Potential Allergens in Wine: Double-blind Placebo-controlled Trial

Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis

This study is designed to identify whether wines which are produced using the common potential food allergens such as proteins derived from fish, milk or egg are likely to contain sufficient food allergens to cause allergic reactions in susceptible individuals.

Study Overview

• Status: Completed
• Conditions: Food Allergy; Anaphylaxis
• Intervention / Treatment: Drug: Administration of wine fined with potential food allergens

Detailed Description

Recent international legislation requires labelling of wines made using potentially allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated milk where "there is detectable residual processing aid". However it is not clear whether the final wine contains concentrations of residual added food proteins that can provoke allergic reactions.

Comparison:This study is a double blind, placebo-controlled trial to determine whether adults known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following consumption of Australian commercial wines fined with food allergens.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • AIR Med, Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -

Exclusion Criteria:

Major asthma or cardiac disease Unwilling or unable to participate

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Allergic reactions to wine

Secondary Outcome Measures

Outcome Measure
Positive basophil activiation test to wines

Collaborators and Investigators

• Sponsor: Bayside Health
• Collaborators: National Health and Medical Research Council, Australia; The Alfred; Australian Wine Research Institute
• Investigators: Study Director: Robyn E O'Hehir, MBBS PhD FRACP, Alfred Hospital and Monash University; Principal Investigator: Jennifer M Rolland, PhD, Monash University; Principal Investigator: Creina S Stockley, PhD, The Australian Wine Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: egg allergy; Food allergy; nut allergy; fish allergy; milk allergy; wine
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Anaphylaxis
• Other Study ID Numbers: 124/02; Number 124/02