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The Effect of Wobenzym PS on Inflammation (WO)

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ClinicalTrials.gov Identifier: NCT01848808
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : April 2, 2014
Sponsor:
Collaborator:
Atrium Innovations
Information provided by (Responsible Party):
Benoit Lamarche, Laval University

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 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.


Condition or disease Intervention/treatment Phase
Sub-clinical Inflammation Dietary Supplement: Wobenzym PS Dietary Supplement: Placebo Not Applicable

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 correlated and often found co-segregating among individuals with obesity and metabolic syndrome. There is increasing evidence to support the use in clinical practice of these novel markers of atherosclerosis and CVD risk. C-reactive protein (CRP) has been used extensively as a non-specific marker of acute phase response in clinical practice for decades. More recently, CRP has also been proposed to be a new cardiovascular biomarker of atherosclerosis and its complications. Studies that have investigated the predictive value of sub-acute CRP levels have been relatively consistent in showing that individuals with high hsCRP (high-sensitivity C-reactive protein) levels (>3.0 mg/L) were at greater risk of CVD compared to individuals with lower (<1.0 mg/L) hsCRP levels, independent of gender and plasma cholesterol concentrations. Wobenzym is an enzyme formula primarily recommended for the treatment of pain and inflammation associated with musculoskeletal disorders. Several studies in the areas of arthritis and post-surgery have reported the acute anti-inflammatory effects of Wobenzym in terms of changes in CRP. Whether Wobenzym plays a role in managing sub-acute inflammation as well remains to be investigated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Wobenzym PS on Inflammation
Study Start Date : April 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : March 2014

Arm Intervention/treatment
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.
Dietary Supplement: Wobenzym PS
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.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848808


Locations
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Canada
Institute of nutrition and functionnal foods
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Atrium Innovations
Investigators
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Principal Investigator: Benoît Lamarche, PhD Laval University

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Responsible Party: Benoit Lamarche, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01848808     History of Changes
Other Study ID Numbers: INAF-2012-076
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Wobenzym
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs