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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163735
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 5, 2013
Australian Wine Research Institute
National Health and Medical Research Council, Australia
The Alfred
Information provided by (Responsible Party):
Bayside Health

Brief 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.

Condition or disease Intervention/treatment Phase
Food Allergy Anaphylaxis Drug: Administration of wine fined with potential food allergens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis
Study Start Date : August 2002
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Primary Outcome Measures :
  1. Allergic reactions to wine

Secondary Outcome Measures :
  1. Positive basophil activiation test to wines

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163735

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Australia, Victoria
AIR Med, Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Australian Wine Research Institute
National Health and Medical Research Council, Australia
The Alfred
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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
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Responsible Party: Bayside Health Identifier: NCT00163735    
Other Study ID Numbers: 124/02
Number 124/02
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: September 2005
Keywords provided by Bayside Health:
Food allergy
milk allergy
egg allergy
nut allergy
fish allergy
Additional relevant MeSH terms:
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Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate