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

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

Tracking Information

• First Submitted Date: November 14, 2012
• First Posted Date: November 20, 2012
• Last Update Posted Date: November 27, 2012
• Study Start Date: November 2012
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Post Prandial Inflammation Markers

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 14, 2012): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2012
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

    -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01729793
• Other Study ID Numbers: NEC-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Enzyme Company
• Original Responsible Party: Same as current
• Current Study Sponsor: National Enzyme Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Dale Wilson, MD; KGK Synergize

• PRS Account: National Enzyme Company
• Verification Date: November 2012