The Effect of Wobenzym PS on Inflammation

NCT01848808 | Completed

• 1 other identifier: INAF-2012-076
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Sub-clinical Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in the expression of anti- and pro-inflammatory genes in total blood RNA from white blood cells (WBC)

  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

  At the end of the two 4-weeks supplementation (week 4 and week 12)

Study Arms (2)

Wobenzym PS

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Wobenzym PS DIETARY_SUPPLEMENT

Wobenzym PS

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 18-75 years
• Subclinical inflammation (CRP levels \> 1 mg/L and \< 10 mg/L)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Atrium Innovations: collaborator

Study Sites (1)

Institute of nutrition and functionnal foods

Québec, Quebec, G1V 0A6, Canada

Location

Study Officials

• Benoît Lamarche, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 8, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

CA (1)