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

NCT ID: NCT01729793

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Post Prandial Inflammation Markers

Keywords

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TNFalpha IL6 postprandial digestive inflammation IL1beta CRP CBC ESR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Digestive Enzyme #2

A proprietary blend of dietary supplement enzymes in a capsule

Group Type ACTIVE_COMPARATOR

Digestive Enzyme #2

Intervention Type DIETARY_SUPPLEMENT

Contains dietary supplement proteases, lipases and carbohydrases

Placebo

Capsule identical to active arm containing only microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Capsule containing microcrystalline cellulose

Interventions

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Digestive Enzyme #2

Contains dietary supplement proteases, lipases and carbohydrases

Intervention Type DIETARY_SUPPLEMENT

Placebo

Capsule containing microcrystalline cellulose

Intervention Type OTHER

Other Intervention Names

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NEC formula #C372 NEC formula #C373

Eligibility Criteria

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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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Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Enzyme Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dale Wilson, MD

Role: STUDY_DIRECTOR

KGK Synergize

Locations

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KGK Synergize Inc.

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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NEC-001

Identifier Type: -

Identifier Source: org_study_id