Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
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ClinicalTrials.gov Identifier: NCT01729793 |
Recruitment Status : Unknown
Verified November 2012 by National Enzyme Company.
Recruitment status was: Enrolling by invitation
First Posted : November 20, 2012
Last Update Posted : November 27, 2012
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Condition or disease | Intervention/treatment | Phase |
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Post Prandial Inflammation Markers | Dietary Supplement: Digestive Enzyme #2 Other: Placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
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Active Comparator: Digestive Enzyme #2
A proprietary blend of dietary supplement enzymes in a capsule
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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
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Other: Placebo
Capsule containing microcrystalline cellulose
Other Name: NEC formula #C373 |
- 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
- Questionaire: Gastrointestinal Symptoms [ Time Frame: 4 hours ]The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.

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Ages Eligible for Study: | 19 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729793
Canada, Ontario | |
KGK Synergize Inc. | |
London, Ontario, Canada, N6A 5R8 |
Study Director: | Dale Wilson, MD | KGK Synergize |
Responsible Party: | National Enzyme Company |
ClinicalTrials.gov Identifier: | NCT01729793 |
Other Study ID Numbers: |
NEC-001 |
First Posted: | November 20, 2012 Key Record Dates |
Last Update Posted: | November 27, 2012 |
Last Verified: | November 2012 |
TNFalpha IL6 postprandial digestive inflammation |
IL1beta CRP CBC ESR |
Inflammation Pathologic Processes |