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September 23-24, 2019 | Prague, Czech Republic
2
nd
International Conference on
Palliative Care
Clinical Trials and Pharmacovigilance
Joint Event
&
Notes:
EfficacyofN-SORB®aproprietaryKD120MECmetabolically activatedenzyme formulation:
A randomized, double-blind, placebo-controlled study
Rui Guo
1
, Sreejayan Nair
1
, Derek Smith
2
, Bledar Bisha
3
, Rama Nair
4
, Bernard W Downs
5
, Steve Kushner
6
, Debasis
Bagchi
5,7
and
Manashi Bagchi
8
1,2,3,4
University of Wyoming, USA
5
Victory Nutrition International Inc, USA
6
ALM R&D, USA
7,8
University of Houston, USA
Background:
Enzymes are crucial for all aspects of metabolic
function. Digestive enzymes from natural sources have been
creditedwithbeneficial effects in thedigestionandabsorption
of food. N-SORB is a novel KD120multienzyme 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 in
healthy male and female volunteers on blood parameters,
immunity, body composition, physical health, and quality of
life (QOL).
Methods:
Forty-six male and female (mean age: 25.8 - 12.1
years) healthy volunteers, were randomly assigned to receive
eitherN-SORB(1mL,twicedaily)orplacebofor90consecutive
days. Complete blood count, as well as blood glucose, liver
enzymes, and lipid profile were assessed pre- and post-
intervention. Serumcytokine 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. Changes in quality of life
was examined using the World Health Organization QOL-
abbreviated version (WHOQOL-BREF) and sleep quality was
assessed using the 24-item Pittsburgh Sleep Quality Index
(PSQI) questionnaire. Adverse events were monitored.
Results:
A total of 40 subjects successfully completed the
study. Compared to placebo, changes in blood cell counts
including haematocrit, haemoglobin, mean corpuscular
volume, platelets and lymphocytes provide evidence of some
improvement. QOL parameters showed a small but significant
improvement in the N-SORB group. A significant increase
was observed in AST 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 BUN, serum
creatinine, ALP, ALT, and lipid profile were observed.
Conclusion:
This study demonstrates that short-term
intervention with N-SORB improves the QOL and PSQI in
healthy volunteers and marginally improved cardiometabolic
parameters, lipid profile or body composition. No adverse
effects were reported.
Speaker Biography
Manashi Bagchi is the professor in the University of Houston College of
Pharmacy at USA. Her research interest is clinical pharmacy.
e:
mbagchi08@gmail.comJournal of Clinical Research and Pharmacy | Volume 2
J Clin Res Pharm, Volume:2