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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Food Allergy Anaphylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Administration of wine fined with potential food allergens

Intervention Type DRUG

Eligibility Criteria

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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

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robyn E O'Hehir, MBBS PhD FRACP

Role: STUDY_DIRECTOR

Alfred Hospital and Monash University

Jennifer M Rolland, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Creina S Stockley, PhD

Role: PRINCIPAL_INVESTIGATOR

The Australian Wine Research Institute

Locations

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AIR Med, Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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Number 124/02

Identifier Type: -

Identifier Source: secondary_id

124/02

Identifier Type: -

Identifier Source: org_study_id

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