Back to results

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

Primary Purpose

Post Prandial Inflammation Markers

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Digestive Enzyme #2

Placebo

About this trial

This is an interventional basic science trial for Post Prandial Inflammation Markers focused on measuring TNFalpha, IL6, postprandial, digestive, inflammation, IL1beta, CRP, CBC, ESR

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 -

Exclusion Criteria:

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
-

Sites / Locations

KGK Synergize Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Digestive Enzyme #2

Placebo

Arm Description

A proprietary blend of dietary supplement enzymes in a capsule

Capsule identical to active arm containing only microcrystalline cellulose

Outcomes

Primary Outcome Measures

TNF-alpha blood level change from time 0

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

IL-1beta blood level change from time 0

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

IL-6 Blood Level change from time 0

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

hsCRP Blood Level change from time 0

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

CBC Panel change from time 0

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

ESR blood test change from time 0

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

Secondary Outcome Measures

Questionaire: Gastrointestinal Symptoms

The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.

Full Information

NCT ID

NCT01729793

First Posted

November 14, 2012

Last Updated

November 26, 2012

Sponsor

National Enzyme Company

1. Study Identification

Unique Protocol Identification Number

NCT01729793

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2012 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Enzyme Company

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Prandial Inflammation Markers

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Digestive Enzyme #2

Arm Type

Active Comparator

Arm Description

A proprietary blend of dietary supplement enzymes in a capsule

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Capsule identical to active arm containing only microcrystalline cellulose

Intervention Type

Dietary Supplement

Intervention Name(s)

Digestive Enzyme #2

Other Intervention Name(s)

NEC formula #C372

Intervention Description

Contains dietary supplement proteases, lipases and carbohydrases

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

NEC formula #C373

Intervention Description

Capsule containing microcrystalline cellulose

Primary Outcome Measure Information:

Title

TNF-alpha blood level change from time 0

Description

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

Time Frame

0, 45 minutes, 2 hours and 4 hours

Title

IL-1beta blood level change from time 0

Description

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

Time Frame

0, 45 minutes, 2 hours and 4 hours

Title

IL-6 Blood Level change from time 0

Description

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

Time Frame

0, 45 minutes, 2 hours, 4 hours

Title

hsCRP Blood Level change from time 0

Description

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

Time Frame

0, 45 minutes, 2 hours, 4 hours

Title

CBC Panel change from time 0

Description

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

Time Frame

0, 4 hours

Title

ESR blood test change from time 0

Description

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

Time Frame

0, 4 hours

Secondary Outcome Measure Information:

Title

Questionaire: Gastrointestinal Symptoms

Description

The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 - Exclusion Criteria: 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dale Wilson, MD

Organizational Affiliation

KGK Synergize

Official's Role

Study Director

Facility Information:

Facility Name

KGK Synergize Inc.

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5R8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs