The Effect of Wobenzym PS on Inflammation (WO)
|ClinicalTrials.gov Identifier: NCT01848808|
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : April 2, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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) ]
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848808
|Institute of nutrition and functionnal foods|
|Quebec, Canada, G1V 0A6|
|Principal Investigator:||Benoît Lamarche, PhD||Laval University|