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Completed

NCT Number: NCT00163735

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

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.

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Key information

Conditions

Food Allergy Anaphylaxis Egg Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity Nut Hypersensitivity Nut and Peanut Hypersensitivity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIR Med, Alfred Hospital

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Administration of wine fined with potential food allergens

Drug

Primary outcomes

  1. Allergic reactions to wine

Secondary outcomes

  1. Positive basophil activiation test to wines

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Australian Wine Research Institute
  • National Health and Medical Research Council, Australia
  • The Alfred

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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