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Medical Food Classification Sentra AM ™ is a Medical Food formulated by practicing physicians to meet the nutritional requirements of patients who need to improve cognitive function and memory, achieve mental arousal, and maintain mental alertness. Sentra AM ™ provides the nutrients to support acetylcholine production by neurons. Acetylcholine is the important neurotransmitter supporting cognitive function, mental arousal, and memory. Under the regulations of the Food and Drug Administration, Medical Foods can only be used when a patient is under the ongoing care of a physician or other healthcare provider. Medical Foods are used for the management of disease states with known nutritional deficiencies. Medical Foods must contain ingredients found in the human diet and cannot be sold directly to patients without the supervision of a healthcare professional. Distinctive Nutritional Deficiencies Associated with Cognitive Disorders Choline deficiency is associated with liver disease and cognitive disorders. The Institute of Medicine recommends at least 500 mg of choline per day for adults. Although choline deficiency is associated with cognitive and memory abnormalities in humans, the amounts of choline required to maintain cognitive function in humans must be individualized. An individual physician must assess the role of choline deficiency in cognitive disorders in individual patients. Indications for Use
Neurotransmitter Production in the Human Body by Sentra AM ™
Targeted Cellular Technology This unique five-component process allows milligram quantities of neurotransmitter precursors to enter the cells and produce the required neurotransmitters. This process includes a neurotransmitter precursor, an uptake stimulator, a neuron activator, an adenosine brake inhibitor, and attenuation releaser. Previous attempts to use neurotransmitter precursors have required much larger quantities of the precursors to elicit a therapeutic effect making it functionally impossible for a patient to ingest large gram quantities of a precursor agent on a daily basis. The use of the Targeted Cellular Technology process also prevents the development of tolerance. Unlike pharmaceutical agents that lose their effectiveness in a relatively short period, Sentra AM ™ maintains its effectiveness and does not attenuate. Sentra AM ™ Ingredients: Targeted Cellular Technology and Sentra AM ™ Sentra AM ™ is designed to produce the neurotransmitter acetylcholine. Acetylcholine is the body's most important neurotransmitter and functions in all aspects of the autonomic nervous system. Acetylcholine is the neurotransmitter for the post-synaptic ganglion of the autonomic nervous system and is the neurotransmitter for the presynaptic ganglion of both the sympathetic and parasympathetic nervous systems. The terminal nerve roots of the neurons that control muscle contraction depend on acetylcholine; a deficiency of acetylcholine leads to muscle fatigue. Moreover, memory depends on acetylcholine production in the hippocampus. Arousal and alertness depends on acetylcholine function in the prefrontal cortex. Sentra AM ™ is designed to increase and maintain the production of acetylcholine by peripheral neurons and brain cells. Sentra AM ™ contains choline and acetylcarnitine as precursors to acetylcholine production. Choline is an essential amino acid and choline deficiency leads to a number of disease states. The FDA allows a health claim for choline in the prevention of certain forms of liver disease. It is well recognized that defects of acetylcholine function are part of a number of disease states including Alzheimer’s disease, vascular dementia, chronic fatigue, memory disorders, neurotoxicity related to pesticides and heavy metals and other environmental toxins. Sentra AM ™ is designed to support the production of acetylcholine. Sentra AM ™ and Clinical Testing Significant physiologic testing has been performed on patients both before and after taking Sentra AM ™ to measure parasympathetic function and circadian variations in sleep and wake patterns. Patients with symptoms of chronic fatigue and fibromyalgia show reduced parasympathetic function and reduced concentrations of choline in the brain. There have been open label trials of Sentra AM ™ in normalizing parasympathetic nervous system function. These studies used analysis of heart rate variability, PET scans, and spectral MRI data to demonstrate reduced choline function prior to treatment. Sentra AM ™ Dosage Sentra AM ™ is intended to be given daily in the morning. The usual dose of Sentra AM ™ is two capsules. An additional dose can be used during the day if fatigue continues or returns. As with all Medical Food products, the best dosing protocol is established by the healthcare provider in coordination with the requirements of each individual. Sentra AM ™ and Prescription Drugs Side Effects The side effect profile of Sentra AM ™ is comparable to the rate of food intolerance in the community. The ingredients of Sentra AM ™ are derived from nutrient based compounds found in the normal food chain. Food intolerance is an adverse reaction to food that does not involve the body's immune system. When first starting any amino acid therapy, some people complain of mild headaches, stomach upset, or mouth dryness. These symptoms are mild and temporary and can be managed by drinking plenty of fluids and carefully titrating the dose. Rarely, some individuals feel jittery or over-stimulated. These side effects are relieved by lowering the dose. Background Sentra AM ™ contains a blend of selected GRAS (generally regarded as safe) ingredients that are found in the normal human food chain. The primary ingredients are key amino acids, the building blocks of proteins. Sentra AM ™ is designed to induce increased neurotransmitter function associated with mental arousal, mental alertness, improved cognition, and memory. Sentra AM ™ increases the function of the neurotransmitters acetylcholine and glutamate. The Sentra AM ™ formula is based on a five-component patent pending process that allows for the conversion of a precursor into a neurotransmitter. The five component system includes the following: (1) amino acid precursors, (2) stimulation of the uptake of the precursor to initiate conversion to a neurotransmitter, (3) an adenosine antagonist such as caffeine or cocoa powder is added to disinhibit the neuron, (4) stimulation of neurons to release a specific neurotransmitter, and (5) a system to prevent attenuation of the precursor response. Sentra AM ™ has been formulated to encompass this five-component system. The Sentra AM ™ formula targets the neurotransmitters acetylcholine and glutamate. Sentra AM ™ is designed to produce two neurotransmitters acetylcholine, and glutamate. The two neurotransmitters are involved in mental arousal(1-50), mental alertness(51-99), memory(100-153), cognition and concentration(114;154-181). A disorder of acetylcholine metabolism is associated with Alzheimer’s Disease(182-215) and other dementias(191;216-249). Pharmaceutical approaches to treatment of Alzheimer’s disease have focused on inhibiting the breakdown of acetylcholine. The Institute of Medicine(250), that sets dietary recommendations for nutrients, has recommended that choline be defined as an essential nutrient with a minimum ingestion of 500 mg per day and health claims for choline administration be defined. The FDA has recently agreed to this recommendation and approved an initial health claim for choline in liver disease http://www.fda.gov/ohrms/dockets/dockets/dockets.htm, The Institute of Medicine recommends that adults, particularly during pregnancy, consume at least 500 mg per day of choline. Low fat/low protein diets do not provide 500 mgs of choline per day. Patients who do not consume eggs or a full glass of milk per day usually do not ingest 500 mgs per day of choline. In the Sentra AM ™ formula, Ginkgo Biloba is used as an uptake stimulator(251-256). Glutamic acid is used to produce glutamate, a neuronal stimulator(257-288). Cocoa is used to disinhibit the adenosine break(289-299) (300-303). Grape seed extract, containing polyphenols(304-307), is used to avoid the attenuation usually associated with neurotransmitter precursor administration. In order to test the effects of Sentra AM ™ on acetylcholine metabolism, heart rate variability testing from high resolution 24-hour ECG recordings was performed before and after Sentra AM™ use. These studies were performed in patients who had a fibromyalgia like syndrome associated with exposure to an environmental toxin. The defect in parasympathetic function was established by using quantitative audio vestibular testing. The patients were then studied in a double-blind manner with high resolution PET scanning and quantitative spectral MRI that could measure brain choline and glutamate concentrations in the human brain. The control group included patients from the same community who were not exposed to the toxic agent. The brains of patients exposed to the toxin exhibited abnormal PET scans. These abnormalities were located at the origin of the vagus nerve, the hypothalamus, and cerebellar-midbrain connections. These same areas of the brain exhibited reduced concentrations of both choline and glutamate.
These patients exhibited reduced parasympathetic activity as measured by spectral analysis of heart rate variability. This measurement is directly related to parasympathetic activity. In open label trials, the patients' symptoms of fatigue, temperature dysregulation, memory dysfunction, cognitive function, and concentration improved. Parasympathetic function returned toward normal.
The improvement in acetylcholine dependent parasympathetic function has been maintained for more then two years. Nutritional Deficiency of Choline The FDA has approved the recommendations of the Institute of Medicine to establish criteria for choline deficiency. Chronic fatigue and dementias have been associated with relative choline deficiency and abnormal acetylcholine metabolism. Nutritional Deficiency Associated with Cognitive Disorders Choline deficiency is associated with liver disease and cognitive disorders (104;308-357). The Institute of Medicine recommends an intake of at least 500 mg of choline per day for adults. Although choline deficiency is associated with cognitive and memory abnormalities in animals, the amounts of choline required to maintain cognitive function in humans is unknown and must be individualized for each patient. © 2006 Physician Therapeutics LLC & Nationwide Medical Foods
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Sentra AM ™ Product Information
