- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01848808
The Effect of Wobenzym PS on Inflammation (WO)
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 inflammation.
The study will be undertaken according to a double-blind, cross over, randomized, placebo controlled design. The study will involve men and women with subclinical inflammation (n=24). Eligible subjects will have blood CRP >1 mg/L and <10 mg/L and will be in good health. The impact of Wobenzym PS on inflammation (vs. placebo) will be assessed by comparing the blood fasting concentrations and whole blood gene expression of anti- and pro-inflammatory proteins before and after the 4-week supplementation (Wobenzym and placebo). The two 4-week supplementation will be separated by a 4-week wash out period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 0A6
- Institute of nutrition and functionnal foods
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged between 18-75 years
- Subclinical inflammation (CRP levels > 1 mg/L and < 10 mg/L)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Wobenzym PS
During the 4-week of the Wobenzym supplementation, participants will take 6 tablets of Wobenzym: 2 tablets 3 times daily at least 45 minutes before meal.
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Placebo Comparator: Placebo
During the 4-week of placebo phase, participants will take 6 tablets of placebo: 2 tablets 3 times daily at least 45 minutes before meal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the expression of anti- and pro-inflammatory genes in total blood RNA from white blood cells (WBC)
Time Frame: At the end of the two 4-weeks supplementation (week 4 and week 12)
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At the end of the two 4-weeks supplementation (week 4 and week 12)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood levels of anti- and pro-inflammatory markers
Time Frame: At the end of the two 4-weeks supplementation (week 4 and week 12)
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At the end of the two 4-weeks supplementation (week 4 and week 12)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INAF-2012-076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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