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

NCT01729793 | Unknown DMC

• 1 other identifier: NEC-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Prandial Inflammation Markers

Keywords

TNFalpha; IL6; postprandial; digestive; inflammation; IL1beta; CRP; CBC; ESR

Outcome Measures

Primary Outcomes (6)

• TNF-alpha blood level change from time 0

  Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

  0, 45 minutes, 2 hours and 4 hours

• IL-1beta blood level change from time 0

  Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.

  0, 45 minutes, 2 hours and 4 hours

• IL-6 Blood Level change from time 0

  Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

  0, 45 minutes, 2 hours, 4 hours

• hsCRP Blood Level change from time 0

  Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

  0, 45 minutes, 2 hours, 4 hours

• CBC Panel change from time 0

  Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

  0, 4 hours

• ESR blood test change from time 0

  Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

  0, 4 hours

Secondary Outcomes (1)

• Questionaire: Gastrointestinal Symptoms

  4 hours

Study Arms (2)

Digestive Enzyme #2

ACTIVE COMPARATOR

A proprietary blend of dietary supplement enzymes in a capsule

Dietary Supplement: Digestive Enzyme #2

Placebo

PLACEBO COMPARATOR

Capsule identical to active arm containing only microcrystalline cellulose

Other: Placebo

Interventions

Digestive Enzyme #2 DIETARY_SUPPLEMENT

Contains dietary supplement proteases, lipases and carbohydrases

Also known as: NEC formula #C372

Digestive Enzyme #2

Placebo OTHER

Capsule containing microcrystalline cellulose

Also known as: NEC formula #C373

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy as determined by laboratory results, medical history and physical exam
• Agrees to comply with study protocols
• Has given voluntary, written, informed consent to participate in the study -

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
• Gastrointestinal lesions/ulcer, diabetes, or any condition requiring the use of prescribed medications for treatment
• Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
• 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.
• History of bleeding disorders, or significant blood loss in the past 3 months
• Use of blood thinning medications.
• Use of anti-inflammatory medications, including over-the-counter pain relievers within the past 14 days.
• Use of prescription medication (other than birth control), vitamins, minerals or other natural health products within the past 3 days. .
• Alcohol use \>2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year
• Allergy or sensitivity to study supplement ingredients, study meal ingredients or allergy or sensitivity to yeasts or molds/fungi.
• Participation in a clinical research trial within 30 days prior to randomization
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Use of fish oil supplements within 10 days of randomization and during the trial
• 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

Sponsors & Collaborators

• National Enzyme Company: lead

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dale Wilson, MD

  KGK Synergize

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

CA (1)