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

This study has been completed.
Sponsor:
Collaborators:
Australian Wine Research Institute
National Health and Medical Research Council, Australia
The Alfred
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163735
First received: September 12, 2005
Last updated: December 3, 2013
Last verified: September 2005
  Purpose

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 Intervention
Food Allergy
Anaphylaxis
Drug: Administration of wine fined with potential food allergens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Allergic reactions to wine

Secondary Outcome Measures:
  • Positive basophil activiation test to wines

Enrollment: 48
Study Start Date: August 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

-

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163735

Locations
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
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
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163735     History of Changes
Other Study ID Numbers: 124/02, Number 124/02
Study First Received: September 12, 2005
Last Updated: December 3, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Food allergy
wine
milk allergy
egg allergy
nut allergy
fish allergy

Additional relevant MeSH terms:
Hypersensitivity
Anaphylaxis
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 21, 2014