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INTRODUCTION TO THE RESEARCH
Introduction
All of our cells depend on cellular membranes to enclose cells and
compartments within cells and provide cells with the ability to make and
assemble proteins and enzymes and the components that generate cellular
energy (the mitochondria). They also maintain the organization of our
genetic information (the nucleus). Mitochondria are the little batteries
inside our cells that produce 90% of the energy needed for cellular
activities and synthesis of cellular molecules. However, mitochondria
are particularly sensitive to membrane damage that occurs during aging
and disease. When their membranes are damaged, such as during disease,
mitochondria cannot provide the energy necessary for natural cellular
functions. The membrane lipids of mitochondria, called phospholipids,
are particularly sensitive to this type of damage, and they must be
repaired to return mitochondria and cells to normal function and
maintain general health.
Membrane Lipid Replacement (MLR) is the oral supplementation of membrane
phospholipids, along with protective molecules and antioxidants to
provide membrane replacement molecules for those that are damaged during
chronic illnesses, cancer and aging [1,2]. Replacement membrane
phospholipids are important for a variety of cellular and tissue
functions. They repair damage to mitochondrial membranes, and are also
an important energy storage reservoir and provide precursors for
bioactive molecules that function in cellular signaling and molecular
recognition pathways. Thus MLR lipids are considered essential for
general health [1-5].
We have used MLR with oral phospholipid supplements to successfully
reduce fatigue in Chronic Fatigue Syndrome (CFS) and Fibromyalgia
patients [1,2]. More recently we have found in uncontrolled preliminary
studies that the MLR phospholipids (4 g per day) can reduce pain as well
as gastrointestinal symptoms in a few self-reporting Fibromyalgia
patients (6). These results, those from several published trials and
other preliminary observations on a few Fibromyalgia patients form the
basis for this clinical study to use special phospholipid wafers to
assess their ability to reduce pain, fatigue and gastrointestinal
symptoms and improve Quality of Life (QOL) indicators in Fibromyalgia
patients.
The Clinical Study
The goals of this clinical study are to test the ability of the membrane
phospholipids to reduce pain, fatigue and gastrointestinal symptoms
while improving indicators for quality of life in adult male and female
Fibromyalgia patients. Using a randomized, double-blinded,
placebo-controlled, cross-over clinical trial format we will test the
outcome (symptoms and QOL) in Fibromyalgia patients taking oral membrane
phospholipid (test supplement) wafers over 6 week periods of test
supplement and placebo (control wafers that look and taste the same but
without the active ingredient phospholipids). A randomized,
double-blinded, placebo-controlled study means that patients will be
placed randomly into two groups and neither the patients or the
investigators will know which group. One group will first take the
phospholipid wafers for approximately 6 weeks, stop for two weeks, and
then take placebo wafers for approximately 6 weeks. The other group will
start with the placebo wafers, stop for two weeks, and then take the
test phospholipid wafers for 6 weeks. At various times, patients will be
asked to evaluate their symptoms using a Combined Symptoms Survey Form
that will document their symptom severities at different times. In this
type of study every patient will receive the same test and placebo
supplements, but at different times unknown to them and to the trial
investigators. In this way the severity of symptoms can be directly
linked to the test supplement and not due to a random feeling that the
test supplement is working to reduce symptom severity. The entire study
will take approximately 3 months to complete.
Significance of the Clinical Study
The most characteristic feature of Fibromyalgia is widespread chronic
pain, and this has resulted in the increased use of various methods of
pain control, mainly opioids and other pharmaceuticals [7, 8]. Recently
the long-term use of opioids for pain control in Fibromyalgia patients
has been questioned. Evidence from several sources, including controlled
clinical trials, indicates that there is only a weak connection between
opioids and their ability to reduce pain during long-term treatment in
Fibromyalgia [9].
Similarly, long-term use of pharmaceuticals to control fatigue in
Chronic Fatigue Syndrome and other conditions have also been questioned.
The use of natural supplements, including MLR with oral phospholipid
supplements, to provide mitochondrial support has also been reviewed
with some positive results noted by investigators [10]. Thus there is
evidence to support the use of a new approach in the treatment of pain,
fatigue, gastrointestinal and other symptoms in Fibromyalgia patients.
Safety of the Test Phospholipid Supplement
Preclinical and clinical studies on the phospholipid test supplement
have not shown any evidence of toxicity, including high dose effects on
adults, effects on unborn or newly born and older children as well as
the ability to cause cancers [1,2]. Thus there has been no indication
that would indicate any possible risk in ingesting the phospholipid
supplements. None of the preclinical studies, which were mostly
conducted in laboratory animals (mice, rats and rabbits), have
demonstrated any acute or chronic toxic effects of phospholipids given
by oral, subcutaneous or intravenous administration [1]. In addition,
multiple studies on toxic or lethal doses could not establish in
laboratory animals any toxic or lethal dose levels of MLR supplements.
Over 40 million doses of the test phospholipid supplement have been
consumed by adults and children without any evidence of adverse effects.
References
1. Nicolson GL, Rosenblatt S, Ferreira de Mattos G, Settineri R,
Breeding PC, Ellithorpe RR, Ash ME. Clinical uses of Membrane Lipid
Replacement supplements in restoring membrane function and reducing
fatigue in chronic diseases and cancer. Discoveries 2016; 4(1): e54.
2. Nicolson GL. Membrane Lipid Replacement: clinical studies using a
natural medicine approach to restoring membrane function and improving
health. Intern. J. Clin. Med. 2016; 7: 133-143.
3. Nicolson GL. Lipid replacement therapy: a nutraceutical approach for
reducing cancer-associated fatigue and the adverse effects of cancer
therapy while restoring mitochondrial function. Cancer Metastasis Rev.
2010; 29(3), 543-552.
4. Küllenberg D, Taylor LA, Schneider M. Massing U. Health effects of
dietary phospholipids. Lipids Health Dis. 2012; 11: e3.
5. van Meer G, Voelker DB, Feigenson GW. Membrane lipids: where they are
and how they behave. Nat. Rev. Mol. Cell Biol. 2008; 9: 112-124.
6. Nicolson GL, Breeding PC. Membrane Lipid Replacement with
glycerolphospholipids to restore mitochondrial function and reduce
fatigue and pain in CFS/Me and Fibromyalgia patients. Fibromyalgia 2016.
Abstract.
7. Painter IT, Crofford LI. Chronic opioid use in fibromyalgia syndrome:
a clinical review. J. Clin. Rheumatol. 2013; 19: 72-77.
8. Provenzano DA, Viscusi ER. Rethinking the role of opioids in the
outpatient management of chronic nonmalignant pain. Curr. Med. Res. Opin.
2014; 30: 2051-2062.
9. Goldenberg DL, Clauw DJ, Palmer RE, Clair AG. Opioid use in
Fibromyalgia: a cautionary tale. Mayo Clin. Proc. 2016; 91(5): 640-648.
10. Nicolson GL. Mitochondrial dysfunction and chronic disease:
treatment with natural supplements. Altern. Therap. Health Med. 2014;
20(suppl 1): 18-25.
INFORMATION ON THE CLINICAL STUDY
INTRODUCTION TO THE RESEARCH
THE TEST SUPPLEMENT
PRIVACY AND INFORMED CONSENT
FREQUENTLY ASKED QUESTIONS AND ANSWERS
THE INVESTIGATORS
SIGN UP FOR THE CLINICAL STUDY
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