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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163735
• Other study ID #: 124/02
• Secondary ID: Number 124/02
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 3, 2013
• Start date: August 2002
• Est. completion date: May 2006

Study information

• Verified date: September 2005
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anaphylaxis
• Food Allergy
• Food Hypersensitivity

Intervention

Drug:
• Administration of wine fined with potential food allergens

Locations

Country	Name	City	State
Australia	AIR Med, Alfred Hospital	Melbourne	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Bayside Health	Australian Wine Research Institute, National Health and Medical Research Council, Australia, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic reactions to wine
Secondary	Positive basophil activiation test to wines