Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal

November 26, 2012 updated by: National Enzyme Company

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 markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha), interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal. A full complete blood count (CBC)and an erythrocyte sedimentation rate (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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 5R8
        • KGK Synergize Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 consent
  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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Digestive Enzyme #2
A proprietary blend of dietary supplement enzymes in a capsule
Contains dietary supplement proteases, lipases and carbohydrases
Other Names:
  • NEC formula #C372
Placebo Comparator: Placebo
Capsule identical to active arm containing only microcrystalline cellulose
Capsule containing microcrystalline cellulose
Other Names:
  • NEC formula #C373

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNF-alpha blood level change from time 0
Time Frame: 0, 45 minutes, 2 hours and 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
0, 45 minutes, 2 hours and 4 hours
IL-1beta blood level change from time 0
Time Frame: 0, 45 minutes, 2 hours and 4 hours
Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
0, 45 minutes, 2 hours and 4 hours
IL-6 Blood Level change from time 0
Time Frame: 0, 45 minutes, 2 hours, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
0, 45 minutes, 2 hours, 4 hours
hsCRP Blood Level change from time 0
Time Frame: 0, 45 minutes, 2 hours, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
0, 45 minutes, 2 hours, 4 hours
CBC Panel change from time 0
Time Frame: 0, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
0, 4 hours
ESR blood test change from time 0
Time Frame: 0, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
0, 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionaire: Gastrointestinal Symptoms
Time Frame: 4 hours
The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Dale Wilson, MD, KGK Synergize

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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