N-Sorb Science

Safety and Efficacy of N-SORB®, a Proprietary KD120 MEC Metabolically Activated Enzyme Formulation: A Randomized, Double-Blind, Placebo-Controlled Study.Wang Q, Guo R, Nair S, Smith D, Bisha B, Nair AS, Nair R, Downs BW, Kushner S, Bagchi M.

Abstract:

Background:

Enzymes 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 a SK713 SLP (non-GMO soy lecithin phospholipid) absorption technology (Prodosome®).

Objective:

This randomized, double-blind placebo-controlled investigation assessed the safety and efficacy of N-SORB KD120 MEC in healthy male and female volunteers on various parameters of the blood, immunity, body composition, physical health, and quality of life following a 90-day intervention.

Methods:

Forty-six 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 for 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 and enzyme linked immunosorbent assay (ELISA). Whole body composition analysis was performed by dual-energy x-ray absorptiometry (DEXA) to determine body fat mass, lean mass, and android and gynoid fat. Body weight, blood pressure, and physical health were assessed. Changes in quality of life were examined using the World Health Organization Quality of Life-abbreviated version and sleep quality was assessed using the 24-item Pittsburgh Sleep Quality Index (PSQI) questionnaire. Adverse events were monitored before, during, and after completion of the study.

Results:

Of the 46 subjects enrolled, a total of 40 subjects successfully completed the study. Compared to placebo, changes in blood cell counts including hematocrit, hemoglobin, mean corpuscular volume, platelets, and lymphocytes provide evidence of some improvement. Quality of life (QOL) parameters showed a small but significant improvement in the N-SORB group. A significant increase was observed in aspartate aminotransferase level in the placebo group at the end of 90 days of treatment; however, no increase was observed in the N-SORB group. No significant changes in blood urea nitrogen, serum creatinine, alkaline phosphatase, alanine aminotransferase, and lipid profile were observed between the placebo and treatment groups before and following intervention. No adverse effects were reported.

Conclusions:

This randomized, double blind, placebo-controlled clinical study demonstrates that short-term intervention with N-SORB improves the QOL and PSQI in healthy volunteers and did not significantly alter cardiometabolic parameters, lipid profile, or body composition.

Key Points:

This is a follow-up evaluation on a previous study of 11 subjects from two independent clinics, suffering from a range of metabolic, neuro-immuno and GI tract related problems including leaky gut and gluten allergy.

➢ Physical Well-Being Significantly Improved

➢ Sleep Quality Dramatically Improved as demonstrated by the Pittsburgh Sleep Quality Index (PSQI)

➢ Energy Levels Improved

➢ Reduced Occurrence of Headache

➢ No Diarrhea

➢ Cardiovascular Health Improved

➢ Overall Lifestyle Quality Improved as exhibited by Quality of Life (QOL) and World Health Organization Quality of Life - abbreviated version (WHOQOL-BREF) Assessment

➢ Body Mass Index (BMI) reduced in N-SORB™ Treated Subjects

➢ LDL level showed an increasing trend in the placebo group, remained stable in Treatment Group

➢ Kidney, Cardiovascular and Hepatic Functions Improved

➢ Optimized Levels of Platelets and Lymphocytes

➢ Broad Spectrum Safety

Published Clinical Study (PUBMED)

LEDERACH, Pa., May 19, 2019 (Newswire.com)

Safety and efficacy of a novel KD120 MEC multi-enzyme complex (N-Sorb®) in human volunteersBernard W Downs, Steve W Kushner, Manashi Bagchi, Anand Swaroop and Debasis BagchiFASEB J. April 2017 31:lb312

Abstract:

Digestive enzymes have been historically consumed to enhance disintegration and dissolution of foodstuffs in the stomach. N-Sorb is a novel KD120 multi-enzyme complex (MEC) containing a range of protease, amylase, and lipase enzymes and including glucoamylase and alpha-galactosidase. Unlike conventional digestive enzymes, these enzymes are activated in pH environments ranging from 6.5 to 8.5. These enzymes are encapsulated in a patent-pending SK713 Soy Lecithin Phospholipid absorption technology (‘Prodosomes’) to facilitate rapid absorption and delivery into the blood, and increase availability to tissues. Eleven case studies from two independent clinics (one in California and one in Pennsylvania) are reported in this presentation under the strict supervision of two physicians. Eleven male and female volunteers (age: 20 to 71 years) suffering from gut related digestive problems including digestive dysfunctions and leaky gut, as well as gluten allergy, consumed a minimum of one dose (1/8 tsp Prodosomes and 1/8 tsp enzyme powder mixed into 4 ounces of water) two times per day on an empty stomach over different periods of time ranging from 1 month to 4 months. Subjects were compliant based on product usage and replacement. All subjects reported significant improvement in gastrointestinal functions among other systemic improvements. No adverse events were observed in these volunteers.

Key Points:

➢ N-Sorb enzymes are encapsulated in the patent-pending multi-lamellar clustoidal phospholipid Prodosome® architecture to facilitate rapid absorption.➢ Unlike conventional digestive enzymes that are activated in pH ranges from 2 to 5.5, the KD120 MEC enzymes are activated in pH environments ranging from 6.5 to 8.5; i.e. in the blood and body tissues outside the GI tract.

➢ Eleven male and female volunteers (age: 20 to 71 years) suffering from gut related digestive problems, including digestive dysfunctions and leaky gut, as well as gluten allergy, consumed a minimum of one serving of N-Sorb two times per day on an empty stomach over different periods of time ranging from 1 month to 4 months

➢ All subjects reported significant improvement in gastrointestinal functions among other systemic improvements.➢ No adverse events were observed in these volunteers.

http://www.fasebj.org/content/31/1_Supplement/lb312.abstract?sid=7a6ffc42-b8f7-4ce2-95bf-2534ade9dcfe

Sustained safety and efficacy of a novel KD120 MEC multi-enzyme complex (N-Sorb®) in human volunteersBernard W Downs, Steve W Kushner, Manashi Bagchi, Anand Swaroop and Debasis BagchiAbstract Presented at the 22nd International Conference of Functional Foods for Chronic Disease, Harvard Medical School, Boston, MA, USA, September 22-23, 2017.

Abstract:

Background:

Digestive enzymes are taken with meals to enhance digestion. N-Sorb is a novel KD120 multi-enzyme complex (MEC) containing a range of protease, amylase, and lipase enzymes including glucoamylase and alpha-galactosidase. While conventional digestive enzymes are activated in a stomach pH 2-5.5, enzymes in the KD120 MEC are activated in pH environments ranging from 6.5-8.5. These enzymes are encapsulated in a patent-pending SK713 Soy Lecithin Phospholipid absorption technology (‘Prodosomes’) to achieve rapid absorption and delivery into the blood, and increase availability to tissues.

Methods:

Eleven case studies (Female: 9; Male: 2, age: 20-71 years) were conducted in two independent clinics. These subjects who were suffering from a range of metabolic, neuro-immuno and GI tract related problems including leaky gut and gluten allergy, consumed a minimum of one dose (1/8 tsp Prodosomes and 1/8 tsp enzyme powder mixed into 4 ounces of water) two times per day on an empty stomach over different periods of time ranging from 1 month to 8 months with follow up (F/U) after several months. Subjects were compliant based on product usage and replacement.

Results:

Clinic #1 in California: Six subjects participated in this study, and reported significant improvement in GI functions and other systemic symptoms including chronic fatigue, chronic musculoskeletal pain, leaky gut syndrome and othersClinic #2 in Pennsylvania:Five subjects participated in this study, 4 of whom reported significant improvement in GI functions and other systemic symptoms and well-being.

Conclusions:

Taking the KD120 MEC (N-Sorb), overall 10 (of 11) subjects reported significant improvement in gastrointestinal functions among other systemic improvements. Follow up after several months demonstrated sustained improvements in 9 of these volunteers with no reported adverse reactions.

Key Points:

➢ This is a follow-up evaluation on a previous study of 11 subjects from two independent clinics, suffering from a range of metabolic, neuro-immuno and GI tract related problems including leaky gut and gluten allergy.

➢ The KD120 MEC enzymes are encapsulated in a patent-pending SK713 SL Phospholipid absorption technology (‘Prodosomes’) to achieve rapid absorption and delivery into the blood, and increase availability to tissues.

➢ The subjects consumed a minimum of one dose of N-Sorb two times per day on an empty stomach over different periods of time ranging from 1 month to 8 months with follow up (F/U) after several months.

➢ Taking the KD120 MEC (N-Sorb), overall 10 (of 11) subjects reported significant improvement in gastrointestinal functions among other systemic improvements.➢ Follow up after several months demonstrated sustained improvements with no adverse reactions in 9 of these volunteers including OCD, anger issues, brain fog, joint pain, musculoskeletal pain, depression, anxiety, fatigue; difficulty reading, writing and coordination; growth abnormalities food allergies; and GI pain among others. One subject reported no significant improvements and discontinued use of the product.