Salugen's clinical trials are crucial to the exploration of new DNA-Customized Nutritional Solutions that may address significant unmet medical needs. Salugen places a high priority on communicating information about studies that are currently enrolling as well as on ensuring that clinical trial results for completed studies for marketed products are available to physicians and other interested parties. In 2007, Salugen will invest 20% of net sales into research and development – far more than any other nutritional company and on par with the leading pharmaceutical and biotechnology companies.
The following outlines some of the studies that Salugen has planned:
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Product:
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GENOTRIM
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Type of Study:
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P.A.T.H. Study - Prospective Analysis of Total Health Improvement on GenoTrim
90-Day observational trial
Currently enrolling
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Estimated Begin/End Date:
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August 2007 to December 2007
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Projected Measurements:
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150 patients receiving the GenoTrim DNA Test and customized nutritional solution
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Genetic analysis of MTHFR C677T, DRD2 Taq 1 allele, 5-HT2A Receptor, PPAR-Gamma, Leptin OB
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Survey questionnaire every two weeks for 90-days to measure height, weight, body changes, cravings, appetite, sleep, and other parameters
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Product:
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SpaGen
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Type of Study:
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P.E.A.C.E.F.U.L. E.S.C.A.P.E. Study - Psychodermatologic Evaluation of the Anti-Anxiety Response For Underlying Dermal Effects of the Synaptamine Complex, a Putative Dopaminergic Activator in SpaGen
A Randomized, Double-Blinded, Placebo-Controlled Study (n=50)
Currently enrolling
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Estimated Begin/End Date:
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End date of October 2007
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Projected Measurements:
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- Skin Conductance Level (SCL) - The electrical properties of the skin have been widely utilized in the assessment of emotional response. This technique has proven quite reliable as a measure of stress levels in the patient (for example, extent of anxiety or anger). As such, this is an indirect measure of stress levels in the patient. The SCL, the inverse of the galvanic skin resistance (GSR), monitors absolute skin conductance level as measured in micromhos.55 A correlation exists between orienting and anxiety responses which by sympathetic activation results in increase in skin conductance. Thus, a decrease in conductance is associated with a decrease in autonomic arousal.
To make these measurements, an Autogen 3000 (Autogenic Systems) will be attached to the middle three fingers of the dominant hand of each patient, and a reading obtained. Measurements will be carried out approximately 16 times for each patient who completed treatment.
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Product:
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HAVEOS (synaptamine)
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Type of Study:
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Observational study of narcotic attenuation over 90 days
Currently enrolling
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Estimated Begin/End Date:
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September 2007 to December 2007
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Projected Measurements:
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HAVEOS Genes (DRD2, 5-HT2A, COMT Val158Met)
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Narcotic usage reduction
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Reward Deficiency Behaviors (RDS) behaviors such as changes in craving, anxiety, sleep, weight, etc.
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Product:
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GENOTRIM
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Type of Study:
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A.N.S.W.E.R. Study -
Analysis of Nutritional Supplements for Weight to Evaluate Response on DNA-customized GenoTrim
Randomized, placebo controlled trial
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Estimated Begin/End Date:
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September 2008 to September 2009
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Projected Measurements:
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