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Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People

NCT01494194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2015-06-08

No results posted yet for this study

Summary

Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient.

Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.

As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate:

* Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould.
* Whether ASP is responsible for any positive SPT reactions, should they occur.
* And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy.

The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested.

In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo \[food containing no ASP\]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking.

This is a multi centre study which is taking place in the UK.

Conditions

  • Allergy to Mold

Interventions

OTHER

Air Structuring Protein

A novel food protein preparation

OTHER

Placebo sorbet

Placebo sorbet for double blind placebo controlled food challenge

Sponsors & Collaborators

  • Unilever SEAC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494194 on ClinicalTrials.gov