Status:
COMPLETED
The Effect of Wobenzym PS on Inflammation
Lead Sponsor:
Laval University
Collaborating Sponsors:
Atrium Innovations
Conditions:
Sub-clinical Inflammation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The general objective of this project is to examine the impact of Wobenzym PS supplementation on blood markers of inflammation and inflammation gene expression in volunteers with sub-clinical inflamma...
Detailed Description
Inflammation is being increasingly recognized as key etiological factor in the development of atherosclerosis and subsequent cardiovascular disease (CVD). This pro-atherogenic state is strongly correl...
Eligibility Criteria
Inclusion
- Men and women aged between 18-75 years
- Subclinical inflammation (CRP levels \> 1 mg/L and \< 10 mg/L)
Exclusion
- Hypersensitivity to Wobenzym PS constituents
- Severe congenital or acquired coagulation disorders (e.g. haemophilia, in dialysis patients)
- Severe liver damage
- Prior to surgical operations
- Any clinical signs or laboratory evidence for severe inflammatory, endocrine, renal/pulmonary, neurological, cardiovascular, metabolic, haematological, or psychiatric condition, which in the Investigator's opinion contraindicates a 4-week course of Wobenzym PS use
- Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma.
- Any active gastrointestinal disease
- Use of anticoagulants or thrombocyte aggregation inhibitors, chemotherapeutic agents, antibiotics, medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood disorders
- Use of NSAID (nonsteroidal antiinflammatory drug) within 1 month of entering the study
- Excessive alcohol consumption (more than two drinks by day for men, one for women) and active alcoholism; smoking; drug use and history of drug abuse; supplements or natural products consumption during the study
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01848808
Start Date
April 1 2013
End Date
March 1 2014
Last Update
April 2 2014
Active Locations (1)
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1
Institute of nutrition and functionnal foods
Québec, Quebec, Canada, G1V 0A6