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

Not Applicable

• Conditions: Post Prandial Inflammation Markers
• Interventions: Other: Placebo; Dietary Supplement: Digestive Enzyme #2

• Registration Number: NCT01729793
• Lead Sponsor: National Enzyme Company

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.

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-27
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsule identical to active arm containing only microcrystalline cellulose
Digestive Enzyme #2	Digestive Enzyme #2	A proprietary blend of dietary supplement enzymes in a capsule

Primary Outcome Measures

Name	Time	Method
TNF-alpha blood level change from time 0	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	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	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	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	0, 4 hours	Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
ESR blood test change from time 0	0, 4 hours	Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal

Secondary Outcome Measures

Name	Time	Method
Questionaire: Gastrointestinal Symptoms	4 hours	The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.

Trial Locations

Locations (1)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada