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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by National Enzyme Company.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01729793
First Posted: November 20, 2012
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Enzyme Company
  Purpose
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.

Condition Intervention
Post Prandial Inflammation Markers Dietary Supplement: Digestive Enzyme #2 Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal

Further study details as provided by National Enzyme Company:

Primary Outcome Measures:
  • 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

  • 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.

  • 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

  • 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

  • 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

  • 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


Secondary Outcome Measures:
  • Questionaire: Gastrointestinal Symptoms [ Time Frame: 4 hours ]
    The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Digestive Enzyme #2
A proprietary blend of dietary supplement enzymes in a capsule
Dietary Supplement: Digestive Enzyme #2
Contains dietary supplement proteases, lipases and carbohydrases
Other Name: NEC formula #C372
Placebo Comparator: Placebo
Capsule identical to active arm containing only microcrystalline cellulose
Other: Placebo
Capsule containing microcrystalline cellulose
Other Name: NEC formula #C373

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729793


Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
National Enzyme Company
Investigators
Study Director: Dale Wilson, MD KGK Synergize
  More Information

Responsible Party: National Enzyme Company
ClinicalTrials.gov Identifier: NCT01729793     History of Changes
Other Study ID Numbers: NEC-001
First Submitted: November 14, 2012
First Posted: November 20, 2012
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by National Enzyme Company:
TNFalpha
IL6
postprandial
digestive
inflammation
IL1beta
CRP
CBC
ESR

Additional relevant MeSH terms:
Inflammation
Pathologic Processes