Skip to main content
OpenTrials
Completed

NCT Number: NCT01848808

The Effect of Wobenzym PS on Inflammation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of nutrition and functionnal foods

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wobenzym PS

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Atrium Innovations

Registry information

Acronym: WO

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 8, 2013
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.