Medical Foods in Clinical Care

In the presence of disease or injury, the body’s requirements for nutritional components are changed. Each medical food used in the dietary management of a disease or injury contains the specific elements to stimulate the neurotransmitters related to that particular condition. Medical Foods are formulated to aid in the dietary management of a specific disease or condition that causes distinctive nutritional requirements that are different from the nutri-tional requirements of healthy people and are not able to be obtained from the normal diet alone. Medical Foods can be an integral compo-nent of the clinical management of patients with distinctive nutritional requirements caused by chronic disease, trauma, stress, genetics or prescription drugs.

Safe and Effective Therapies

  • Obesity Associated with Metabolic Syndrome Fatigue and Cognitive Disorder
  • Sleep Dysfunction Associated with Depression
  • Sleep Dysfunction Associated with Anxiety
  • Viral Infection and Impaired Immune Function
  • Fibromyalgia
  • Hypertension
  • Chronic Pain
  • Osteoarthritis
  • Peripheral Neuropathy

Targeted Cellular Technology®

Each Medical Food uses a patented five step process that increases the cellular uptake and utilization of neurotransmitter precursors.

Clinical Trials and Peer Reviewed Nationally Recognized Data

Targeted Medical Pharma's product development is validated by the evidence based review system for the scientific evaluation of health claims established by the FDA. Every therapeutic system Targeted Medical Pharma develops is formulated utilizing ingredients that are Generally Recognized as Safe (GRAS). Each medication is manufactured in a cGMP certified facility in accordance with the FDA’s medical food compliance manual. The efficacy of each Medical Food is supported by clinical evidence derived from well-designed trials conducted in a manner which is consistent with generally recognized scientific procedures and principles.

Clinical Trial Overview

Theramine®
  • "A Double Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain". American Journal of Therapeutics, 2012
  • "Theramine (a medical food) versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients: A Pharmacoeconomic Analysis." Silver et al. Journal of Pharmacy Research, 2012.
  • "Theramine vs. lbuprofen for the safe and effective management of chronic low back pain and inflammation." A double blind multi-center controlled trial. Painweek Poster 2012, AMSUS Poster 2012, Publication Pending.
  • A randomized double blind placebo controlled trial to determine the status of post knee chondroplasty patients administered Theramine vs. Placebo in addition to post
  • Multiple open label clinical crossover trials measuring a reduction in pain as an endpoint.
Sentra PM®
  • "Sentra PM (a medical food) and Trazodone in the Management of Sleep Disorders". Shell et al. Journal of Central Disease, 2012
  • "Administration of an Amino Acid Based Regiment (Sentra AM and Sentra PM) for the Management of Autonomic Nervous System Dysfunction Related to Combat Induce Illness." Shell et al. 2012, Publication Pending.
  • Multiple open label clinical trials showing an increase in autonomic nervous system function including continual improvement after several months.
GABAdone®
  • "A Randomized, Placebo Controlled Trials of an Amio Acid Preparation (GABAdone) on Timing and Quality of Sleep." Shell et al. American Journal of Therpaeutics, 2009.
  • Multiple open label clinical trials in patients with sleep anomalies, measuring a decrease in sleep latency nighttimes awakenings and an increase in restorative sleep.
Sentra AM ®
  • "Administration of an Amino Acid Based Regiment (Sentra AM and Sentra PM) for the Management of Autonomic Nervous System Dysfunction Related to Combat Induce Illness." Shell et al. 2012, Publication Pending.
  • Open Label study of patients with Fibromyalgia, measuring improvement in HF band of parasympathetic activity who exhibited abnormal parasympathetic nervous system function at baseline.
  • Nursing assessment of patients in skilled nursing facilities prescribed Sentra AM, Sentra PM and Theramine for cognitive impairment, sleep disturbance and pain.
Hypertensa®
  • Multiple open label clinical outcomes trials measuring a decrease in systolic and diastolic blood pressure, increase in vascular impedance and a decrease in systemic vascular resistance.
  • Open label clinical study measuring an increase in nitric oxide production in expired air from baseline.
Apptrim®
  • "The Effect of AppTrim on Appetite Suppression, Weight Loss, and Reduction in Percent Body Fat, a Double Blind Placebo Controlled Study" Simpson et al. University of South Carolina. Exponenet Inc, 2007.
  • "A Double Blind Placebo Controlled Trial of the Effect of AppTrim on Appetite Suppression and Obesity Management." Shell et al. Targeted Medical Pharma Inc., 2008.
  • Multiple open label trials in obese patients, measuring a decrease in BMI, weight, appetite and carbohydrate cravings.

Neurotransmitters and Disease

Neurotransmitter depletion1 and the associated synaptic fatigue2 may contribute to chronic pain states. The neurotransmitter depletion results from an increase in neurotransmitter precursor turnover as well as dietary deficiency of the neurotransmitter precursor.3 The consequent reduced production of neurotransmitters contributes to maladaptive pain responses.

The ability to enhance neurotransmitter production associated with pain syndromes is limited by multiple factors, specifically unavailability of adequate essential amino acids in the diet and increased turnover rates of amino acids needed to produce neurotransmitters under such conditions.3 Other factors such as prolonged pharmaceutical use deplete the nerve cells of neurotransmitters.4

  • 1. Miyamoto H, Nakamaru-Ogiso E, Hamada K, Hensch TK. Serotonergic integration of circadian clock and ultradian sleep-wake cycles. J Neuosci 2012 October 17;32(42):14794-803.
  • 2. Wen G, Hui W, Dan C et al. THe effects of exercise-induced fatigue on acetylcholinesterase expression and activity at rat neuromuscular junctions. Acta Histochem Cytochem 2009 October 30;42(5):137-42
  • 3. Fernstrom JD. Effects and side effects associated with the non-nutritional use of tryptophan by humans. J Nutr 2012 December;142(12):2236S-44S
  • 4. Barton DA, Esler MD, Dawood T et al. Elevated brain serotonin turnover in patients with depression: effect of genotype and therapy. Arch Gen Psychiatry 2008 January;65(1):38-46

Identifying the Increased Nutritional Requirements of Pain Syndromes

Patients with pain syndromes show decreased levels the amino acids required for production of pain modulating neurotransmitters, dispite having a sufficient intake of protein, indicating that the need for these amino acids are selectively increased in these1 patients.

* Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in fibrositis/fibromyalgia syndroms. J Rheumatol Suppl 1989;19:158-163

**Shell et al. Theramine and Ibuprofen double blind clinical trial, 2010. Publication pending.

Theramine®: Improve Pain Management

Theramine is a medical food indicated for the dietary management of pain syndromes. It is a specialized formulation that provides the body with the precursors to the pain modulat-ing neurotransmitters serotonin, GABA, acetyl-choline, histamine and nitric oxide. Theramine utilizes Targeted Cellular Technology to maximize cellular uptake and utilization of mg amounts of free amino acids. Theramine is indicated for acute and chronic pain, fibromy-algia, neuropathic pain, and inflammatory pain.

Sentra PM®: Improve Restorative Sleep

Sentra PM is a medical food indicated for the dietary management of sleep disorders associated with depression. Sentra PM provides the body with the precursors to the neurotransmitters serotonin, GABA, acetylcholine, and glutamate. Sentra PM utilizes Targeted Cellular Technology to facilitate the uptake and utilization of amino acids to improve restorative sleep and autonomic nervous system function in patients suffering from depression, PTSD, or other autonomic disorders.

Medical Foods have been used in clinical practice since the 1950’s. These medications are regulated by the FDA and the Orphan Drug Act of 1988. Each Medical Food is composed of ingredients that are Generally Recognized as Safe (GRAS), and tested for efficacy using well designed double blind, multicenter trials.

Reduction of Pain-Roland Morris Index

Improvement in Quality of Sleep

Medical Food Prescribing Guidelines

Theramine®

Indication: For the dietary management of pain syndromes that include chronic pain, fibromyalgia, neuropathic pain, and inflammatory pain.

Suggested Dosing: Take two (2) capsules twice daily or as needed under physician supervision.

GABAdone®

Indication: For the dietary management of sleep disorders associated with anxiety.

Suggested Dosing: Take one (1) or two (2) capsules at bedtime to initiate sleep. Take one (1) or two (2) capsules during the night if awakened and cannot fall back to sleep, or as needed under physician supervision.

Sentra PM®

Indication: For the dietary management of sleep disorders associated with depression.

Suggested Dosing: Take one (1) or two (2) capsules at bedtime to initiate sleep. Take one (1) or two (2) capsules during the night if awakened and cannot fall back to sleep, or as needed under physician supervision.

Sentra AM®

Indication: For the dietary management of fatigue and cognitive disorders.

Suggested Dosing: Take two (2) capsules daily in the morning or as needed under physician supervision.

Trepadone®

Indication: For the dietary management of pain associated with osteoarthritis.

Suggested Dosing: Take two (2) capsules twice daily or as needed under physician supervision.

AppTrim®

Indication: For the dietary management of obesity associated with metabolic syndrome.

Suggested Dosing: Take two (2) capsules at mid-morning, Two (2) capsules at mid-afternoon or as needed under physician supervision.

Lister V®

Indication: For the dietary management of viral infection and impaired immune function.

Suggested Dosing: Take two (2) capsules four times daily in between meals or as needed under physician supervision.

Hypertensa®

Indication: For the dietary management of hypertension.

Suggested Dosing: Take two (2) or three (3) capsules twice per day or as needed under physician supervision.

Percura®

Indication: For the dietary management of pain, inflammation and loss of sensation due to peripheral neuropathy.

Suggested Dosing: Take two (2) capsules twice daily or as directed by physician.