Early Results from the D.I.E.T. Study (Phase 1) Suggest that DNA-Customized GenoTrim Ingredient May Lower Fat and Body Weight

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Salugen researchers present data at the Annual Meeting of the National Nutritional Foods Association suggesting that consumers tested with the "Sweet Tooth Gene" (Dopamine D2 Receptor Gene) can benefit for DNA-Customized GenoTrim.

The effectiveness of chromium picolinate (CrP) in altering body composition has been controversial. Evidence from this multi-centered study may provide a functional basis linking dopaminergic gene polymorphisms first to percent body fat and obesity and secondarily to the nutrigenomic response of CrP in producing body composition effects.

Salugen, Inc., a leader in personalized healthcare, presented early findings from the D.I.E.T. Study (Dutch Investigation to Evaluate Treatments of DNA-Customized Nutritional Solutions for Weight Management) this past weekend at the annual meeting of the National Nutritional Foods Association (NNFA) in Las Vegas, during the scientific poster session on Friday afternoon. This data suggests that consumers with the “Sweet Tooth Gene” are 1.4 times more likely to suffer from weight problems and those consumers may benefit from DNA-customized GenoTrim (http://www.genotrim.com).

In a study of 901 subjects entitled, “Dopamine D2 receptor gene polymorphisms are significantly associated with percentage body fat and obesity in the D.I.E.T. Study: a functional basis for the nutrigenomic response of chromium picolinate (CrP) in producing body composition effects,” Salugen Chief Scientific Officer and Adjunct Professor at Wake Forest University School of Medicine, Dr. Kenneth Blum, presented early findings suggesting the need to genotype obese subjects for the “Sweet Tooth Gene” (Dopamine De Receptor Gene) prior to chromium picolinate nutritional supplementation as a treatment modality resulting in weight loss.

“Over the past thirty years, we have conducted studies providing evidence correlating dopaminergic genes and obesity, body mass index (BMI), body type, overeating, carbohydrate binging, and low dopamine D2 receptor (D2R) density,” says Dr. Blum. “But there are few studies involving the dopamine d2 receptor gene (DRD2) variants and percentage body fat.” Salugen has a DNA-customized nutritional solution for weight management, GenoTrim, which analyzes a panel of genes and based upon those genes, provides a nutritional supplement targeted to the individual. One of those genes in the GenoTrim panel is the “Sweet Tooth Gene” (Dopamine D2 Receptor Gene A1 and A2 allele).

Dr. Blum goes to explain, “The effectiveness of chromium picolinate (CrP) in altering body composition has been controversial. Evidence from this multi-centered study may provide a functional basis linking dopaminergic gene polymorphisms first to percent body fat and obesity and secondarily to the nutrigenomic response of CrP in producing body composition effects.” GenoTrim includes chromium picolinate (CrP) that is included and dosed based an individual’s genetic profile.

In this multi-centered study, a total of 901 subjects were genotyped for the “Sweet Tooth Gene” (A1 and A2 allele). A total of 257 subjects were assessed for weight, BMI (kg/m2) and percent body fat using dual energy X-ray absorptiometry (DEXA). The remaining 644 subjects were part of the D.I.E.T. study and were assessed using a questionnaire. In the first population, the “Sweet Tooth Gene” (A1 allele) was present in 67% of the obese subjects compared to 3.3 % of the well-screened controls A and 33.3 % for controls B. These differences were significant: Controls A vs. Obese subjects: (r2 = 39.6, df =1, p value less than 0.0001), and Controls B vs. Obese subjects (r2 = 25.9, df = 1, p value less than 0.0001). With regard to the effects of CrP, the measurable change in fat weight (p value less than 0.041), body weight (p value less than 0.017), percent change in weight (p value less than 0.044), and body weight change in kilograms (p value less than 0.012) were all significant for carriers of the “Sweet Tooth Gene” (A2 allele). No significance was found for any parameter for those subjects possessing a DRD2 A1 allele. In terms of the role of dopamine in global obesity, the “Sweet Tooth Gene” (A1 allele) was present in 37% of the self identified obese subjects in the D.I.E.T. study. Compared to literature controls (N=3,329), a significant association was found (X2 14.47; df=1, p value less than 0.0001, OR = 1.407, 95% CI).

Salugen CEO Brian Meshkin states, “This data from leading researchers at Wake Forest University School of Medicine, Brooklyn College CUNY, University of Texas Health Science Center, City of Hope National Medical Center, Path Medical Research Foundation, and others continues to demonstrate the important contribution of Salugen’s scientific and rational approach to nutrition.” Meshkin goes onto to say, “If we can test people for the genes that make them prone to experiencing weight problems, then we can start to address the underlying factors to reduce their weight and the associated problems of diabetes, heart disease, and arthritis. This is another example of clinical data supporting GenoTrim and we look forward to further publications supporting the important need to address the genetic factors involved in weight and many other healthcare concerns.”

About GenoTrim

GenoTrim is a DNA-customized nutritional solution for weight management. Based upon an analysis of five important genes effecting weight, GenoTrim ingredients and dosages are genetically-guided to address the underlying genetic factors involved in hormones and metabolism that Harvard Medical Experts suggest influence 70% to 80% of overweight cases. By addressing genetic factors that make individuals prone to weight problems, GenoTrim supports healthy sleep, digestion, mood, and fat metabolism which results in sustainable weight loss and overall trimming. GenoTrim was unexpectedly test launched in The Netherlands in early 2006 and will be available in the United States in the second half of 2006. For more information on GenoTrim, please visit http://www.genotrim.com.

About Salugen

Salugen, Inc., a leading personalized healthcare company, engages in the discovery, development and commercialization of patent-protected genetic tests and companion DNA-customized therapeutics worldwide. With over 30 years of research conducted on the genetic causes and pharmacology of many healthcare concerns, Salugen is a pioneer and leader in delivering personalized medicine. Currently, the Company commercializes nutrigenomic technologies where genetic analysis guides the formulation and delivery of nutritional solutions that are customized to the individual. The company has headquarters in San Diego, CA, with its high-complexity CLIA-certified laboratory services in Los Angeles, CA. For additional information about the company, please visit http://www.salugen.com.

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