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

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.
 
ClinicalTrials.gov Identifier: NCT01729793
Recruitment Status : Unknown
Verified November 2012 by National Enzyme Company.
Recruitment status was:  Enrolling by invitation
First Posted : November 20, 2012
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):
National Enzyme Company

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 20, 2012
Last Update Posted Date November 27, 2012
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • 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
  • 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.
  • 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
  • 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
  • CBC Panel [ Time Frame: 0, 4 hours ]
    Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
  • ESR blood test [ Time Frame: 0, 4 hours ]
    Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Questionaire: Gastrointestinal Symptoms [ Time Frame: 4 hours ]
The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Post Prandial Inflammation Markers
Intervention  ICMJE
  • Dietary Supplement: Digestive Enzyme #2
    Contains dietary supplement proteases, lipases and carbohydrases
    Other Name: NEC formula #C372
  • Other: Placebo
    Capsule containing microcrystalline cellulose
    Other Name: NEC formula #C373
Study Arms  ICMJE
  • Active Comparator: Digestive Enzyme #2
    A proprietary blend of dietary supplement enzymes in a capsule
    Intervention: Dietary Supplement: Digestive Enzyme #2
  • Placebo Comparator: Placebo
    Capsule identical to active arm containing only microcrystalline cellulose
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01729793
Other Study ID Numbers  ICMJE NEC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Enzyme Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Enzyme Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dale Wilson, MD KGK Synergize
PRS Account National Enzyme Company
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP