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History of Changes for Study: NCT01729793
Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
Latest version (submitted November 26, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 14, 2012 None (earliest Version on record)
2 November 26, 2012 Recruitment Status, Study Status, Contacts/Locations and Outcome Measures
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Study NCT01729793
Submitted Date:  November 14, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: NEC-001
Brief Title: Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
Official Title: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2012
Overall Status: Recruiting
Study Start: November 2012
Primary Completion: December 2012 [Anticipated]
Study Completion: December 2012 [Anticipated]
First Submitted: November 14, 2012
First Submitted that
Met QC Criteria:
November 14, 2012
First Posted: November 20, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 14, 2012
Last Update Posted: November 20, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Enzyme Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
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.
Open or close this module Conditions
Conditions: Post Prandial Inflammation Markers
Keywords: TNFalpha
IL6
postprandial
digestive
inflammation
IL1beta
CRP
CBC
ESR
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • NEC formula #C372
Placebo Comparator: Placebo
Capsule identical to active arm containing only microcrystalline cellulose
Placebo
Capsule containing microcrystalline cellulose
Other Names:
  • NEC formula #C373
Open or close this module Outcome Measures
Primary Outcome Measures:
1. TNF-alpha blood level
[ Time Frame: 0, 45 minutes, 2 hours and 4 hours ]

Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
2. IL-1beta blood level
[ Time Frame: 0, 45 minutes, 2 hours and 4 hours ]

Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
3. IL-6 Blood Level
[ Time Frame: 0, 45 minutes, 2 hours, 4 hours ]

Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
4. hsCRP Blood Level
[ Time Frame: 0, 45 minutes, 2 hours, 4 hours ]

Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
5. CBC Panel
[ Time Frame: 0, 4 hours ]

Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
6. ESR blood test
[ Time Frame: 0, 4 hours ]

Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Secondary Outcome Measures:
1. Questionaire: Gastrointestinal Symptoms
[ Time Frame: 4 hours ]

The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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

    -

Open or close this module Contacts/Locations
Central Contact Person: Dale Wilson, MD
Telephone: 519-438-9374
Study Officials: Dale Wilson, MD
Study Director
KGK Synergize
Locations: Canada, Ontario
KGK Synergize Inc.
[Recruiting]
London, Ontario, Canada, N6A 5R8
Contact:Contact: Dale Wilson, MD 519-438-9374
Contact:Principal Investigator: Dale Wilson, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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