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

National Enzyme Company

Status

Unknown

Conditions

Post Prandial Inflammation Markers

Treatments

Dietary Supplement: Digestive Enzyme #2

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01729793

NEC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts 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