),
whereas females ended the trial with an average im-
provement in fatigue of 23% (P < 0.0001). The regres-
sion analysis R2 values for males = 0.951, and for fe-
males R2 = 0.970. This indicates a high level of confi-
dence in the fatigue data in both males and females.
Figure 1. Data regression analyses of various patient sub-
groups taking the test supplement in a 60-day trial. X axis,
days; Y axis, Piper Fatigue Score. The regression R2 values
for the various subgroups were: G1: behavior/severity, 0.956;
G2: affective meaning, 0.960; G3: sensory, 0.950; and G4:
cognitive/mood, 0.980. Total: regression analysis of the over-
all fatigue, R2 = 0.960.
Figure 2. Data regression analyses of male and female sub-
groups taking the test supplement in a 60-day trial. X axis,
days; Y axis, Piper Fatigue Score. The regression R2 values
for males was 0.961, and females, 0.970.
3.5. Analysis of Data Based on Severity or
Diagnosis
We also examined the data to see if there was a differ-
ence in response to the test supplement that was depend-
ent on fatigue severity. As expected from previously tri-
als that used NT Factor® alone [28], the most severely
fatigued subjects showed the greatest reductions in fa-
tigue scores. For example, subjects with initial overall
fatigue scores above 8 in the PFS scale showed greater
reductions in fatigue scores on day 60 (35.3% improve-
ment in overall fatigue) than subjects with lower scores
(intial PFS score 4 - 8, 25% improvement by day 60).
Examination of chronic fatigue syndrome/myalgic en-
cephalomyelitis, Lyme disease or other diagnosis catego-
ries did not reveal major differences in overall fatigue or
its reduction by the test supplement that were related to
diagnosis. For example, the CFS/ME, Lyme disease and
other fatiguing illness groups total fatigue was reduced
on day 60 by 29.6%, 27% and 34.6%, respectively. The
differences between the diagnosis groups on day 60 were
not significant. However, in these diagnosis subgroups
differences between initial overall fatigue at day 0 and
overall fatigue on day 60 were highly significant (P <
0.0001).
4. Discussion
LRT using the glycophospholipid supplement NT Fac-
tor® has been used successfully in animal and clinical
lipid replacement studies [6,12,20,26-28]. In this formu-
lation encapsulated lipids are protected from oxidation in
the gut and can be absorbed and transported into tissues
without oxidative damage. NT Factor® contains a variety
of components, including phospholipids, glycophosphol-
ipids and other lipids, nutrients, probiotics, vitamins,
minerals and plant extracts [6,12].
In animal studies NT Factor® has been used to prevent
hearing loss associated with aging [30]. Seidman et al.
[30] found that NT Factor® prevented hearing loss asso-
ciated with aging and shifted the threshold hearing from
35 - 40 dB in control aged animals to 13 - 17 dB in the
treatment group (p < 0.005). They also found that NT
Factor® preserved cochlear mitochondrial function. NT
Factor® also prevented aging-related mitochondrial DNA
deletions found in the cochlear [30].
LRT has also been successfully used in clinical studies
to reduce fatigue and protect cellular and mitochondrial
membranes from oxidative damage [6,12]. For example,
NT Factor® has been used in a vitamin and mineral mix-
ture (PropaxTM) in cancer patients to reduce the effects of
cancer therapy, such as chemotherapy-induced fatigue,
nausea, vomiting and other side effects associated with
chemotherapy [30,31]. In a double-blinded, cross-over,
Copyright © 2012 SciRes. IJCM
Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly
Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients
168
placebo-controlled, randomized trial on cancer patients
receiving chemotherapy Colodny et al. [30] showed that
LRT improved fatigue, nausea, diarrhea, impaired taste,
constipation, insomnia and other quality of life indicators.
NT Factor® has been used in a study with severe
chronic fatigued patients to reduce their fatigue [26]. We
found that fatigue was significantly reduced from severe
to moderate fatigue, after eight weeks of LRT supple-
mentation with NT Factor® [26]. We also examined the
effects of NT Factor® on fatigue in moderately and mildly
fatigued subjects and determined if their mitochondrial
function improved with administration of NT Factor®
[28]. Use of NT Factor® for 12 weeks resulted in 35.5%
reduction in fatigue (P < 0.001). In this clinical trial there
was good correspondence between reductions in fatigue
and gains in mitochondrial function. After 8 weeks of
LRT with NT Factor®, mitochondrial function was sig-
nificantly improved (P < 0.001), and after 12 weeks of
NT Factor® supplementation, mitochondrial function was
found to be similar to that of young healthy adults [28].
After 12 weeks of supplement use, subjects were placed
on placebo without their knowledge for an additional 12
weeks, and their fatigue and mitochondrial function were
again measured. After the 12-week placebo period fa-
tigue and mitochondrial function were intermediate be-
tween the initial starting values and those found after
eight or 12 weeks on supplement, indicating that contin-
ued supplementation is likely required to show improve-
ments in mitochondrial function and to maintain lower
fatigue scores [28]. Similar results were found with chro-
nic fatigue syndrome and/or fibromyalgia syndrome pa-
tients [20]. Thus the results were similar to those found
here for CFS/ME, Lyme disease, fibromyalgia syndrome
and Gulf War illness patients.
Here we used a supplement preparation containing NT
Factor®, CoQ10 and microencapsulated NADH. Prior
studies reported that microencapsulated NADH alone had
a positive effect on fatigue in some patients. Analysis of
those studies indicated that a subset of patients responded
or the response was for a limited time. In the randomized,
cross-over study of Forsyth et al. [32] on CFS/ME pa-
tients 8 of 26 (30.7%) responded to microencapsulated
NADH compared to 2 of 26 (8%) on placebo (P < 0.05).
However, these results were not considered significant by
others [33,34]. When Santaella et al. [35] compared the
effectiveness of oral NADH versus a combination of
psychological/nutritional therapy for 31 CFS/ME patients
during a 24-month clinical trial, they found that NADH
demonstrated a reduction in fatigue in the first trimester
of the trial. In subsequent trimesters, symptom scores were
similar in NADH and psychological/nutritional therapy
arms of the trial. In another study oral NADH was given
for two months to CFS/ME patients. While the NADH
group showed a decrease in anxiety and maximum heart
rate after a stress test, differences were not found in the
functional impact of fatigue, quality of life, sleep quality,
exercise capacity or functional reserve between the test
and placebo group [36].
NADH is an important cofactor that is required in
many cellular enzyme pathways, including those involv-
ing certain transferases, polymerases, synthases, deacety-
lases and other enzymes [37]. It is also important in sig-
nal transduction, DNA repair, salvage pathways and post-
translational protein modifications [38]. NADH in its re-
duced form is a product of the mitochondrial electron
transport chain, and it plays an important role in pro-
grammed cell death [39]. Thus the NAD+/NADH system
has a major physiological impact on cellular health and
metabolism [40]. When mitochondria are functioning pro-
perly, enough NADH is produced to meet cellular re-
quirements [39].
CoQ10 is an essential electron carrier in the mitochon-
drial respiratory chain and an important antioxidant as
well as a molecule involved in gene regulation [41,42]. It
has been used as an important supplement in a variety of
chronic illnesses and age-related conditions [42-44]. Here
CoQ10 was used to improve energy transduction and com-
bat oxidative stress [42,45]. This cofactor has been used
extensively for combined nutraceutical therapy in mito-
chondrial cytopathies [45,46].
The present study used a combination nutraceutical
formulation containing NT Factor®, CoQ10 and NADH
and included a variety of chronic illness patients who had
been sick with chronic fatigue for an average of over 17
years. Chronic fatigue is known to cause loss of mito-
chondrial function [28,46]. These patients had tried a
large number of supplements and drugs (over 35) with
little or no effect on their fatigue. Thus this sample of pa-
tients could be considered as having intractable fatigue,
yet they responded quite well to the combination sup-
plement containing NT Factor®, CoQ10 and NADH. In
addition, regression analysis indicated that the data were
consistent with a high degree of confidence. The regres-
sion analysis also suggested that the trial may have ended
too soon, and the peak benefits on fatigue were yet to be
realized. The supplement was safe, and only two partici-
pants experienced minor symptoms that resolved after the
supplement was discontinued and could not be directly
attributed to the effects of the test supplement since their
problems preceded entry into the trial. Thus the clinical
trial demonstrated that the test supplement was effective
and safe for long-term chronic illness patients.
5. Conclusion
After 60 days use of a supplement containing a mixture
of phosphoglycolipids, CoQ10 and NADH, fatigue meas-
Copyright © 2012 SciRes. IJCM
Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly
Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients 169
ured with the validated Piper Fatigue Scale was signifi-
cantly reduced in 58 patients with chronic fatigue syn-
drome/myalgic encephalomyelitis, chronic Lyme disease
or other fatiguing illnesses, such as fibromyalgia syn-
drome or Gulf War illness. The supplement was safe and
effective and reduced overall fatigue 30.8% in these long-
term patients with intractable chronic fatigue.
6. Acknowledgements
The authors would like to thank Researched Nutritionals,
Inc. and the Institute for Molecular Medicine for clinical
trial financial support.
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