A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a
digestive enzyme dietary supplement product, on markers indicative of inflammation after a
meal. The study design is a randomized, double-blind, placebo-controlled, cross-over type
study. The markers will be assessed by blood levels TNF-alpha, IL-1beta, IL-6, and hsCRP at
times 0, 45 minutes, 2 hours and 4 hours post-meal. A full blood CBC panel and an ESR blood
test will also be conducted at times 0 and 4 hours post-meal. In addition, a questionaire on
Gastrointestinal symptoms will be administered 4 hours post-meal. The study hypothesis is
that some or all of these potential markers of inflammation will increase following the
meal, and the amount of increase in inflammation will be attenuated when a digestive enzyme
is consumed with the meal compared to the placebo. In addition, it is hypothesized that
levels of gastric discomfort as assessed by the questionaire will be reduced with the
digestive enzyme compared to the placebo.
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
TNF-alpha blood level change from time 0
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
0, 45 minutes, 2 hours and 4 hours
No
Dale Wilson, MD
Study Director
KGK Synergize
Canada: Health Canada
NEC-001
NCT01729793
November 2012
December 2012
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