Safety and Efficacy Study of N‐SORB® a Proprietary KD120 MEC Metabolically‐ Activated Enzyme Formulation: A Randomized, Double‐blind, placebo Controlled Study

Abstract

BackgroundEnzymes are crucial for all aspects of metabolic function. Digestive enzymes from natural sources have been credited with beneficial effects in the digestion and absorption of food. N‐SORB is a novel KD120 multienzyme complex (MEC) of metabolically activated enzymes composed of proteases, amylases, lipases, alpha galactosidase, and glucoamylase from natural sources. These enzymes are encapsulated in an SK713 SLP (non‐GMO soy lecithin phospholipid) absorption technology (‘Prodosome®’).ObjectiveThis randomized double‐blind placebo‐controlled investigation assessed the safety and efficacy of Prodosomed N‐Sorb KD120 MEC on various parameters of the blood, immunity, body composition, physical health, and quality of life in young healthy male and female subjects over a 90‐day period.MethodsInstitutional Review Board Approval was obtained from University of Wyoming School of Pharmacy, Laramie, WY. Forty‐six young male and female (mean age: 25.8 ± 12.1 years) healthy volunteers, were randomly assigned to receive either N‐SORB (1 mL, twice daily) or placebo over a period of 90 consecutive days. Complete blood count as well as blood glucose, liver enzymes, and lipid profile were assessed pre‐ and post‐intervention. Serum cytokine levels were determined by using a Bio‐Plex Pro Human Cytokine 8‐plex Assay. Whole body composition analysis was performed by dual‐energy X‐Ray absorptivity (DEXA) to determine body fat mass, lean mass and android and gynoid fat. Body, weight, blood pressure, and physical health were assessed. WHOQOL‐BREF and a Pittsburgh Sleep Quality Index (PSQI) questionnaires were used for quality of life and sleep quality assessments respectively. Adverse events were monitored before, during and after the completion of the study.ResultsOf the 46 subjects enrolled, 41 subjects successfully completed the trial. Compared to placebo, changes in blood cell counts including hematocrit, hemoglobin, mean corpuscular volume, platelets and lymphocytes provide evidence of consistent improvement, which were reconfirmed by Quality of Life (QOL) parameters that significantly improved in the N‐SORB group. No significant changes in BUN, serum creatinine, ALP, AST, ALT, and lipid profile were observed between the placebo and treatment groups. No adverse reports were reported.ConclusionThis randomized, double blind, placebo‐controlled clinical study demonstrates that short‐term intervention with N‐SORB improves the QOL in young healthy volunteers and didn't alter cardiometabolic parameters, lipid profile or body composition. Subjects receiving N‐SORB reported an overall improvement in quality of life.Support or Funding InformationThe Study was Partially Supported by VNI Inc, Lederach, FLThis abstract is from the Experimental Biology 2019 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.