Peripheral neuropathy is a disorder of the peripheral nerves—the motor, sensory and autonomic
nerves that connect the spinal cord to muscles, skin and internal organs. It usually affects
the hands and feet, causing weakness, numbness, tingling and pain. Peripheral neuropathy's
course is variable; it can come and go, slowly progressing over many years, or it can become
severe and debilitating. Peripheral neuropathy is common and it is estimated that upwards of
20 million Americans suffer from this illness. It can occur at any age, but is more common
among elderly patients. In l999, a survey found that 8-9% of Medicare recipients have
peripheral neuropathy as their primary or secondary diagnosis and the annual cost to Medicare
exceeds $3.5 billion. Approximately 30% of peripheral neuropathy cases are linked to
diabetes. Other common causes of neuropathy include autoimmune disorders, tumors, hereditary
conditions, nutritional imbalances, infections or toxins. Another 30% of peripheral
neuropathies are termed "idiopathic" when the cause is unknown. Pain in particular is a
complex process initiated by pain-inducing or noxious stimuli interacting with pain receptors
(nociceptors) which triggers a series of action potentials that are transmitted by
neurotransmitters from peripheral afferent neurons to the spinal cord and higher nerve
centers in the brain.
The study intervention is classified as a medical food that must be used under the active or
ongoing supervision of a physician. Medical foods are developed to address the different or
altered physiologic requirements that may exist for individuals with distinctive nutritional
needs arising from metabolic disorders, chronic diseases, injuries, premature birth
associated with inflammation and other medical conditions, as well as from pharmaceutical
therapies. All of the ingredients included in the study intervention are classified as
generally recognized as safe (GRAS) by the United States Food and Drug Administration (FDA).
To qualify for GRAS status, a substance that is added to a food, including a medical food,
has to be supported by data demonstrating that it is safe when consumed in amounts from these
foods, as they are typically ingested or prescribed.
The study intervention is a proprietary blend of amino acids and antioxidants designed to
target the cellular processes involved in the management of peripheral neuropathy symptoms.
All of the ingredients are supplied in small milligram quantities which allows for safe and
flexible dosing.
