A short term pilot open label study to evaluate efficacy and safety of LG839, a customized DNA directed nutraceutical in obesity: Exploring Nutrigenomics

Kenneth Blum, Thomas J.H. Chen, Lonna Williams, Amanda LC Chen, William B. Downs, Roger L. Waite, T. Huntington, Simon Sims, Thomas Prihoda, Patrick Rhoads, Jeffrey Reinking, Dasha Braverman, Mallory Kerner, Seth H. Blum, Brien Quirk, Eric R. Braverman

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

We hypothesized that genotyping certain known candidate genes would provide DNA-individualized customized nutraceuticals that may have significant influence on body re-composition by countering various genetic traits. It is well known that obesity and related symptoms significantly aggravates type 2 diabetes. Both obesity and diabetes are influenced by the interaction of both genes and environmental factors. Exploration of the current literature has identified a number of candidate genes to be associated with both of these two disorders and include amongst others the dopamine D2 receptor (DRD2), methylenetetrahydrofolate reductase (MTHFR), serotonin receptor (5-HT2a), Peroxisome Proliferator-Activated Receptor gamma (PPAR-γ), and Leptin (OB) genes. In the present study, we systematically evaluated the impact of polymorphisms of these five candidate genes as important targets for the development of a DNA-customized nutraceutical LG839 [dl-phenylalanine, chromium, l-tyrosine other select amino-acids and adaptogens]) to combat obesity with special emphasis on body recomposition as measured by Body Mass Index (BMI). A total of 21 individuals were evaluated in a preliminary investigational study of LG839. Based on the results of buccal swab genotyping of each subject, an individualized customized nutraceutical formula was provided as a function of measured gene polymorphisms of the five gene candidates assessed. At the inception of the study and every two weeks subsequently, each subject completed a modified Blum-Downs OPAQuE Scale [Overweight Patient Assessment Questionnaire]. The alleles included the DRD2 A1; MTHFR C 677T; 5HT2a 1438G/A; PPAR-γPro12A1a and Leptin Ob1875<208bp. Pre- and post ad hoc analysis revealed a significant difference between the starting BMI and the BMI following an average of 41 days (28-70d) of LG839 intake in the 21 individuals. The pre- BMI was 31.2 (weight/Ht2) compared to the post BMI of 30.4 (weight/Ht2) with a significance value of P < 0.034 (one tailed). Similarly the pre -weight in pounds (lb) was 183.52 compared to the post weight of 179 lb with a significance value of P<(0.047). We also found trends for reduction of late night snacking, carbohydrate craving reduction, reduction of stress, reduction of waist circumference. Moreover, in the 41 day period we found a trend in weight loss whereby 71.4% of subjects lost weight. Thus 15 out of 21 subjects lost weight with a z score of 2.4 and significance value of P <(0.02). In this group 53% lost on average over 2.5% of their starting weight. Further confirmation of these preliminary results (ongoing) warrants investigation and should ultimately provide novel DNA directed "omic" therapeutic targets of novel anti-obesity agents especially in diabetes and other related diseases.

Original languageEnglish (US)
Pages (from-to)371-382
Number of pages12
JournalGene Therapy and Molecular Biology
Volume12
Issue number2
StatePublished - Dec 1 2008

Keywords

  • Diabetes
  • Genes
  • LG839
  • Nutrigenomics
  • Obesity
  • Polymorphisms
  • Reward deficiency syndrome (RDS)
  • Synaptamine™

ASJC Scopus subject areas

  • Molecular Medicine
  • Molecular Biology

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    Blum, K., Chen, T. J. H., Williams, L., Chen, A. LC., Downs, W. B., Waite, R. L., Huntington, T., Sims, S., Prihoda, T., Rhoads, P., Reinking, J., Braverman, D., Kerner, M., Blum, S. H., Quirk, B., & Braverman, E. R. (2008). A short term pilot open label study to evaluate efficacy and safety of LG839, a customized DNA directed nutraceutical in obesity: Exploring Nutrigenomics. Gene Therapy and Molecular Biology, 12(2), 371-382.