Sub-clinical Inflammation Clinical Trial
Official title:
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention