Clinical trial NCT01729793: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post Prandial Inflammation Markers
Keywords: TNFalpha
IL6
postprandial
digestive
inflammation
IL1beta
CRP
CBC
ESR
Lead sponsor: National Enzyme Company
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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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Primary outcomes:
measure: TNF-alpha blood level change from time 0
timeFrame: 0, 45 minutes, 2 hours and 4 hours
measure: IL-1beta blood level change from time 0
timeFrame: 0, 45 minutes, 2 hours and 4 hours
measure: IL-6 Blood Level change from time 0
timeFrame: 0, 45 minutes, 2 hours, 4 hours
measure: hsCRP Blood Level change from time 0
timeFrame: 0, 45 minutes, 2 hours, 4 hours
measure: CBC Panel change from time 0
timeFrame: 0, 4 hours
measure: ESR blood test change from time 0
timeFrame: 0, 4 hours
Secondary outcomes:
measure: Questionaire: Gastrointestinal Symptoms
timeFrame: 4 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Synergize
name: Dale Wilson, MD
role: STUDY_DIRECTOR
References: