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A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal

19 Years
80 Years
Open (Enrolling by invite only)
Post Prandial Inflammation Markers

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Trial Information

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.

Inclusion Criteria:

1. If female, not of child bearing potential. Defined as females who have had a
hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal
(natural or surgical with >1 year since last menstruation). OR Female subject of
childbearing potential must agree to use a medically approved method of birth control
and have a negative urine pregnancy test result.

2. Healthy as determined by laboratory results, medical history and physical exam

3. Agrees to comply with study protocols

4. Has given voluntary, written, informed consent to participate in the study -

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the
course of the trial.

2. Gastrointestinal lesions/ulcer, diabetes, or any condition requiring the use of
prescribed medications for treatment

3. Immunocompromised individuals such as subjects that have undergone organ
transplantation or subjects diagnosed with human immunodeficiency virus (HIV)

4. History of or current diagnosis of any cancer (except for successfully treated basal
cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer
in full remission more than 5 years after diagnosis are acceptable.

5. History of bleeding disorders, or significant blood loss in the past 3 months

6. Use of blood thinning medications.

7. Use of anti-inflammatory medications, including over-the-counter pain relievers
within the past 14 days.

8. Use of prescription medication (other than birth control), vitamins, minerals or
other natural health products within the past 3 days. .

9. Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within
the past year

10. Allergy or sensitivity to study supplement ingredients, study meal ingredients or
allergy or sensitivity to yeasts or molds/fungi.

11. Participation in a clinical research trial within 30 days prior to randomization

12. Individuals who are cognitively impaired and/or who are unable to give informed

13. Use of fish oil supplements within 10 days of randomization and during the trial

14. Any other condition which in the Investigator's opinion may adversely affect the
subject's ability to complete the study or its measures or which may pose significant
risk to the subject


Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

TNF-alpha blood level change from time 0

Outcome Description:

Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

Outcome Time Frame:

0, 45 minutes, 2 hours and 4 hours

Safety Issue:


Principal Investigator

Dale Wilson, MD

Investigator Role:

Study Director

Investigator Affiliation:

KGK Synergize


Canada: Health Canada

Study ID:




Start Date:

November 2012

Completion Date:

December 2012

Related Keywords:

  • Post Prandial Inflammation Markers
  • TNFalpha
  • IL6
  • postprandial
  • digestive
  • inflammation
  • IL1beta
  • CRP
  • CBC
  • ESR
  • Inflammation