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

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.

Condition or disease	Intervention/treatment	Phase
Post Prandial Inflammation Markers	Dietary Supplement: Digestive Enzyme #2; Other: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• 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
• Study Start Date: November 2012
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. 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
4. 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
5. 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
6. 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 80 Years (Adult, Older Adult)
• 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

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Contacts and Locations

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
• Other Study ID Numbers: NEC-001
• 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